Event Alert

Tuesday, September 22nd, 2020

Shakers and bioreactors are established versatile systems for cultivating microorganism, plant, and animal cells in suspension. Both methods aim at increasing the oxygen and nutrient supply in the medium to stimulate culture growth, but offer very different solutions in technique, volumes/throughput, control possibilities, and thus applications.

In this educational webinar, we will look at the biophysical background of both cultivation techniques, pros and cons, and areas of application. You will also learn how to optimize your process in shake flasks and bioreactors via proper choice of vessel type, vessel material, instrument configuration, and parameter settings. Additionally, we will introduce the use of feeding techniques bioreactors and have a glance on shakers too.

Learning Objectives:

  • Review: Why shake or stir cells and an outline of system specific differences
  • Learn how to identify the right cultivation method, vessel type, vessel material, and instrument configuration for your specific needs
  • Learn how to define and optimize important parameters to improve culture results - incl. Tips & Tricks
  • Learn about feeding possibilities in shake flasks & bioreactors and their impact on your culture  

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Tuesday, September 22nd, 2020

Raman spectroscopy is a process analytical technology for simultaneous in-line measurement of important process outputs in therapeutic protein production via mammalian cell culture, such as concentrations of key metabolites or even the protein being expressed. However, due to the complex and shifting nature of the various chemical species present in the cell culture system, Raman models will likely need to be at least partially trained on a process-specific basis. They must also be robust enough to maintain accuracy throughout the expected manufacturing process operational ranges.

This presentation is a proof-of-concept study to demonstrate a reliable Raman model can be developed in parallel with standard process development experimentation for later deployment in a scaled-up manufacturing process.

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Tuesday, September 22nd, 2020

Automated sampling in the Upstream Bioprocess has been around since the 90's but until recently, the technology had not reached a level that would move automated sampling from an early experiment to efficient way of decreasing the workload and reducing risks involved in manual sampling. And many are not aware of the full capabilities in automated sampling and how to get the most from the system. This webinar will talk about how to improve your bioprocess with next generation automated sampling systems designed to meet the sampling challenges. It will also touch on how Flownamics Seg-Flow performs automated sampling, the best practices for optimal Seg-Flow performance, and how to fully utilize the Seg-Flow's capabilities.

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Thursday, September 17th, 2020

Documenting studies on paper or Excel spreadsheets reduces efficiency and increases the chance of errors. The IDBS Bioanalysis Solution is a scientific informatics process execution system that supports all bioanalytical documentation needs - streamlining workflows in the lab and boosting compliance. The solution goes beyond traditional ELN and LIMS functionality, covering all aspects of the bioanalytical testing workflow, from ensuring method compliance to minimize deviations and errors and safeguarding data integrity, to easing the audit process and reducing the reporting time. 

In this demo, Craig Williamson, Solutions Consultant at IDBS, shows what the IDBS Bioanalysis Solution includes, what makes the configurable templates transformational, and how labs can benefit.

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Thursday, September 17th, 2020

Register now for our free panel discussion exploring current practises and challenges in the field of iPSC expansion and differentiation.

This panel discussion, featuring experts from institutions across the world, will focus on the variations in methods as well as the challenges faced by scientists in this field of research. It aims to assess the current state of the field by discussing the many different techniques used in iPSC differentiation and expansion and will consider how these processes may evolve in the future.

What will you learn?

  • The main techniques, technologies and materials currently in use
  • The current challenges faced in the differentiation and expansion of high-quality iPSCs
  • The future potential of iPSCs in therapies and other applications
  • How the technologies and techniques used to manufacture iPSCs may evolve

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Tuesday, September 15th, 2020
Thursday, September 17th, 2020

With multiple products on the market, gene therapy has now gone beyond proof of concept and entered mainstream healthcare. This success urgently requires work on manufacturing processes to ensure that gene therapies are widely available to all that need them. Furthermore, regulatory authorities, tasked with assuring quality, efficacy and safety of the final product, are placing increasing scrutiny on the manufacturing process. Regulatory guidance documents suggest that the risk of adventitious agent contamination should be assessed and mitigated through a risk-based approach.

In this webinar, we will outline key considerations in choosing the right technology for scale up in adherent and suspension cell cultures and some of the pitfalls that must be overcome to ensure success at large scale. Furthermore, we will detail a process control strategy to mitigate the risk of adventitious agent contamination.

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Wednesday, September 16th, 2020

Multiparticulate (MP) dosage forms provide opportunities to modulate drug release characteristics and target specific release sites within the GI tract. Fluid bed bottom-spray (Wurster) coating is routinely used to apply successive coating layers in the development and manufacture of these multiparticulate formulations.

In this webinar, experts in multiparticulate applications from Colorcon and Innopharma Technology will discuss how computational design and PAT can help build more robust formulations, predict multiparticulate performance, and accelerate development by reducing traditional iterative trial and testing practices in development.

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Monday, September 14th, 2020

Streamlining processes, ensuring consistency and risk reduction are widely sought objectives in the analytical laboratory. As sample volumes increase against fixed resources, especially in the contract market, service providers often turn to software to enable their people to meet these goals. The most effective solutions recognize the importance of direct integration of instrumentation with software to establish closed-loop, compliance workflows. With its latest product innovations, IDBS continues to find new ways to help R&D organizations capture, manage, and gain insights from their scientific and operational data. The company is excited to announce the release of a new integration component with SCIEX Analyst™, for both cloud and on-premise platforms of E-WorkBook.

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Thursday, September 10th, 2020

The BioProfile FLEX2 On-Line Autosampler (OLS) is a modular system that connects as many as 10 bioreactors to a FLEX2 analyzer for automated sampling and analysis of key cell culture analytes including pH, gases, metabolites, osmometry, cell density, and cell viability. The OLS' small sample volume and fast analysis time provide automated sampling and analysis of 10 bioreactors in less than 1.5 hours. Setup time for a full, 10-bioreactor system requires less than 20 minutes. With proven data comparability to manual sampling methods, the FLEX2 OLS can be connected to OPC-compliant control systems for automated sampling, analysis, and feedback control.

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Thursday, September 10th, 2020

The webinar focuses on applications within the pharmaceutical industry such as WFI and CIP processes. Practical examples will show how the SAW technology can be used to gain filling time, improve quality and reduce maintenance efforts. The audience will get to know how this new technology meets the highest hygienic standards. Since there is no sensor element in the tube, this design guarantees that the liquid is not contaminated, and the device supports hygienic cleaning processes. In addition, the flow sensor is able to measure several parameters; flow, temperature, density and detect any bubbles in the liquid at the same time.

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Thursday, September 3rd, 2020

In Hani's two-part webinar series, he will share data from recent research collaborations with UCL and NIBRT, exploring the impact of applying flow-through chromatography with nonwovens on clearance of soluble impurities, particularly Host Cell DNA. The research begins by investigating the impact of DNA removal prior to Protein A chromatography on the clearance of key problematic host cell proteins tracked using sophisticated LC-MS techniques. It will then show how DNA clearance during clarification can enhance the performance of Continuous Protein A Capture Chromatography. Building on the earlier webinars, these webinars are intended for new and experienced Process Development Scientists alike.

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September 2nd, 3rd, 9th and 10th, 2020

Data Integrity continues to be a major concern for Health Authorities and the pharmaceutical industry. Even though data integrity is a foundational requirement of all GXP regulations, there continues to be an increased focus on this topic both from a regulatory and industry perspective as data integrity breaches still drive a significant number of Health Authority enforcement actions such as Warning Letters, Import Alerts, product quarantines, and suspension or revocation of Marketing Authorizations.  Moreover, additional guidelines and regulations have been published to establish Data Integrity Standards.

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Tuesday, September 1st, 2020

Increasing demand for blood transfusions, but also safety towards emerging diseases of these call for new technologies to obtain red blood cells (RBC) for transfusion. Using cell culture techniques, erythroblasts, the precursor of RBCs can be proliferated at a small scale. For medical applications, a massive scale-up is required. Not only in volume but also cost-efficiency. Using engineering approaches, especially modeling and bioreactor cultivation systems, a significant increase in cell density and final cell titer were achieved.

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Tuesday, September 8th, 2020

The BioProfile FLEX2 On-Line Autosampler (OLS) is a modular system that connects as many as 10 bioreactors to a FLEX2 analyzer for automated sampling and analysis of key cell culture analytes including pH, gases, metabolites, osmometry, cell density, and cell viability. The OLS' small sample volume and fast analysis time provide automated sampling and analysis of 10 bioreactors in less than 1.5 hours. Setup time for a full, 10-bioreactor system requires less than 20 minutes. With proven data comparability to manual sampling methods, the FLEX2 OLS can be connected to OPC-compliant control systems for automated sampling, analysis, and feedback control. Explore this webinar to get a detailed picture of how the FLEX2 OLS can improve your cell culture analysis operation.

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Thursday, August 27th, 2020

In Hani's two-part webinar series, he will share data from recent research collaborations with University College London (UCL) and The National Institute of Bioprocessing Research and Training (NIBRT), exploring the impact of applying flow-through chromatography with nonwovens on clearance of soluble impurities, particularly Host Cell DNA. The research begins by investigating the impact of DNA removal prior to Protein A chromatography on the clearance of key problematic host cell proteins tracked using sophisticated LC-MS techniques. It will then show how DNA clearance during clarification can enhance the performance of Continuous Protein A Capture Chromatography. Building on the earlier webinars, these webinars are intended for new and experienced Process Development Scientists alike.

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Thursday, September 10th, 2020

The webinar focuses on applications within the biopharma industry such as WFI and CIP processes. Practical examples will show how the SAW technology can be used to gain filling time, improve quality and reduce maintenance efforts. 

The audience will get to know how this new technology meets the highest hygienic standards. Since there is no sensor element in the tube, this design guarantees that the liquid is not contaminated and the device supports hygienic cleaning processes. In addition, the flow sensor is able to measure several parameters (i.e. flow, temperature, density of the liquid) and detect any bubbles in the liquid at the same time. Best practice examples from our customers in the pharmaceutical industry will show participants how they could use such a new technology to improve the safety in their own production. We will also introduce a new flow measurement technology that improves the safety of flow measurement in the biopharma industry. Compared to conventional solutions the SAW (Surface Acoustic Wave) technology offers very precise measurements and highest levels of hygiene to improve the safety of the production, reducing time and space needed for installation and measuring several parameters at the same time.

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Tuesday, August 25th, 2020

Learn more about how ZETA's method for the determination of the kLa value provides a useful tool for optimization of the bioprocess.

Bioreactors should offer ideal conditions for the growth and product formation of microorganisms or cells. This is the prerequisite for optimal quality and maximum product yield. Designing a bioreactor for the optimum process is an enormous challenge. Knowing specific performance indicators -  like the kLa value - facilitates optimization of the bioprocess.

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Thursday, August 20th, 2020

Presenter: Masa Nakamura, PhD

Mammalian cell culture continues to be the workhorse for the expression of high-value therapeutic recombinant protein modalities. As requirements for manufacturing process performance, product quality and process safety become more stringent, cell shear during clarification has become a critical consideration for both preventing product degradation and designing clarification processes. In this webinar, Masa will present on cell shear mechanisms during clarification, the impact of cell shear on product quality and strategies to mitigate cell shear in depth filtration.

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Tuesday, September 8th, 2020 @ 8:00 AM EDT

Thursday, September 10th, 2020 @ 1:00 PM EDT

The BioProfile FLEX2 On-Line Autosampler (OLS) is a modular system that connects as many as 10 bioreactors to a FLEX2 analyzer for automated sampling and analysis of key cell culture analytes including pH, gases, metabolites, osmometry, cell density, and cell viability. The OLS' small sample volume and fast analysis time provide automated sampling and analysis of 10 bioreactors in less than 1.5 hours. Setup time for a full, 10-bioreactor system requires less than 20 minutes. With proven data comparability to manual sampling methods, the FLEX2 OLS can be connected to OPC-compliant control systems for automated sampling, analysis, and feedback control. 

Explore this webinar to get a detailed picture of how the FLEX2 OLS can improve your cell culture analysis operation.

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Wednesday, August 26th, 2020

Presenter: Andrew Lees, PhD
Founder and Scientific Director
Fina Biosolutions

In this brief webinar, Dr. Lees will present a case study on a purification process for rTTHc using polymeric chromatography resins. rTTHc was expressed at high levels as a soluble, properly folded intracellular protein in Fina Bio proprietary Escherichia coli strain. The protein has a molecular weight of 50 kDa with pI ~6. Multiple resins were screened using an automated chromatography system. Nuvia Q anion-exchange (AEX) resin (120 µm) was selected as the capture step and Macro-Prep Methyl hydrophobic-interaction chromatography (HIC) resin selected for polishing step. This two-step purification protocol was optimized for scale-up, resulting in >98% pure purified target protein.

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October 5th - November 6th, 2020

This 5-day professional short course will be delivered virtually over 5 weeks from October 5th - November 6th, 2020. The course will be taught by industry professionals from BMS, Pfizer, MilliporeSigma, and UMass experts.

The trainees will learn key principles and concepts of industrial bioprocessing of protein, cell and gene therapies. The course covers recent technologies and practices of upstream, downstream and analytical bioprocessing technologies. In addition, FDA initiatives of PAT (Process Analytical Technology), Quality by Design, and Emerging Technology will be covered. The course consists of 7 modules.

The audience for this course are individuals that are involved in manufacturing, product and process development, regulatory, QA/QC and of biotech therapeutics. Attendees from academia and regulatory agencies may also benefit depending on their areas of interest and level of experience.

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On Demand

We're excited to welcome you to our webinar on BioPAT® Spectro - unlocking the full potential of Raman spectroscopy in high-throughput process development and single-use biomanufacturing. In this webinar you will discover how BioPAT® Spectro enables ultimate process monitoring and control:

  • A new Raman spectroscopy platform that is integrated in the Ambr® 15, Ambr® 250 and Flexsafe STR® bags from 50L - 2000L

  • Scalable platform with standardized optical probe interface across Ambr® and Flexsafe STR® facilitates model transfer

  • Compatible with two leading providers of Raman spectrometers: Kaiser Optical Systems and Tornado Spectral Systems

  • Full integration in Ambr® including automated data acquisition and consolidation, automated spiking with stock solutions and contextualization of Raman spectral data with all process data by the Ambr® software

  • Fully integrated and qualified BioPAT® Spectro single-use port in Flexsafe STR® bags, which shields the measurement from ambient light, reduces set-up time, and decreases contamination risks.

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Thursday, August 6th, 2020

Presenter: Ethan Lovdal Butler, PhD

In this the second part of Ethan's two-part webinar series on the fundamentals of filtration, he marries a rigorous theoretical treatment of mass transport phenomena with practical application to clarification and sterilization processes used at biopharmaceutical companies every day. Based on his lectures at the Massachusetts Institute of Technology, Ethan starts with a broad overview of filtration terminology and then delves deeply into structure-function relationships, phenomenological modelling, bench-scale analysis and process-scale sizing. These webinars are intended for new and experienced process development scientists alike and will set the foundation for advanced topics discussed in later webinars.

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Wednesday, August 12th, 2020

Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, manual data transcription and all too frequently data gaps and data integrity challenges. This webinar discusses the difference between cleanroom classification and routine environmental monitoring, outlines the FDA 21CFR part 11 ALCOA guidance and shows how the new MET ONE 3400+ non-viable air particle counter from Beckman Coulter Life Sciences can automate routine environmental monitoring programs to help manage data integrity challenges.

Learning Objectives:

  • Why ISO 14644-1:2015 cleanroom classification sample locations should not be used for routine environmental monitoring of GMP cleanrooms
  • How the FDA 2018 updated guidance on 21CFR part 11 data integrity applies to GMP cleanroom routine environmental monitoring
  • How automating routine environmental monitoring SOPs inside the air particle counter itself to form interactive sampling maps helps to automate the process and reduce human error

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On Demand

Single-use technologies (SUT) have evolved into commercial operations and drug manufacturers look for solutions to industrialize its usage in a safe and reliable way. With single-use systems (SUS) adoption, quality ownership involves shared responsibilities between supplier and end user. Additional parts of the supply and quality chain shift to supplier. Join us as we present existing good practices to ensure critical quality attributes (CQAs) of the SUS throughout their life cycle.

In this webinar, the fundamental principles of Quality Risk Management (QRM) applied to SUS adoption and validation will be discussed. In addition, participants will gain an in-depth understanding of how to define an integrity strategy for their critical SUS, as well as on how to safely Pre-Use Post Sterilization Integrity Test (PUPSIT) filters in SUS. By the conclusion of the session, all attendees should be able to define a risk mitigation strategy for SUS.

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Presenter: Ethan Lovdal Butler, PhD

Thursday, July 30th, 2020

In Ethan's two-part webinar series on the fundamentals of filtration, he marries a rigorous theoretical treatment of mass transport phenomena with practical application to clarification and sterilization processes used at biopharmaceutical companies every day. Based on his lectures at the Massachusetts Institute of Technology, Ethan starts with a broad overview of filtration terminology and then delves deeply into structure-function relationships, phenomenological modeling, bench-scale analysis and process-scale sizing.  These webinars are intended for new and experienced process development scientists alike and will set the foundation for advanced topics discussed in later webinars.

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Presenter: Rahul Pradhan, Senior Scientist, Cell Culture Development at Kymab

On Demand

During this webinar Rahul Pradhan, Senior Scientist, Kymab, will present a case study on a manufacturing cell line screening campaign for a Kymab monoclonal antibody fusion protein. The data set obtained by the integration of the BioProfile FLEX2 with ambr 15 helped final cell line selection and process scale-up. The webinar will include examples of how to leverage the feedback loop between the FLEX2 and ambr 15 to allow the generation of a high-quality data set from multiple cell lines, including a full set of cell culture and metabolic profiles, something previously only possible with larger scale bioreactor systems.

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Presenter: Ethan Lovdal Butler, PhD

Thursday, July 30th, 2020

In Ethan's two-part webinar series on the fundamentals of filtration, he marries a rigorous theoretical treatment of mass transport phenomena with practical application to clarification and sterilization processes used at biopharmaceutical companies every day. Based on his lectures at the Massachusetts Institute of Technology, Ethan starts with a broad overview of filtration terminology and then delves deeply into structure-function relationships, phenomenological modeling, bench-scale analysis and process-scale sizing. 

These webinars are intended for new and experienced process development scientists alike and will set the foundation for advanced topics discussed in later webinars.

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Tuesday, July 21st, 2020

Over the past two decades, single-use process technologies have been increasingly incorporated into the manufacturing of biopharmaceutical products. Although the reasons for implementing single-use systems for bio manufacturing are compelling, some challenges and concerns related to their use remain. Single-use versus stainless steel - this discussion has been going on for many years. Each approach has its obvious advantages and drawbacks.

In this webinar, Roland Maichin, Head of Project Development at ZETA will illustrating case studies highlighting how challenges were overcome and which best-practice solutions have been developed to execute successful hybrid system projects.

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Enhancing the Future with Innovative Medicines and Manufacturing

Monday, July 20th - Wednesday, July 22nd, 2020

The theme of the 2020 meeting is Enhancing the Future with Innovative Medicines and Manufacturing. In selecting this theme, the planning committee designed a comprehensive event that encompasses the wide-ranging interests of all PDA members. Whether you are focused on improving existing processes or delving into entirely new technologies, the PDA Annual Meeting will cover relevant information important to small molecule, and biopharmaceutical, cell and gene therapy and other modalities.

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Tuesday, July 21st, 2020

This educational webinar covers the concept of upstream bio process scaling, the importance of design space and bioreactor engineering towards scalability, followed by case studies on the successful implementation of certain scaling approaches.

The webinar concludes with an introduction of a novel scale conversion tool used for scaling parameters in a bioreactor-size-independent way to predict the best set of cell culture parameters for single-use, stirred tank bioreactors from development through to manufacturing scale.

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Tuesday, July 21st, 2020

Over the past two decades, single-use process technologies have been increasingly incorporated into the manufacturing of biopharmaceutical products. Although the reasons for implementing single-use systems for bio manufacturing are compelling, some challenges and concerns related to their use remain. Single-use versus stainless steel - this discussion has been going on for many years. Each approach has its obvious advantages and drawbacks.

Why not combine both worlds - single-use AND stainless steel - and benefit from the resulting hybrid technology? ZETA is a global pioneer in the engineering of SU/SS hybrid systems and has a track record of successful projects.

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Tuesday, July 14th, 2020

In this webinar, Pall will present case studies illustrating the benefits of leveraging industry experts, proven methods, and integrated upstream solutions to design a robust, scalable and reproducible process. What does it take to get a new biotech drug to market? The process development starts with culturing cells and requires the right technology to reliably and efficiently produce them. The capability to seamlessly move out of process development, into clinical trials, and from small to large-scale cGMP manufacturing, is essential.

Participants will learn:

1. Strategies for transferring scalable processes from pre-clinical to cGMP commercial manufacturing

2. How partnering with Pall's Accelerator process development services team will help reduce time to market

3. Innovative single-use bioreactors whether you are growing adherent or suspension cells

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Wednesday, July 15th, 2020

Everyone working with cultured cells experiences contamination at some point. Contamination by microorganisms, other mammalian cells, and volatile organic chemicals is a recurring problem in basic and applied research as well as in production of therapeutic and other biologic products. Statistics show that contamination is much more prevalent than most researchers acknowledge. Even a single contamination incident can cost significant time and money and threaten the reputation of an investigator, laboratory or product.

This presentation will:

  • Review the different types of cell culture contamination and their effects on cells.

  • Explore the ways in which contamination occurs and offer advice for preventing contamination occurrences, including some steps that few labs take on a routine basis.

  • Compare methods for contamination control in the CO2 incubator--the central equipment for cell growth--and differentiate options with efficacy data.

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Wednesday, July 8th, 2020

The world is expecting a COVID-19 vaccine in 2021. To meet this aggressive timeline, vaccine manufacturers will not have time to build dedicated facilities: the first generation of COVID-19 vaccine will rely heavily on single-use technologies to ensure rapid installation and validation of new production lines, and existing facilities will be adapted to accommodate the production of the billions of needed doses. Under such a time pressure, how can vaccine developers take the right decision and mitigate risks when it comes to equipment sizing, technology selection and layout considerations? 

The presentation will explain why it is critical to put the process at the center of all decisions; and also show different approaches in cases where processes are not fully defined and scenarios where different processes and/or scales need to be executed in the same facility. Experiences from multiple projects will be shared.

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Tuesday, June 30th, 2020

Data integrity is the extent to which all data are complete, consistent and accurate throughout the data lifecycle. It is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. 

Data integrity arrangements must ensure that the accuracy, completeness, content and meaning of data is retained throughout the data lifecycle. Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and data disposal after the record's retention period ends. System design and controls should enable easy detection of errors, omissions, and unexpected results throughout the data's life cycle.

In this webinar, data integrity requirements for filter integrity test instruments will be discussed and demonstrated, with specific focus on: static electronic record, electronic audit trail of relevant GMP parameters, access control, data backup and data transfer.

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Tuesday, June 30th, 2020

Leaders in the biopharma industry are continuing to invest heavily in Raman spectroscopic technology in the quest to convert data into value. With nearly infinite possible combinations of data which can be collected for any given process, the challenge lies in identifying the small fraction of those which can ultimately produce valuable returns on the investments needed to capture the data, and in executing upon those correctly. Faced with this quandary, many scientists and engineers at large firms are understandably risk averse about recommending a new technology investment.

This webinar will present: 

  • An overview of the quantifiable value proposition and key applications of Raman Spectroscopy in the biopharmaceutical industry
  • Illustrations of Raman technology in action using customer-proven solutions and real-world case studies from leading biopharma companies
  • An overview of the Kaiser Raman spectroscopy solution suite including analyzers, probes, and services
  • How to set realistic expectations, understanding that even the most well-developed solutions may or may not provide the returns you need to justify the investment for your specific company, but conversely, that your firm's capabilities (and ROI) is not limited to published data... it could, in fact, be even greater.

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Wednesday, June 24th, 2020

Vaccine pipelines are evolving to be more diverse and are requiring the use of different cell lines and virus types.  As the products vary, the manufacturing modes, process analytical needs, and volume requirements change along with the regulatory landscape.  The need for scalable, flexible, and single-use process development tools and manufacturing strategies are becoming increasingly important. 

This webinar will highlight using Ambr®️ 15, Ambr®️ 250, Biostat RM, and Biostat STR along with integrated process analytical technologies (PAT) to go from high throughput process development to an intensified seed train and manufacturing platform. Vaccine specific case studies will be shown for the Ambr®️ 15 and Ambr®️ 250 looking at different suspension and adherent cell lines.

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Wednesday, June 24th, 2020

Many companies have asked employees to work from home for their safety and well-being, but relying on manual sampling to collect data doesn't give you many options. Your work is in the lab, taking samples several times a day, sometimes even at night or on weekends. Join us to know more about the next generation of the industry-leading Flownamics Seg-Flow Automated Sampling System, the Seg-Flow S3, a solution designed and built for the most critical sampling applications and challenges.

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Wednesday, June 24th, 2020

The goal of the homogenization process in a bioreactor is to maximize the biological productivity, which can only be guaranteed under ideal mixing conditions. Magnetic mixing technology stands out with its many advantages compared to mechanically sealed agitators. The decision to replace conventional stirrers with magnetic mixers paves the way to reduce the contamination risk during the bioprocess, to lower production costs, and to make the equipment easier to clean. ZETA not only supplies magnetic mixers for new bioproduction plants, but also supports the retrofitting of existing bioproduction systems by providing suitable magnetic agitators and helping with their installation, operation and maintenance.

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Wednesday, June 24th, 2020

In this presentation, we will demonstrate an integrated mAbs downstream purification process to enable significant throughput improvement while removing of critical impurities. The process approach includes (1) pre-absorption filtration technology and (2) buffer additives. Through use of pre-absorption filtration technology, in combination with PROchievA protein A affinity resin, that possess high dynamic binding capacities of greater than 60 g/L, we have obtained antibodies with increased purity, while reducing overall process time.

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Thursday, June 18th, 2020

Data analytics are powerful tools which can be used to maximize process data from development to manufacturing. In this webinar we will cover how to use data analytics to simplify process scale up and facilitate technology transfer.

Key Messages from the Webinar:

  • Scale up processes can be optimized using data analysis

  • Risks associated with tech transfer can be mitigated using data analysis

  • Once you reach commercial production real-time analytics decreases risk of failure and ensures product quality and manufacturing success

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Wednesday, June 17th, 2020

The increasing number of sophisticated molecules entering today's biologics-development pipeline can pose purification challenges during process development in the biopharmaceutical industry. Join Dr. Mark Snyder as he discusses scalable purification strategies from capture to polishing of these biomolecules. Case studies to design robust purification methods and increase overall bioprocessing efficiencies will be presented.

Topics Include:

  • Hydrophobic anionic exchange mixed-mode resin, Nuvia aPrime 4A, designed for the purification of the diverse and expanding biotherapeutics
  • Calcium affinity cation exchange mixed-mode media, CHT XT, fine-tuned for superior removal of aggregates and process impurities and virus purification
  • High performance strong anion exchange resin, Nuvia HP-Q, engineered for large biomolecule purification like plasma proteins IgA and IgM, viruses and VLPs 

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Tuesday, June 16th, 2020

This 20 minute mini-webinar will discuss how YMC have adapted our Stainless Steel Twin Column Chromatography systems to operate within a single use facility. Graphics and discussions will include the enabling single use devices which allow the handshake between gamma irradiated, single use feed, buffer, and collection vessels/tubing, to a robust Stainless system which has been sanitized using NaOH. We will also include information on the automated sequences and piping design that ensures complete sanitization of all SS wetted surfaces. There will also be some forward looking information on other methods of sanitization using Ozone gas and the advantages this would have over caustic.

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NOTE: This is one in a series of ~15 webinars on twin-column "continuous" chromatography technology by YMC/ChromaCon. View all on www.biowebinar.com search term "YMC".

Tuesday, June 16th, 2020

Single-use systems are increasingly used in the manufacture of vaccine platforms as they offer ready-to-use solutions with proven quality performances, extended functionalities and operational benefits. The different virus platforms (recombinant protein, virus, viral vector or mRNA) provide new challenges for the implementation of single-use systems. 

This webinar will present how QbD and application information have been implemented for designing the SU solutions and their quality features. With the increasing need of patient and operator safety, the presentation will focus on risk analysis and mitigation action in place for standard single-use systems for storage, mixing and shipping steps. The Pre-Designed Solutions offer robust bioprocessing, reliable quality performances as well as reliable supply chain and business continuity well adapted to the needs of the different vaccines platforms.

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Thursday, June 11th, 2020

If you are working in the Biopharma industry, you are already well acquainted with the tremendous benefits it brings to the world. However, the design, development and delivery of biopharmaceutical products can pose stiff challenges for the industry. Sometimes these challenges simply lead to frustration; while at other times, they can have costly consequences. 

The Masterflex® panel with over 80 years of combined Fluid Handling experience will provide you with the tools and guidance to help all Biopharma professionals:

  • Gain time & save money using remote access technology
  • Adapt to new workplace safety guidelines
  • Maximize production through single-use solutions

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Wednesday, June 10th, 2020

As the world searches for a way to end the coronavirus pandemic, government bodies, academic collaborations and pharma companies race to produce effective new therapies and vaccine candidates for COVID-19 With more than 115 companies actively engaged in this endeavour, we see approximately 10% of these vaccine candidates focused on viral vaccine expression systems. Speed to clinic is of paramount importance; however, as producing a commercial vaccine can take many years, how can we accelerate vaccine development with speed and safety in mind? 

To meet these challenges in a pandemic situation, you can benefit from our rapid platform approaches to cell line and virus seed testing; our media manufacturing network, and our scalable single-use process solutions and process monitoring tools to simplify progression and ensure rapid release of your drug product.

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Thursday, June 11th, 2020

Research on exosomes and other forms of extracellular vesicles (EVs) have rapidly expanded over the last two decades. These lipid-enclosed, nanoscale messengers are released from cells packed with diverse cargo and can travel long distances to modify the function of target cells. Found in abundant quantities in biological fluids like blood, there is great clinical interest in using EVs as diagnostic markers or altering their properties for therapeutic delivery. Tune in to find out more about what exosomes are, how researchers study them, and what challenges remain. This talk will highlight multi-laser nanoparticle tracking analysis (NTA) with the ViewSizer 3000 and what it offers in exosome research.

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Thursday, June 11th, 2020

Laboratory scale process characterization provides in-depth process understanding and documentation of a manufacturing process needed to establish critical product and process parameters, determine proven acceptable control ranges and minimize the risk of manufacturing failures at production scale. Here we present process development and characterization strategies at Samsung Biologics required to support commercial scale manufacture of antibody therapeutics. 

The webinar will discuss approaches to demonstrate process understanding needed to develop a robust and scalable manufacturing process to support successful GMP manufacture of biologics. 

Speakers:

Kenneth Dawson Green, PhDSenior Director, Manufacturing Science & Technology Team

Thomas Rene Gervais, PhDDirector, Manufacturing Science & Technology Team - Downstream

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Thursday, June 4th, 2020

This webinar focuses on the essentials of pH measurement in a bioprocess. Measuring pH is one of the most common and routine types of analysis. But achieving good precision and accuracy requires following proper techniques. When implemented consistently across a team, efficient and effective management of pH offers significant benefits.

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Tuesday, June 9th, 2020

In a joint collaboration, Oxford Biomedica and Repligen increased the yield of viral vectors from suspension-cultured bioreactors several fold using tangential-flow depth filtration (TFDF). The yield for a single clarification step was 95% as compared to 70% by standard depth filtration. The TFDF tubular format and low shear enabled further yield increases through multiple harvests from the same seeding. A single seeded bioreactor produced two harvests of 95% and 85%. The 180% yield represents a 2.5-fold increase over a single depth-filtration harvest at 70%.

The process was shown to scale from 5 L to 50 L with an average flux of 750 LMH and three different lentiviral model systems, demonstrating broad applicability. Logistics and execution required a single filter, three AseptiQuik connections, and typically 15-20 minutes for setup and breakdown, resulting in a four-fold reduction in required footprint as compared to conventional depth filtration.

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Wednesday, June 3rd, 2020

Presented by Dan Hill, Biogen

The use of in-line Raman spectroscopy as an in-line process analytical technology (PAT), in the biotechnology industry, has matured over the past decade from a technology with promise to a standard tool for real-time, continuous monitoring of cell culture processes. There is an ever-growing body of work demonstrating successful application from metabolite and product quality monitoring to process control in both process development and GMP manufacturing environments. This presentation will describe Biogen's past efforts and strategic direction as it relates to in-line Raman spectroscopy for cell culture operations and how we intend to leverage its capability beyond metabolite monitoring and glucose feedback control to become an essential element of our Advanced Process Control efforts.

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Wednesday, June 3rd, 2020

Presented by Vincent Wiegman, University College London

The recent clinical success of several CAR-T cell therapies has led to a rise in research endeavours into every part of their manufacturing. Timelines are critical and the final product is extremely high in value, which emphasises the need for an efficient and dependable process. This webinar shows how the micro-Matrix system can be used to optimise the environmental conditions of the T Cell expansion step and it explores the impact of varying CO2 conditions on T Cell proliferation in single-use stirred miniature bioreactor systems.

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Tuesday, June 2nd, 2020

In this webinar we will cover techniques in data analytics for accelerating vaccine discovery and development. These techniques are designed to surface trends and actionable insights across a wide range of data sets to alleviate the burden researchers and developers face as they look for clues that will speed up vaccine development and identify effective treatments.

Relevant methods and use-cases covered in this webinar include:

MODDE®️ and Design of Experiments (DOE)
SIMCA®️ and Multivariate Data Analysis (MVDA)

This Webinar is aimed at those working in R&D as well as leaders responsible for looking for ways to accelerate vaccine discovery and development. 

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Wednesday, May 27th, 2020

Rapid progress in biotechnology and the ever-increasing complexity of medicines presents bioprocessing with significant challenges. Novel technologies such as single-use and continuous manufacturing are revolutionizing industry processes.

Speakers: 

Markus Brakel, Boehringer-Ingelheim Pharma GmbH & Co.KG, Senior Scientist Upstream Development«Optimization of Buffer Exchange in N-1 Perfusion»

Cédric Schirmer, ZHAW Zurich University of Applied Sciences, Research Associate«Shear Stress Investigations on Levitronix Single-Use Centrifugal Pumps»

Martin Glenz, Pall Biotech, Principal Scientist«mPath™ IoR Concentration Monitor»

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Tuesday, May 26th, 2020

In this live webinar, Jahir Kololli, the senior product manager for Hamilton's Arc intelligent sensors portfolio, shares the reasons behind the industry shift from polarographic to optical-based dissolved oxygen measurement. Further, he discusses common challenges with optical DO measurement and how those challenges are addressed with the latest generation of sensors.

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Thursday, June 11th, 2020

Research on exosomes and other forms of extracellular vesicles (EVs) have rapidly expanded over the last two decades. These lipid-enclosed, nanoscale messengers are released from cells packed with diverse cargo and can travel long distances to modify the function of target cells. Found in abundant quantities in biological fluids like blood, there is great clinical interest in using EVs as diagnostic markers or altering their properties for therapeutic delivery.

Tune in to find out more about what exosomes are, how researchers study them, and what challenges remain. This talk will highlight multi-laser nanoparticle tracking analysis (NTA) with the ViewSizer 3000 and what it offers in exosome research.

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Thursday, May 21st, 2020

The current manufacturing processes for viral vectors for gene therapy, which we can define as Gene Therapy Manufacturing 1.0 (e.g., adherent cell culture and transient expression from plasmid transfection), are not productive enough to meet the future demand considering the quickly increasing number of approved gene therapies and clinical trials. A transition is therefore ongoing to implement more productive and scalable processes, leading to Gene Therapy Manufacturing 2.0 using suspension cell culture and developing producer cell lines. Adopting the right technology solutions on this journey is essential.

In this talk we will:

  • Evaluate the near-future needs for gene therapy manufacturing

  • Discuss the major technology challenges posed to quickly develop high-productivity, -safety, and -quality manufacturing processes for viral vectors

  • Propose technology solutions for upstream (perfusion cell culture) and downstream (tangential-flow filtration and chromatography) processing to overcome these challenges.

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Wednesday, May 20th, 2020

Process developers of COVID-19 vaccines need to develop, scale up and build sustainable mass production within the fastest timelines ever in a pandemic situation, and yet must ensure the safety, purity, quality and potency of their vaccines.

We support these challenges with an integrated platform approach that achieves fast development, banking and characterization of your cell line,  rapid characterization and lot release testing of your vaccine, expedited delivery of your ready to use media and proven end-to-end single use manufacturing.

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Tuesday, May 19th - Thursday, May 21st, 2020

Join us for this live 3-day symposium that brings together scientists from around the globe to discuss their COVID-19 research findings, ideas and technical expertise. Each day leading scientists will present their work, followed by an ask-the-expert panel discussion where the audience can pose their questions to the speakers.

Each day will highlight a new topic with new speakers sharing their expertise on the following: 

- May 19: Understanding the Immune Response
- May 20: Viral Particle Detection & Characterization
- May 21: Vaccine & Therapy Development

Register today for the whole event or select sessions. SEATS ARE LIMITED for this high demand special event.

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Wednesday, May 20th, 2020

Major progress has been made in the area of gene therapy and due to improved safety and efficacy, the Adeno-Associated Virus (AAV) has emerged as an important vector for the development of gene therapies. With a growing pipeline of clinical trials, it is evident that scalable viral vector manufacturing technologies are needed by this rapidly growing industry. Next to scalability, product safety and purity needs to be demonstrated before regulatory approval is attained.

In this presentation we will discuss the benefits of implementing affinity chromatography in the downstream purification of viral vectors. The utilization of POROS™ CaptureSelect™ AAV affinity resins results in a significant improvement to the downstream process of AAV. By reducing the number of purification steps, maximizing productivity, offering scalability and process consistency, these resins can be used for clinical and commercial manufacturing.

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Tuesday, May 19th, 2020

Human mesenchymal stem cell (hMSC)-based therapies are of increasing interest in the field of regenerative medicine. In particular for allogeneic therapies, production of large amounts of hMSC is required. However, traditional planar cultivation systems are labor intensive and limited regarding scale-up potential. Stirred-tank bioreactors, on the other hand, can provide the means for controllable, scalable and cost-efficient MSC manufacturing in combination with microcarriers. The identification of suitable microcarriers and culture medium is a critical step for establishing hMSC expansion in stirred-tank bioreactors and further process development.

This webinar will showcase a state of art approach for rapid and systematic screening of various microcarriers and media for hMSC expansion in the Ambr® 15 Cell Culture system using the MODDE® software for the design and statistical analysis of the experiments. Using a DOE approach, we systematically selected the best microcarrier and culture media combinations for the expansion of MSC in stirred-tank bioreactors.

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Monday, May 18th, 2020

One major challenge of industrial productions is to reduce batch-to-batch variability and its derived additional costs. In the biopharmaceutical industry, government initiatives such as the PAT, push the implementation of real-time bio-process monitoring and control by using in-line/on-line process sensors. These tools enable efficient control of process variability, as long as they deliver reliable and accurate measurements. This challenge is best addressed by so-called "intelligent" sensors. This contribution provides a sensor specialist's view on: "What is an intelligent sensor?" At the same time we will introduce the newer generation of Intelligent Sensors for monitoring Dissolved Oxygen, Cell Density and more.

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Wednesday, May 13th, 2020

Rapid progress in biotechnology and the ever-increasing complexity of medicines presents bioprocessing with significant challenges. Novel technologies such as single-use and continuous manufacturing are revolutionizing industry processes. We at Levitronix believe that impactful bioprocessing can only be achieved if end-users, system-, and components suppliers work together. The Levitronix Bioprocessing Webinar brings industry professionals together to make a change.

Speakers:

Maria Weinberger:
"The Effect of Pressure Pulsations on Filter Fouling in TFF"

Tero Jansen: 
"Levitronix Single-Use Pump Systems in Pilot Scale TFF Applications"

Filipa Almeida:
"Advantages to Adenovirus Productivity Using a Low Shear Stress Centrifugal Pump during Biorector Perfusion"

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Wednesday, May 13th, 2020

In this webinar Svea Cheeseman, Product Manager PAT, and Dan Kopec, Product Specialist PAT North America, will showcase how our new BioPAT® Spectro is unlocking the full potential of Raman spectroscopy in high-throughput process development and single-use biomanufacturing.

Discover how BioPAT® Spectro enables ultimate process monitoring and control:

  • A new Raman spectroscopy platform that is integrated in the Ambr® 15, Ambr® 250 and Flexsafe STR® bags from 50-2000L

  • Scalable platform with standardized optical probe interface across Ambr® and Flexsafe STR® facilitates model transfer

  • Full integration in Ambr® including automated data acquisition and consolidation, automated spiking with stock solutions and contextualization of Raman spectral data

  • Fully integrated and qualified BioPAT® Spectro single-use port in Flexsafe STR® bags

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Monday, May 11th, 2020

The scope of process analytical technologies (PAT) is to make production processes reliable through reliable real-time process monitoring and control. When this applies to bioprocesses such as the ones used to produce medicines as e.g. monoclonal antibodies (mAb) or viral vaccines, "reliable" means that the process sensors have to be compliant with the Good Manufacturing Practices (GMP) guidelines. In those regulated companies, computerized systems, such as pH, dissolved oxygen or viable cell density sensors, have to be developed, manufactured and implemented according to guidances like the Good Automated Manufacturing Practices (GAMP).

In this 30-minute live webinar you will learn about:

  • The Regulations and guidances applying to process analytical solutions

  • GAMP 5 and computerized systems: what are we talking about?

  • How GMP users can leverage on suppliers all along the DQ-IQ-OQ-PQ process sensor's lifecycle
  • Examples of product and services ready for Part 11/ Annex 11 compliance  

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Thursday, May 14th, 2020

By choosing a media supplier that is prepared to partner with manufacturers through the raw materials qualification process and regional regulatory approvals, manufacturers can better address the challenges and opportunities on the road to bringing cell therapies to market.

What will you learn?

Regulatory requirements of different regions and how FUJFILM Irvine Scientific helps the customer understand:   

  • How long the regulatory approval process takes in different regions

  • Unique raw material qualification processes

  • The importance of safety and timelines for choosing a media supplier for clinical trials

  • How the right media supplier helps with media costs

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Wednesday, May 13th, 2020

The webinar will outline the use of Sartobind membrane chromatography for the purification of virus based biologics also linking to the current COVID-19 pandemic outbreak. The presentation will cover the use of virus based biologics in different biotherapeutic approaches and clearly illustrate the properties and advantages of the Sartobind portfolio in this context.

Speakers:

Ricarda Busse
Product Manager Membrane Chromatography

Consumables Carsten Voss
Product Manager Chromatography Consumables

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On Demand

In this recorded webinar Thomas Wurm, Managing Director at Single Use Support, explains the importance of scale-up technologies to the biopharma industry. The informative presentation includes interesting facts, demonstrations and studies with a tie-in to the current situation with COVID-19: as soon as one vaccine against the pandemic will be approved from FDA and EMA, how can manufacturer scale up from clinical phases to commercialization by maintaining the same product quality?

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Monday, May 4th, 2020

This presentation first describes how vaccine developers can accelerate their timelines and develop highly efficient vaccine processes by using high throughput fully automatic multi-parallel bioreactor testing tools such as ambr, DoE software and single use solutions able to operate with mammalian cells, insect cell and avian cells.

Upstream process intensification methods, scale up tools and real case data will be presented for both suspension and adherent cell culture in fed batch, concentrated fed batch or perfusion mode. In particular, we will show how intensifying the working cell bank and the seed train bioreactor with perfusion helps saving half of the consumable costs and reduces the main bioreactor cell expansion time by up to 40%.  Moreover, being able to achieve higher titers will be extremely important to keep scale up at a manageable level, which is critical during a pandemic situation.

The author will conclude by show how coupling the production bioreactor with ATF, PAT tools and online multivariate process monitoring software can provide 10 to 50 times higher cell density and full automation and predictive control of the cell culture process performance.

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Tuesday, May 5th, 2020

This 15-minute webinar presents the unique (patented) control for processes using MCSGP found on YMC Contichrom systems.  Performing Multicolumn Countercurrent Solvent Gradient Purification (MCSGP), operation with MControl significantly reduces effects on product quality caused by temperature, solvent quality, conductivity, pH and/or column variability (bed height, aging, packing quality...).

MControl compensates for peak shifts by adjusting the fractionation start:  Same product fraction position, Same product quality, Increased robustness of continuous process operation.

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Tuesday, May 12th, 2020

Dielectric spectroscopy (DS), also known as capacitance measurement, has been used as a PAT tool for vaccine and viral vector production processes (adenovirus, lentivirus reovirus, influenza, baculovirus) with mammalian and insect cells. It has been viewed as an important process control tool for continuous virus production processes. 

Numerous groups have explored this technology to monitor live cell density, identify critical events and control the process. The benefits of using capacitance technology in these applications are multifold. Considering capacitance measurement correlates with the live cell density (or more accurately, viable biovolume) profile of the culture, it provides a complete, real time and detailed picture of all of the critical events. This leads to better process monitoring, automation and control and in turn, improved productivity.

This concise webinar will comprise of a 20 minute presentation followed by a 10 minute Live Q&A.  

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On-Demand

Viewers of this webinar will learn how to make decisions faster using easy, compliant, repeatable, more accurate at-line protein concentration measurements. The SoloVPE™ Device using novel Slope Spectroscopy® technology takes the guess work out of critical bioprocessing analytics steps.

Features Include

  • No sample preparation or dilution needed
  • Reduces deviations in manufacturing floor analysis
  • Aligns multi-site analytical methods

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Wednesday, April 29th, 2020

In this virtual launch event, we will reveal a browser-based platform for data acquisition, aggregation and analysis uniquely developed by biopharma peers to effectively manage the velocity and volume of complex, disparate electronic and batch record data sources across the process and product lifecycle in near real-time.

Reserve your virtual seat today and learn how our new suite of software, specifically conceived by bioprocess engineers for bioprocess engineers, will provide you with enhanced process control, data and process analytics, faster decision-making and a deep and insightful understanding of your bioprocess.

Learn More

Monday May 4th, 2020

We are all witness to the impact of the COVID-19 pandemic across the world, as it is bringing economies and life in general to a halt. In response to this pandemic, there are more than 90 vaccine candidates today that are in pre-clinical phase, with a few companies entering clinical trial phase I. We know that speed is of essence and that scale-up to large-scale production needs to be achieved by strategically balancing risks and speed.

This presentation will first describes how vaccine developers can accelerate their timelines and develop highly efficient vaccine processes by using high throughput fully automatic multi-parallel bioreactor testing tools such as ambr®️, DoE software and single use solutions able to operate with mammalian cells, insect cell and avian cells. 

It will conclude by showing how coupling the production bioreactor with ATF, PAT tools and online multivariate process monitoring software can provide 10 to 50 times higher cell density and a the full automation and predictive control of the cell culture process performance.

Learn More

Wednesday, May 13th, 2020

Rapid progress in biotechnology and the ever-increasing complexity of medicines presents bioprocessing with significant challenges. Novel technologies such as single-use and continuous manufacturing are revolutionizing industry processes. We at Levitronix believe that impactful bioprocessing can only be achieved if end-users, system, and component suppliers work together. The Levitronix Bioprocessing Webinar brings industry professionals together to make a change.

Speakers:

Maria Weinberger, Technical University of Munich, Research Associate
"The Effect of Pressure Pulsations on Filter Fouling in TFF"

Filipa Almeida, Psioxus, Process  Development Scientist
"Advantages to Adenovirus Productivity Using a Low   Shear Stress Centrifugal Pump during Biorector Perfusion"

Tero Jansen, Biovian, Process Engineer
"Levitronix Single-Use Pump Systems in Pilot Scale TFF Applications"

Learn More

Wednesday, April 29th, 2020

In this virtual launch event, we will reveal:

A browser-based platform for data acquisition, aggregation and analysis uniquely developed by biopharma peers to effectively manage the velocity and volume of complex, disparate electronic and batch record data sources across the process and product lifecycle in near real-time.

Reserve your virtual seat today and learn how our new suite of software, specifically conceived by bioprocess engineers for bioprocess engineers, will provide you with enhanced process control, data and process analytics, faster decision-making and a deep and insightful understanding of your bioprocess.

Learn More

On-Demand

Dielectric spectroscopy has been successfully used in the bioprocess industry to measure cell density in bioreactors for close to three decades. With FDA's PAT initiative, capacitance based cell density measurements have become even more relevant and valuable.The ability to measure viable cells exclusively, in-situ and in real time makes this technology stand apart from others. Over the years, it has been used for a variety of applications that include not only monitoring the cells, but also automatically controlling a critical aspect of the process.

In this webinar you will learn:

  • How dielectric spectroscopy is used to measure viable biomass in real-time.
  • Understand how the technology has evolved and about current practices in manufacturing.
  • Learn from case studies how the technology has been used to improve manufacturing performance.

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Tuesday, April 21st, 2020

Digitalization means a more productive and adaptive plant through the application of analytics to leverage connectivity and data - maximizing efficiency from people, processes, equipment and core systems. How? By facilitating data driven decisions. Raman spectroscopy enables real-time compositional analysis for in-process control making it a rich data source to drive process efficiency and optimization.

Kaiser's latest Raman analyzers with embedded controls embrace digitalization and take a proactive approach to transition spectroscopy platforms to Industry 4.0 standards. Raman Rxn™ embedded analyzers improve connectivity, reliability and scalability in the age of IIoT. This has been demonstrated by the biopharmaceutical industry utilizing Raman-based analytics to ensure product and process consistency, save time and resources, and improve bioprocess efficiency. In this webinar, we will present advances in IIoT-ready Raman technology and application examples from the biopharmaceutical industry.

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Tuesday, April 21st, 2020

Adherent and suspension bioreactors for viral vector manufacturing are evolving. However, for each choice, a robust manufacturing process is critical to ensure it is scalable for these novel therapies to reach the patients.

One of the first steps in designing a process is whether to use adherent or suspension cell cultures. Each modality has its advantages and disadvantages. In this webinar, the panelists will outline key considerations in choosing the right technology and some of the pitfalls that must be overcome to ensure success at large scale.

Participants will learn:

  • What factors to consider when choosing your cell culture
  • The advantages and pitfalls with each type of culture
  • The bioreactor choices available to support each type of culture

Learn More

96-Well Plate: A Streamlined Format for Cell Culture Monitoring with Cedex Bio HT Analyzer

On Demand

A myriad of factors are decisive in the development of successful cell culture upstream processes. Efficiency in testing and evaluating these parameters is a key consideration for setups and workflows that is often solved through robotics in different fields. The ultimate goal for modern cell culture upstream processes is a fully automated system for the repeated, controlled and preferably hands-off monitoring of multiple concurrent processes, from sample collection through data analysis and resulting feedback loops.

At Roche Pharma Cell Culture Research, highly parallelized bioprocessing using microscale bioreactors (bioreactor farms) enabled such high-throughput efficiency but called for an innovative solution to capture and analyze data from multiple, concurrently running fermenters.

Join this webinar to 

  • See the Roche set-up for high throughput sample testing in action
  • Learn about the efficient workflow with a pipetting robot, the recently integrated 96 well plate and smart data processing

Learn More

Tuesday, May 12th, 2020

In consideration of public health measures being taken by us and our customers, Asahi Kasei Bioprocess America, Inc. is offering the Planova Operators Course via Skype. 

This training course will be held live for active participation and questions. We'll provide the classroom and in-lab demonstrations by an operator in real time, as we teach and show virus removal methods. Discussion will be interactive.

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Tuesday, April 21st

Adherent and suspension bioreactors for viral vector manufacturing are evolving. However, for each choice, a robust manufacturing process is critical to ensure it is scalable for these novel therapies to reach the patients.

One of the first steps in designing a process is whether to use adherent or suspension cell cultures. Each modality has its advantages and disadvantages. In this webinar, the panelists will outline key considerations in choosing the right technology and some of the pitfalls that must be overcome to ensure success at large scale.

Participants will learn:

  • What factors to consider when choosing your cell culture
  • The advantages and pitfalls with each type of culture
  • The bioreactor choices available to support each type of culture

Learn More

On Demand

A myriad of factors are decisive in the development of successful cell culture upstream processes. Efficiency in testing and evaluating these parameters is a key consideration for setups and workflows that is often solved through robotics in different fields. The ultimate goal for modern cell culture upstream processes is a fully automated system for the repeated, controlled and preferably hands-off monitoring of multiple concurrent processes, from sample collection through data analysis and resulting feedback loops. 

At Roche Pharma Cell Culture Research, highly parallelized bioprocessing using microscale bioreactors (bioreactor farms) enabled such high-throughput efficiency but called for an innovative solution to capture and analyze data from multiple, concurrently running fermenters.

Join this webinar to:

  • See the Roche set-up for high throughput sample testing in action

  • Learn about the efficient workflow with a pipetting robot, the recently integrated 96 well plate and smart data processing

Learn More

Wednesday, April 29th, 2020

As industry 4.0 principles are applied to and adopted in the biotech environment - also known as Bioprocessing 4.0 - the convergence of various disciplines such as advanced bioprocessing technologies with software, automation and analytics is crucial.  Using a convergent toolbox of digitally-connected, intensified and continuous technologies will allow for reduced costs with increased quality, flexibility, and speed.

Reserve your virtual seat today and learn how our new suite of software, specifically conceived by bioprocess engineers for bioprocess engineers, will provide you with enhanced process control, data and process analytics, faster decision-making and a deep and insightful understanding of your bioprocess.

Learn More

Tuesday, May 5th, 2020

Filter integrity test values are part of the batch protocol and are used to justify the drug release. Long term reliable data is therefore crucial to avoid quality deviations and potential 483 warning letters. Devastating malware incidents and the continuing threat of computer viruses have created an urgent need for data protection and security. Join this webinar to learn more about how the Sartocheck 5 Plus can help you reach the ultimate level of Data Integrity.

Key Objectives:

  • Get full understanding of the importance of data integrity and data security related to filter integrity test results
  • Get an insight on how the Sartocheck®5 Plus Filter Tester has been designed for inherent resistance against data virus and malware
  • See how the Sartocheck®5 Plus Filter Tester fulfills the ALCOA+ principles

Learn More

On Demand

For cultivation of mammalian cells in biopharmaceutical research and manufacturing, single-use technology possesses several advantages to autoclavable material. Bioreactor scalability is critical to streamlining the adaptation of culture volumes during process development and manufacturing.

In this webinar, we discuss several scaling approaches, such as constant tip speed, kLa, and power number-based scale-up. Data will be underlined with two case studies.

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Wednesday, April 1st, 2020

This webinar will examine mixed-mode chromatography for biomolecule purification. The ligand design impacts the strength and specificity of the interactions. Multiple interactions between stationary and mobile phases lead to unique selectivities and can facilitate separation of closely related proteins and contaminants.
Discussion Topics:

  • Higher resolution compared to unimodal interactions
  • Improved yield and activity
  • Large design space for protein interaction
  • Minimal feed manipulation prior to binding
  • Mild operating conditions preserve activity

Learn More

On Demand

For cultivation of mammalian cells in biopharmaceutical research and manufacturing, single-use technology possesses several advantages to autoclavable material. Bioreactor scalability is critical to streamlining the adaptation of culture volumes during process development and manufacturing.

In this webinar, we discuss several scaling approaches, such as constant tip speed, kLa, and power number-based scale-up. Data will be underlined with two case studies.

Learn More

July 20th - July 30th, 2020

Presented by G-CON Manufacturing and Vanrx Pharmasystems

What if isolator filling lines were ordered fully integrated, fully qualified, installed in their fully integrated and qualified surrounding classified environment, all with guaranteed functionality? Well, this need has become a reality. Come see the first and only turnkey facility for aseptic filling of advanced therapies, Microcell POD.

Attendees will have the opportunity to:

- Discuss the paradigm shift in biopharma filling solutions
- Learn the features and benefits of Microcell POD
- Speak with G-CON and Vanrx sales and engineering  experts
- Tour a live example of the Microcell POD

Learn More

Wednesday, June 3rd, 2020

Presented by Dan Hill, Manufacturing Scientist at Biogen

The use of in-line Raman spectroscopy as an in-line process analytical technology (PAT), in the biotechnology industry, has matured over the past decade from a technology with promise to a standard tool for real-time, continuous monitoring of cell culture processes. There is an ever-growing body of work demonstrating successful application from metabolite and product quality monitoring to process control in both process development and GMP manufacturing environments.

This presentation will describe Biogen's past efforts and strategic direction as it relates to in-line Raman spectroscopy for cell culture operations and how we intend to leverage its capability beyond metabolite monitoring and glucose feedback control to become an essential element of our Advanced Process Control efforts.

Learn More

Wednesday, November 11th, 2020

The joint UMass Lowell & YMC ChromaCon course hands-on training related to multicolumn chromatography operation and theory with support from MilliporeSigma will include training on continuous downstream processing. 

The course will include discussions on design of continuous capture and polish processes, validation, process economy and operational excellence. Training will take place at UMass and will include practical lab work including experimental design and execution of continuous capture chromatography. 

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Tuesday, March 24th, 2020

KinetiSol® is a high-energy, fusion-based solubility enhancement technology that is used to generate pharmaceutical amorphous solid dispersions (ASDs) without the assistance of solvent and often below the melting point of the active pharmaceutical ingredient (API). 

Kaiser Raman spectroscopy is being used as an at-line process analytical technology (PAT) for polymorphic content analysis of KinetiSol®-generated ASDs. Crystalline content is analyzed using a Kaiser Raman 785nm analyzer with a PhAT probe immediately upon ejection of the shots from KinetiSol® compounders, eliminating the time constraints of off-line powder X-ray diffraction (XRD) analysis. Spectral features reflecting the polymorphic content of the shots have been analyzed using multivariate techniques such as partial least squares regression (PLSR) analysis and support vector machines (SVM) classification. 

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Thursday, March 19th, 2020

Complex fluids such as liposomes are increasingly being used as a vehicle for drug delivery, but due to their nature, efficient and large-scale manufacturing can be challenging. One such challenge is sterile filtration, both from a throughput and bacterial retention standpoint. 

Producing liposomes with precisely controlled particle size and distribution ensures an efficient downstream sterile filtration process. To overcome sterile filtration challenges appropriate decisions must be made during the selection, evaluation, and validation of filters intended for the sterilization of liposome-based drugs.

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Monday, March 23rd, 2020

Get it right from the start with Design of Experiments (DOE)! As anyone in product development knows, getting things right from the start is a challenge. Especially with many parameters to take into account. For industries like Pharma and Biopharma where outcomes are critical and the competition is fierce, you need tools that you can be sure will get you to the market on time; design of experiments (DOE) is indispensable in this context.

Join this webinar and discover what DOE is and what makes it so useful. Learn about the fundamental uses of DOE (screening, optimization and robustness testing) and how these applications can generate value from your data. 

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Thursday, March 19th 2020

Complex fluids such as liposomes are increasingly being used as a vehicle for drug delivery, but due to their nature, efficient and large-scale manufacturing can be challenging. One such challenge is sterile filtration, both from a throughput and bacterial retention standpoint.

Producing liposomes with precisely controlled particle size and distribution ensures an efficient downstream sterile filtration process. To overcome sterile filtration challenges appropriate decisions must be made during the selection, evaluation, and validation of filters intended for the sterilization of liposome-based drugs.

Learn More

Thursday, May 28th, 2020

UMass Lowell

Hosted by UMass Lowell, YMC / ChromaCon - The joint UMass Lowell & YMC ChromaCon course hands-on training related to multi-column chromatography operation and theory will include instruction on continuous chromatographic processing. The course will focus the design of continuous capture and polishing processes, validation, process economy and operational excellence with special emphasis on techniques to purify peptides, oligos, ADC's and isoforms. Training will take place at UMass and will include practical lab work including experimental design and execution of continuous capture chromatography.

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Tuesday, March 24th, 2020

10:00 AM EST

KinetiSol® is a high-energy, fusion-based solubility enhancement technology that is used to generate pharmaceutical amorphous solid dispersions (ASDs) without the assistance of solvent and often below the melting point of the active pharmaceutical ingredient (API). Kaiser Raman spectroscopy is being used as an at-line process analytical technology (PAT) for polymorphic content analysis of KinetiSol®-generated ASDs. Crystalline content is analyzed using a Kaiser Raman 785nm analyzer with a PhAT probe immediately upon ejection of the shots from KinetiSol® compounders, eliminating the time constraints of off-line powder X-ray diffraction (XRD) analysis.

Learn More

April 19th - 24th, 2020 

Albufeira, Portugal

The first ECI Conference on Microbial Engineering in March 2018 in Santa Fe, New Mexico brought together leaders in Synthetic Biology, Metabolic Engineering and Fermentation Technology both from industry and the academic community. Examples of applications included natural products, therapeutic proteins, vaccines and biosynthesis of a great variety of organic chemicals.

Learn More