Event Alert

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.

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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. 

Learn More

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. 

Learn More

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.

Learn More

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

Friday, April 3rd - Tuesday, April 21st, 2020

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

Thursday, June 18th, 2020

Hotel Royal Sonesta, Cambridge, MA

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, systems, and components suppliers work together. The Levitronix Bioprocessing Conference brings industry professionals together to make a change.

Learn More

Presented by ECI

April 19th - 24th, 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.  Based on the success of this meeting we plan to hold a second ECI Conference "Microbial Engineering II" in Albufeira, Portugal.  We are confident that this will capture the exciting progress being made on many fronts and highlight practical applications.

Learn More

Live Webinar

Presented by Dr. Derek C. Lenz, Beckman Coulter

Wednesday, March 11th, 2020

The tale of Goldilocks is as timeless, informative and relevant to biopharma, as it is generally for society.

Specifically, as it pertains to culturing cells, lessons conveyed by this fairy tale are both obvious and subtle; media composition, ambient conditions and other key parameters must be maintained within specific ranges for production of robust cells and sub-cellular products.

However, optimising those very conditions serve to create a negative feedback loop, as the cells perturb the balance of healthy culture conditions through normal in vitro metabolic processes. In many cases, the negative variance can quickly become irreversible and fatal to the cell culture. Thus, accurate, repeatable and verifiable analytical instruments and processes are required to maintain an appropriate Biological Goldilocks Zone.

Learn More

Live Webinar

Thursday, February 13th, 2020

Viral vectors for gene therapy have shown tremendous clinical promise which has spurred a huge increase in demand for manufacturing space, resulting in a capacity crisis. This is currently delaying the commercialization of these gene therapies for which time to market is critical.

Integrated solutions for viral vectors designed within modular cleanroom facilities streamline manufacturing and reduce time to market. Pall Biotech and G-CON manufacturing have partnered to design and deploy an integrated manufacturing solution to address the current capacity constraints for viral vector manufacturing.
Participants will learn: 

  • The manufacturing challenges facing the viral vector industry
  • The advantages of an integrated manufacturing solution
  • How to develop and deploy a new manufacturing facility in 10 months within a modular cleanroom 

Learn More

Online Product Launch

Wednesday, February 12th, 2020

Join us when we unveil the latest family member of the Eppendorf Bioprocess product family: Our next-generation bioprocess controller. Curious? Join one of the two sessions

9 AM CET / 4 PM CST
5 PM CET / 8 AM PST / 11 AM EST

The online event will take approximately 60 minutes. During the event, we will introduce our brand-new bioprocess controller and you will have the opportunity to see and learn more about it in the virtual showroom. You will be able to log in 15 minutes before the official start and are welcome to explore the virtual conference area, before joining us in the auditorium.

Learn More

On-Demand Webinar

Accumulation of CO2 in fermentation and cell cultures can become a significant problem affecting productivity and product quality of recombinant proteins and monoclonal antibodies (mAbs). During this webinar, the following topics will be approached with a technical perspective:

  • Measuring CO2 inline and monitor its accumulation
  • Elevated CO2 partial pressure (pCO2) can alter protein glycosylation and affects the purity of mAbs
  • pCO2 is affecting media and intracellular osmolality
  • Measuring pCO2 offline versus inline
  • Monitoring and controlling CO2 during a fermentation

A list of scientific references for fermentation and cell culture processes will be also communicated and available after the webinar.

Learn More

Friday, April 3rd - Tuesday, April 21st, 2020

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, February 12th, 2020

Join us when we unveil the latest family member of the Eppendorf Bioprocess product family: Our next-generation bioprocess controller. Curious? Join one of the two sessions


9 AM CET / 4 PM CST
5 PM CET / 8 AM PST / 11 AM EST

The online event will take approximately 60 minutes. During the event, we will introduce our brand-new bioprocess controller and you will have the opportunity to see and learn more about it in the virtual showroom. You will be able to log in 15 minutes before the official start and are welcome to explore the virtual conference area, before joining us in the auditorium. 

We're looking forward to meeting you at our online conference!

Learn More

Wednesday, January 29th, 2020

This webinar will discuss the system requirements for immunoglobulin and albumin within existing commercial processes regarding automation, process & product safety, piping diameters and system volume. Secondly the requirements for the filter cassettes is under focus and several aspects will be covered such as membrane choice, screen selection and the determination of the required membrane area. 

Then an overview of the critical process parameters for immunoglobulin and albumin such as recirculation rate, inlet/outlet pressure, flux rates and other relevant parameters will be given. For each process parameter the typical operating ranges will be given which are considered to give a high-quality process.

In the last part of the webinar a few case studies are shown where the performance of PESU based membranes are compared against cellulose based membranes. The productivity of both membranes will be compared for immunoglobulin and albumin based on user data.

Learn More

Presented by Ben Jeyaretnam, E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager at SGS Group

On Demand

The biopharma industry has been increasingly using single use systems (SUS) for bioprocessing and storage of intermediate and final bulk material in addition to primary packaging. Before a SUS could be used in the manufacturing process, it needs to be qualified for use by a pre-determined process. This presentation will discuss a variety of challenges, both internal and external to the industry that the end use faces during the qualification process. Complexity of SUS, varying quality of vendor data, component change management, changing regulatory expectations, analytical data generation, logistical challenges during E&L study execution, analytical challenges, and the potential impact of unexpected E&L study results will be presented.

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Presented by Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D'Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific

On Demand

Extractable and Leachable (E&L) studies on materials used in the manufacturing process and container closer systems of drug products and drug substances are commonly used to assess the risk for patient exposure. Most often LC-MS or GC-MS is used to detect, identify and then quantify extractables and leachables. In general, an analytical evaluation threshold or reporting threshold is set based on a calculated patient exposure. Substances above the set threshold required further investigation if patient exposure exceeds this. In this webinar we will discuss an approach for different levels of identification and how to increase the level of confidence of identified extractables and leachables.

Learn More

Wednesday, January 29th, 2020

This webinar will discuss the system requirements for immunoglobulin and albumin within existing commercial processes regarding automation, process & product safety, piping diameters and system volume. Secondly the requirements for the filter cassettes is under focus and several aspects will be covered such as membrane choice, screen selection and the determination of the required membrane area. In the last part of the webinar a few case studies are shown where the performance of PESU based membranes are compared against cellulose based membranes. The productivity of both membranes will be compared for immunoglobulin and albumin based on user data.

Learn More

Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen

On-Demand

Biogen is adopting modeling maturity models similar to the ones used by high tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial particularly when implementing data driven models that rely on process experience. A well-planned modeling continuum should allow the pharmaceutical industry to realize the benefits from modeling activities early on, while evolving into more mature prescriptive controllers.

Learn More

Wednesday, January 29th, 2020

This webinar will discuss the system requirements for immunoglobulin and albumin within existing commercial processes regarding automation, process & product safety, piping diameters and system volume. Secondly the requirements for the filter cassettes is under focus and several aspects will be covered such as membrane choice, screen selection and the determination of the required membrane area.

In the last part of the webinar a few case studies are shown where the performance of PESU based membranes are compared against cellulose based membranes. The productivity of both membranes will be compared for immunoglobulin and albumin based on user data.

Learn More

On Demand
Presented by Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology, Technical Operations at Janssen Pharmaceuticals


The presentation shares the journey that Janssen is taking as it progresses its strategy on Advanced Process Control (APC). Within Janssen we aspire to improve our Manufacturing Technology Organization's performance on key metrics such as cost of goods, on time and in full product delivery, production cycle time, and right first-time. Improving these metrics require a comprehensive technology strategy that addresses all the metrics together. Janssen' s strategy has three pillars. 1: process intensification, 2: modular and flexible designs, and 3: process digitalization and advanced process control. Each pillar contributes differently to the key metrics but in aggregate make it possible to reach our goals.
Learn More

On Demand

Presented by Akunna Iheanacho, PhD, Director of Research and Development at Texcell and Xuemei He, PhD, R&D Manager, Chromatograpy Media Chemistry at Bio-Rad Laboratories

Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development. In this case study, we utilize a DOE approach to investigate the effect of buffer pH and conductivity on the removal of various product- and process-related impurities, including the minute virus of mice (MVM), by a mixed-mode chromatography resin, Nuvia aPrime 4A. 
Results from this study have offered insights on the interactions between the resin and MVM particles and the design space for the removal of this virus. Practical considerations for developing a mixed-mode chromatography process with effective overall impurity clearance will also be discussed in this webinar. 
Learn More

Thursday, December 19th, 2019

Presented by: Dr. Ir. Robert Mans - Delft University of Technology (TU Delft)

Evolutionary engineering of microbes provides a powerful tool for untargeted optimization of (engineered) cell factories and identification of genetic targets for further research. Directed evolution is an intrinsically time-intensive effort and automated methods can significantly reduce manual labor. Those automated methods can be used to evolve yeast cultures for more than 1,000 generations and are designed to require minimal manual intervention.

Register and learn more about:

  • Introduction into why and when to use evolutionary engineering for microbial strain optimization
  • Experimental design considerations for various automated evolutionary engineering cultivation methods
  • Overview of recently developed generic workflows and control software for batch, chemostat and accelerostat based evolution in automated bioreactors

Learn More

On Demand

Post-approval changes (PAC), especially for vaccines and therapeutic proteins, have been hindered by different regional regulatory requirements and a conservative industry mindset. Manufacturing science and technology (MSAT) experts within our company have leveraged their knowledge to support an industry shift towards innovation and continuous improvement. Collaborations with drug manufacturers over the years have built our knowledge to understand the unit operations of drug manufacturing correlated with risk. In addition, many small-scale models at our company, aligned with current regulations, have been utilized to support these risk assessments.

In this webinar, you will learn:

  • An understanding of the real regulatory constraints and intents
  • Guidance and case studies that will help clarify critical factors for decision making
  • Detailing conditions to be fulfilled and supporting documentation needed for specific cases

Learn More

Thursday, December 5th, 2019

Product life cycle normally consists of 3 phases: Process Design, Process Performance Qualification and the last and the lengthiest Continued Process Verification (CPV) which goes throughout the lifespan of the product. CPV has become a part of the observations in recent warning letters of regulators either due to lack of complete understanding of the concept, or lack of right tools to perform CPV in an efficient way.

In this webinar, you will learn:

  • Strategy and all associated components required to establish a compliant and efficient continued process verification (CPV) program within your organization.

Learn More

Wednesday, December 4th, 2019

MolMed is a biotechnology company focused on research, development and manufacturing of innovative therapies to treat cancer and rare genetic diseases.  MolMed has developed a robust and scalable process for the industrial scale production of both LV and RV vectors for use in gene-modified cell therapy using the iCELLis® bioreactor platforms.  In this webinar, Molmed will present the development and optimization of their LV and RV vector production processes.

Don't miss this detailed case study from Giuliana Vallanti, PhD at MolMed and Clive Glover, PhD at Pall Biotech followed by a live Q&A

Learn More

Tuesday, December 3rd, 2019

Viral vector-based vaccines are a promising field in vaccinology and are taking more importance in the overall vaccine pipeline. They elicit a strong immune response in patients, avoid the use of highly pathogenic viruses - such as Ebola - and most important are "platform-able". However, viruses are complex entities to produce and purify. The downstream process should be able to remove process and product related contaminants while maintaining the infectious titer, which is a challenge.

In this webinar, Amélie Boulais will describe how the first high throughput ambr® multi parallel testing tool applied to downstream and the Design of Experiment software can simplify and accelerate viral vector purification process development. A case study on an Adenovirus at a 20L scale will show how membrane chromatography and large-cut off cross-flow cassettes can further simplify and intensify the purification process of common viral vectors used for vaccines.

Key Learning Objectives

  • Understand solutions to intensify viral vector purification
  • Discover tools to speed-up process development
  • Configure single-use process scale equipment for viral vectors purification
  • Learn how data analytics can be used for predictive control

Learn More

On Demand

Post-approval changes (PAC), especially for vaccines and therapeutic proteins, have been hindered by different regional regulatory requirements and a conservative industry mindset. Manufacturing science and technology (MSAT) experts within our company have leveraged their knowledge to support an industry shift towards innovation and continuous improvement. Collaborations with drug manufacturers over the years have built our knowledge to understand the unit operations of drug manufacturing correlated with risk. In addition, many small-scale models at our company, aligned with current regulations, have been utilized to support these risk assessments.

Against common assumptions, many of the manufacturing system and raw material changes that are typically considered major, could be categorized as moderate and minor changes. During this presentation, PAC case studies based on selected collaborations will be presented, highlighting a science and risk-based approach to foster effective manufacturing changes and improvements.

Learn More

Wednesday, November 27th, 2019

Single-use (SU) technology is without question one of the key technologies for the development of the biopharmaceutical industry and the manufacturing of drug products. SU equipment is used especially for scalable application such as the production of vaccines, CAR T cells, monoclonal antibodies (mAb), or the manufacturing of biosimilars. One of the main concerns over the last decades continues to be extractables from SUS which potentially are released into the process solutions as process equipment-related leachables (PERLs). In this context, the assessment of extractables is required for the process qualification.

The webinar focuses on the strategy developed by Sartorius Stedim Biotech (SSB) to provide the most detailed extractables data enabling our customers to implement rapidly and cost-effectively SU equipment into bioprocessing applications. The analytical and component approach is presented. Scaling exercises and the toxicological evaluation is exemplified using data of the current SSB Extractable Guide of a widely-used sterile filter of the Sartopore® family.

Learn More

Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia

Tuesday, November 26th, 2019

The complexity of biotherapeutic products and their manufacturing processes can yield a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. These impurities can be broadly grouped into two categories: The first, product-related impurities, such as precursors, aggregates and degradation products, and the second, process-related impurities, such as host cell DNA, host cell protein, and particulates.  This presentation will provide an overview of different approaches for monitoring impurities, including a discussion of existing USP standards and standards under development to support impurity testing.

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Wednesday, November 20th, 2019

Data Analytics is one of the key trends within the pharmaceutical industry, both for the production of 'classical' drugs as well as large molecules. Companies are looking for ways to shift from the traditional way of operations to a more smart and optimal approach. The main advantages associated with such processes are more room for modularity, automation, and flexibility due to a smaller footprint, but also a more consistent quality of the drug product. The regulatory bodies see the promise of these processes and actively promote companies to implement this manufacturing strategy. This is illustrated by the recently published draft guidelines from the FDA for the production of small molecule drugs using continuous processes and the active discussion with the (bio)pharmaceutical industry through their Emerging Technology Program.

The amount of data and information generated in continuous and batch processing creates new opportunities to expand the use of multivariate process modeling. This webinar will cover and expand upon the MVDA and DOE offerings of Sartorius as a part of the Umetrics Suite while covering different modes of implementation, advantages and talk about why data analytics is now a cardinal need of the industry.

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Presented by: Dr. Ir. Robert Mans - Delft University of Technology (TU Delft)

Thursday, December 19th, 2019

Evolutionary engineering of microbes provides a powerful tool for untargeted optimization of (engineered) cell factories and identification of genetic targets for further research. Directed evolution is an intrinsically time-intensive effort and automated methods can significantly reduce manual labor. Those automated methods can be used to evolve yeast cultures for >1,000 generations and are designed to require minimal manual intervention.

Topics:

  • Introduction into why and when to use evolutionary engineering for microbial strain optimization
  • Experimental design considerations for various automated evolutionary engineering cultivation methods
  • Overview of recently developed generic workflows and control software for batch, chemostat and accelerostat based evolution in automated bioreactors

Learn More

Wednesday, November 27th, 2019

Single-use (SU) technology is without question one of the key technologies for the development of the biopharmaceutical industry and the manufacturing of drug products. SU equipment is used especially for scalable application such as the production of vaccines, CAR T cells, monoclonal antibodies (mAb), or the manufacturing of biosimilars. One of the main concerns over the last decades continues to be extractables from SUS which potentially are released into the process solutions as process equipment-related leachables (PERLs). In this context, the assessment of extractables is required for the process qualification.

The webinar focuses on the strategy developed by Sartorius Stedim Biotech (SSB) to provide the most detailed extractables data enabling our customers to implement rapidly and cost-effectively SU equipment into bioprocessing applications. The analytical and component approach is presented. Scaling exercises and the toxicological evaluation is exemplified using data of the current SSB Extractable Guide of a widely-used sterile filter of the Sartopore® family.

Learn More

Tuesday, November 12th, 2019

Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development. In this case study, we utilize a DOE approach to investigate the effect of buffer pH and conductivity on the removal of various product- and process-related impurities, including the minute virus of mice (MVM), by a mixed-mode chromatography resin, Nuvia aPrime 4A. Results from this study have offered insights on the interactions between the resin and MVM particles and the design space for the removal of this virus. Practical considerations for developing a mixed-mode chromatography process with effective overall impurity clearance will also be discussed in this webinar.

Learn More

Tuesday, November 26th, 2019

Until recently, the European pharmaceutical industry could only produce WFI via distillation. That all changed in April 2017 when the European Pharmacopeia revised monograph 0169 to allow WFI production through the cold process of reverse osmosis (RO). While RO-based systems can offer benefits like lower operating costs, they also pose extra challenges.

In this live 45-minute webinar you'll learn:

  • The benefits of producing WFI through RO-based systems
  • The challenges of RO-based systems and how you can overcome these
  • How the costs, risks and sustainability of RO-based systems compare to other WFI production methods
  • Whether Cold WFI is a good fit for your facility

You'll have the chance to ask questions, and after the webinar you'll receive a recording to watch again in your own time.

Learn More

- Dan Hill, Manufacturing Scientist, Biogen

Available On Demand

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 is due, in part, to advances in technology robustness, user- and integration-interfaces, improved sensitivity, and fluorescence rejection. Organizations are now faced with the difficult task of best leveraging these tools and extracting the most value from them. Thus, defining and executing Raman program strategy is critical to the technology's long-term success and sustainability.

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 27th, 2019

Single-use (SU) technology is without question one of the key technologies for the development of the biopharmaceutical industry and the manufacturing of drug products. SU equipment is used especially for scalable application such as the production of vaccines, CAR T cells, monoclonal antibodies (mAb), or the manufacturing of biosimilars. One of the main concerns over the last decades continues to be extractables from SUS which potentially are released into the process solutions as process equipment-related leachables (PERLs). In this context, the assessment of extractables is required for the process qualification.

The webinar focuses on the strategy developed by Sartorius Stedim Biotech (SSB) to provide the most detailed extractables data enabling our customers to implement rapidly and cost-effectively SU equipment into bioprocessing applications. The analytical and component approach is presented. Scaling exercises and the toxicological evaluation is exemplified using data of the current SSB Extractable Guide of a widely-used sterile filter of the Sartopore® family.

Learn More

Wednesday, November 13th, 2019

Nowadays the implementation of scale-down methods for screening and optimization are essential in the developments of new therapies. In this regard, the use of a micro-bioreactor platform is a powerful tool for scaling of the culture conditions. Besides, the individual measurement and control of pH, dissolved oxygen and temperature offer an advantage compared to the traditional 24 standard round well plate that has been widely used for the cultivation mammalian cell lines.

Topics:

  • Screening of growing conditions for CHO cells
  • Scale translation of CHO cell cultivation from 10 mL (micro-Matrix) to 5L stirred tank bioreactor
  • Rapid optimization of Fed-batch using micro-Matrix

Learn More

November 21st, 2019 - Lisbon, Portugal

The Stem Cell Community Day connects researchers from all over the world to discuss recent advances in the stem cells field, with a special focus on controlled cultivation in stirred-tank bioreactors. Stem cell-based technologies lay the basis for pioneering approaches in regenerative medicine, drug screening, and toxicology testing. Their commercial use requires reliable methods for the large-scale production of stem cells in consistent quality.

At our 3rd Stem Cell Community Day, we will again bring together experts from industry and academia to discuss recent achievements, challenges, and chances in stem cell bioprocessing for research and commercial manufacturing.

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On Demand

Like petroleum, steel, automobile and consumer goods several decades ago, the biopharmaceutical industry is currently considering a wider implementation of continuous processing as part of a global process intensification objective. Continuous processing is already well accepted on the upstream processing side, since perfusion mode culture has been in use for decades at an industrial scale. Justifications for switching from batch to continuous chromatography are numerous.

Besides, the rising demand of biologics suggests reduced processing and labor costs, footprint reduction, flexibility increase, more stringent requirements for controlled, more consistent and improved quality; and most importantly, the requirement for higher productivity and therefore overall manufacturing cost reduction. Last but not least regulators are pushing for continuous processing.

Learn More

On Demand

Mass spectrometry (MS) is a common technique used daily in the analytical laboratory. The information provided by mass spectrometry is of value in a variety of assays across multiple application areas.

In this series of webinars, we will review the concepts of mass spectrometry. The first seminar of the series will focus on the ionization techniques commonly used today and some characteristics of ion source design. The second webinar will spotlight and compare the most commonly used MS analyzers and detectors. The final webinar will review some advanced techniques in mass spectrometry, namely ion mobility and MS imaging, techniques that are coming to the fore at the present time. Throughout the webinar series, practical examples and tips will be shared so that new users of the technique will gain insights that can be put to immediate use.

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Wednesday, November 6th, 2019

Eppendorf invites you to be our guest at a complimentary bioprocess workshop where attendees will benefit as we present and discuss information on Implementation of an Affordable and Scalable Manufacturing Strategy for Gene Therapy as well as A Beginner's Guide to Bioprocess Modes - Batch, Fed-Batch, and Continuous Processing. You will also learn about scalable processes using Raman-based control strategies presented by Kaiser.

Eppendorf's integrated portfolio of bioprocess systems, software and consumables will be on hand for demonstration including the DASbox® Mini Bioreactor System, the BioFlo® 120 and BioFlo® 320 Controllers, as well as our full line of Single-use Vessels.

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Tuesday, November 5th, 2019

The International Committee for Harmonization issued their recommendations on validating an analytical instrument, ICH Q2, to support users of analytical equipment such as Total Organic Carbon (TOC) analyzers. It covers all the important aspects of validating an analyzer, including ensuring that it is suitable for the test conditions of the application and the random effects on intermediate precision caused when different technicians perform the same test, i.e. human error.

This webinar explains the different aspects of ICH Q2 and how they apply to TOC analyzers used in pharmaceutical applications.

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On Demand

Accurate and reliable analytics are crucial in the development and manufacturing of viral-based drugs. In this webcast key concepts and strategies will be discussed how to apply analytical information to the development of these emerging therapies. The discussion will include the following topics:

  • Applying the mix of analytical methods that reveal process impact on critical quality attributes
  • How meaningful analytical data can be critical for reducing process development time or root-cause analysis in manufacturing processes
  • The need for innovation in analytics and how artificial intelligence can play a role

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Tuesday, October 29th, 2019

The digital transformation of laboratories brings many advantages but also new challenges for the laboratory staff. Ensuring the integrity of data and the seamless integration of laboratory instruments into the IT landscape are two major challenges.

Join this webcast to learn how to fulfill data integrity in the paperless lab with an intelligent instrument design.

Key Learning Objectives:

  • Review why data integrity has become a hot topic in laboratories
  • Understand the problems to integrate instruments into a laboratory environment
  • Learn what is needed to document instrument results paperless under the aspects of data integrity

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Wednesday, November 13th, 2019

Nowadays the implementation of scale-down methods for screening and optimization are essential in the developments of new therapies. In this regard, the use of a micro-bioreactor platform is a powerful tool for scaling of the culture conditions. Besides, the individual measurement and control of pH, dissolved oxygen and temperature offer an advantage compared to the traditional 24 standard round well plate that has been widely used for the cultivation mammalian cell lines.

Topics to be covered:

  • Screening of growing conditions for CHO cells
  • Scale translation of CHO cell cultivation from 10 mL (micro-Matrix) to 5L stirred tank bioreactor
  • Rapid optimization of Fed-batch using micro-Matrix

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Bag Assemblies for Freeze/Ship/Thaw Processes

In this recorded webinar, Janelle Rupkalvis from Entegris and Alex Kakad from New Age Industries, discuss the needs and changing requirements of standard equipment and processes to handle lower temperatures by considering:

  • Limitations of current technologies
  • Innovative system solutions
  • Advanced materials

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Wednesday, October 23rd, 2019

With the expansion of single-use systems in all process steps of commercial manufacturing, integrity failure can significantly affect drug safety, availability and costs. As a result, industry scrutiny on single-use system integrity (SUSI) is increasing, raising the need to develop a good science behind fluid leakage and microbial ingress, as well as appropriate physical integrity testing technologies.

This webinar will focus on how applying good science help determine the maximum allowable leakage limit (MALL) under which no product leakage and no bacteria ingress occur with SUS under various fluids and process conditions. The understanding of liquid leakage and bacteria ingress mechanisms also enables to validate robust liquid leak and microbial aerosol challenge tests that both are correlated to the detection limits of physical integrity testing methods.

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Thursday, October 24th, 2019

Developers of cell and gene therapies continue to lead advancements and provide life-saving treatments to many patients.  Critical parts of the development process are the biosafety and characterization tests of the cell and viral products. These vital analytical methods mitigate safety concerns and improve the understanding of the product and process well in advance of patient administration.

In this webinar, we will introduce phase-appropriate validation and discuss why it may be advantageous for cell and gene therapy development. In addition, we will discuss what factors you should consider when evaluating your validation strategy and describe how our validated platform assays can help you meet your critical development timelines.

Looking specifically at potency and infectivity assays as a case study, we will walk through the evaluation process and validation requirements.

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Tuesday, October 29th, 2019

Industrial Transformation (IX) is one of the most important trends in today's industrial corporations. Two-thirds of companies have already or are actively planning on embarking on an IX journey. Life Science manufacturers are behind with companies planning longer IX journeys, fewer companies progressing deeply into their IX journey and still fewer companies becoming "IX Leaders". In this webinar, we will review the findings from LNS Research's recent global survey to identify the best practices and life lessons in IX.

Adopting the key learnings from IX Leaders -- around team structure, the potential to Operational Technologies and expanding the focus of IX Programs among many others - will help Life Science manufacturers dramatically improve the success rate and business impact of their IX programs.

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Thursday, October 24th, 2019

Accumulation of CO2 in fermentation and cell cultures can become a significant problem affecting productivity and product quality of recombinant proteins and monoclonal antibodies (mAbs). During this webinar, the following topics will be approached with a technical perspective:

  • Measuring CO2 inline and monitor its accumulation
  • Elevated CO2 partial pressure (pCO2) can alter protein glycosylation and affects the purity of mAbs.
  • pCO2 is affecting media and intracellular osmolality
  • Measuring pCO2 offline versus inline
  • Monitoring and controlling CO2 during a fermentation

A list of scientific references for fermentation and cell culture processes will be also communicated and available after the webinar.

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Tuesday, October 22nd, 2019

Rapid advancements in cell and gene therapy development have resulted in recent product approvals bringing these transformative medicines to market. Commercializing these products have introduced a new set of challenges unique to our industry.

Single-Use products and systems have proven to enable a more flexible and cost-effective approach to traditional bio-pharma manufacturing when certain manufacturing modifications are adopted. For example, using low volume sample management systems to increase product yields and implementing ready to use sterilized solution prefilled to certain amount for addition to each step in a closed loop fashion. These new products can be used to streamline the process with consistent quality output.

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Thursday, October 10th, 2019

Washington, D.C.

Repligen technical seminars are unique opportunities to discuss with key thought leaders and experts the changing landscape of bioprocessing around the world. Industry case studies in process intensification, continuous processing and flexible facilities allow you to learn from adopters of transformative technologies, evaluate risk landscapes and set the standards for modern bioproduction.

In 2019, major technology breakthroughs will be introduced that signal market shifts in bioprocessing.

Locations include Shanghai, Washington, D.C., San Francisco, London and Geneva.

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Monday, October 7th, 2019

As titers have gone up in cell culture, more downstream bottlenecks have emerged. Columns have become larger, buffer volumes have gone up and expenses related to Protein A columns with antibody production have sky-rocketed. Facility size and footprint have become moving targets.

  • Radial flow Chromatography columns which are employed in the manufacture of 24 FDA approved drugs can enable 4X the flow rate of conventional columns
  • Chromatography skids with 100:1 turn-down ratios can be employed across a wide range of columns enabling greater flexibility as columns sizes change

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Wednesday, October 2nd, 2019

Cambridge, MA

Intensified and continuous biomanufacturing is a hot topic in our industry as it increases productivity and efficiency. Sartorius Stedim Biotech is already offering a unique platform for both fast track development and large scale single-use intensified manufacturing, including new next generation process intensification tools for USP and DSP that have been or will be launched soon.
Join our Intensified Seminar to learn more about our platform solutions! Our process experts as well as speakers from Sanofi and Compass Therapeutics and a keynote speaker from Codiak BioSciences will talk about their experiences with new process technologies and the use of novel Bioprocess Intensification Tools.

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Wednesday, October 2nd, 2019

This live webinar will discuss the cost considerations for the application of continuous manufacturing both in operational and capital expenditures in Monoclonal antibody production. Included in this discussion will be an evaluation of the cost of production per gram between conventional fed batch and continuous processes. As well as other key considerations for adapting continuous bioprocesses specifically for the production of biosimilar MAbs.

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Thursday, September 26th, 2019

Accurate and reliable analytics are crucial in the development and manufacturing of viral-based drugs. In this webcast key concepts and strategies will be discussed how to apply analytical information to the development of these emerging therapies. The discussion will include the following topics:

  • Applying the mix of analytical methods that reveal process impact on critical quality attributes
  • How meaningful analytical data can be critical for reducing process development time or root-cause analysis in manufacturing processes
  • The need for innovation in analytics and how artificial intelligence can play a role

Learn More

Presenter: Dr. Tom Eyster, Investigator, GSK

Tuesday, September 24th, 2019

In a novel study, Raman spectroscopy was used by GSK to implement simultaneous feedback control of glucose and lactic acid in a 3L CHO bioprocess producing a monoclonal antibody (mAb). Lactic acid feeding to a setpoint of 2 g/L led to a substantially lower level of ammonium and CO2 accumulation. Additionally, from a quality standpoint, higher galactosylation of the mAb was observed with lactic acid control. Therefore, this study shows evidence that the implementation of Raman as a process control tool provides the capability to tune product quality by impacting cell metabolism. In conclusion, this work demonstrates the power of Raman spectroscopy for not only real-time process monitoring, but also implementing feedback control for product quality tuning.

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Thursday, September 19th, 2019

Large-scale downstream processing of viruses can face a range of obstacles different from those of many biotherapeutics. These challenges mostly arise from the size and complexity of the virus, which can affect product purity and recovery. Improvements of purification tools are necessary to overcome these challenges and must be engineered for easy scalability to meet manufacturing demands. Dr. Mark Snyder will discuss the difficulties when developing purification strategies for vaccine production and gene therapy. Dr. Snyder will explore innovative resin designs and functionalities and examine recent case studies and current processes that benefit from these resins and purification strategies.

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Wednesday, October 2nd, 2019

Cambridge, MA

Intensified and continuous biomanufacturing is a hot topic in our industry as it increases productivity and efficiency. Sartorius Stedim Biotech is already offering a unique platform for both fast track development and large scale single-use intensified manufacturing, including new next generation process intensification tools for USP and DSP that have been or will be launched soon.

Join our Intensified Seminar to learn more about our platform solutions! Our process experts as well as speakers from Sanofi and Compass Therapeutics and a keynote speaker from Codiak BioSciences will talk about their experiences with new process technologies and the use of novel Bioprocess Intensification Tools.

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September 16th-18th, 2019

Washington, DC

The Parenteral Drug Association (PDA) and the U.S. FDA are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, now in its 28th year. This flagship Conference consistently provides a unique opportunity to hear from and engage with numerous regulatory and industry leaders concerning the latest manufacturing, quality, supply, and compliance issues in an ever-evolving landscape.

This year's theme is Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision, and the Conference will explore the continuing development of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms. Plenary and concurrent sessions will delve into the details through the assessment of the latest innovative technologies, regulatory expectations, and forward-looking perspectives.

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Wednesday, October 2nd, 2019

Cambridge, MA

Intensified and continuous biomanufacturing is a hot topic in our industry as it increases productivity and efficiency. Sartorius Stedim Biotech is already offering a unique platform for both fast track development and large scale single-use intensified manufacturing, including new next generation process intensification tools for USP and DSP that have been or will be launched soon.

Join our Intensified Seminar to learn more about our platform solutions! Our process experts as well as speakers from Sanofi and Compass Therapeutics and a keynote speaker from Codiak BioSciences will talk about their experiences with new process technologies and the use of novel Bioprocess Intensification Tools.

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Monday, September 30th, 2019

Dublin, Ireland

Amid an undeniably rapidly evolving bioprocessing environment, driven in no small part by challenges that include integration with single-use solutions, increasingly scaled down applications, emergence of continuous processing and more, the need for access to knowledge and information is greater than ever.

Please join us for our one-day seminar by bioprocessing professionals, end users and suppliers alike, discussing the challenges associated with bioprocess optimization and the latest proven solutions being deployed to address these challenges. Speakers will include subject matter experts from our seminar partners addressing applications upstream and downstream alike. Our speakers will be sharing novel insights, case studies and taking questions on specific challenges and sharing suggested solutions.

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Tuesday, September 24th, 2019

GSK has embedded Raman spectroscopy as a key PAT tool in R&D for media composition prediction and feeding regimen control and is currently transferring Raman to clinical and commercial manufacturing sites. Our model development strategy is based on utilizing spectroscopic datasets collected with wide process variations, spiking, the use of chemometric algorithms to determine spectral regions of interest, and testing the feasibility of global and local calibrations. In a novel study, Raman spectroscopy was used to implement simultaneous feedback control of glucose and lactic acid in a 3L CHO bioprocess producing a monoclonal antibody (mAb). Lactic acid feeding to a setpoint of 2 g/L led to a substantially lower level of ammonium and CO2 accumulation. Additionally, from a quality standpoint, higher galactosylation of the mAb was observed with lactic acid control.

Presenters:

Dr. Tom Eyster, Investigator / GSK
Dr. Sameer Talwar, Senior Chemometrician / GSK

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Wednesday, September 11th, 2019

The implementation and use of single-use systems (SUS) in biopharmaceutical production is rapidly increasing and directly correlated with higher demands on Extractables and Leachables (E&L) information. Sartorius as a leader in SUS technology can look back on +20 years of experiences in the E&L area. This knowledge together with our current research initiatives enables us to progress and go beyond "simple" extractables measurement.

In this webinar, we will develop and apply methods to predict extractables and leachables. We will discuss that only an adequate physical and chemical understanding allows a correct scaling and combination of extractables data for the numerous devices and assemblies provided to the market. And we will show how mechanistic modeling, which combines sources and sinks of leachables appropriately can be used in risk assessments to quantitatively predict leachables along a process chain, in particular in intensified and continuous biopharmaceutical manufacturing.

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Thursday, August 29th, 2019

Join cell culture industry leader FUJIFILM Irvine Scientific for an informative webinar that explores several case studies demonstrating the effects of media on antibody quality:
Screening media for quality effects
Discovering factors that affect quality
Modulating galactosylation with modified feed media
Controlling galactosylation with both growth and feed media
We will also discuss the Media Survey approach and Media Development and Optimization strategies that are at the foundation of FUJIFILM Irvine Scientific's custom media collaborations with our customers.

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Available On-Demand

Stricter regulations have required biopharma companies to place even more emphasis on their regulatory compliance. Some of them use Electronic Batch Records (EBR) to report on their batch operations and to implement operational excellence programs to improve KPI's like OEE. They also monitor their processes in real-time in order to optimize the entire supply chain. These processes generate a vast amount of data. The term most pharmaceutical companies use today is Data Integrity, which is all about the data trustworthiness, data accessibility, and data quality during the entire product lifecycle. So how do you deploy a single source of truth that allows individuals to acquire this information in a fast, secure, and consistent way regardless of its origin?

In this webinar, learn how biopharma companies use the PI System to improve regulatory compliance, increase throughput, reduce time-to-market, and improve knowledge management.

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Wednesday, August 28th, 2019

Dive deeper into the topic of particulate matter risk by attending the webinar of Klaus Wormuth, Principal Scientist at Sartorius Stedim Biotech. Klaus will follow a holistic and scientific approach to show the results from Sartorius' visible particle test and extended visible particle inspection. This will outline the challenges but also point to solutions for reducing particulate matter risk in single-use systems.

The webinar will be followed by a Q&A session which will be used to gain feedback from end-users, and facilitate the discussion between suppliers and end-users based upon real rather than perceived risks.

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Tuesday, September 24th, 2019

In this highly informative webinar, GlaxoSmithKline will discuss how it has embedded Raman spectroscopy as a key PAT tool in R&D for media composition prediction and feeding regimen control and is currently transferring Raman to clinical and commercial manufacturing sites. They will explain how their model development strategy is based on utilizing spectroscopic datasets collected with wide process variations, spiking, the use of chemometric algorithms to determine spectral regions of interest, and testing the feasibility of global and local calibrations.

GSK will also share how Raman spectroscopy was used to implement simultaneous feedback control of glucose and lactic acid in a 3L CHO bioprocess producing a monoclonal antibody (mAb).

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Wednesday, August 28th, 2019

In this webinar, the topic of particulate matter risk is approached holistically and scientifically. Results from our visible particle test (VPT) and extended visible particle inspection (eVPI) show the challenges but also point to solutions for reducing particulate matter risk in single-use systems.

The goal of the webinar is to gain feedback from end-users and to facilitate the discussion between suppliers and end-users based upon real rather than perceived risks.

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Thursday, August 15th, 2019

As gene therapies move toward commercialization, the journey to manufacture a high-quality product while achieving economies of scale and reducing facility footprint can be challenging. Developing and optimizing your process development early on is critical for your company's long-term success.

In this webinar, we will present case studies illustrating the benefits of leveraging industry experts, proven methods, and integrated bioprocess solutions to increase your speed to market while driving down manufacturing cost and risk. You will hear from Pall's Accelerator process development experts on their approach to the industry's most pressing challenges.

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Thursday, November 21st, 2019

Following up on two successful events on recent advances in the stem cell field, Eppendorf is hosting the Stem Cell Community Day 2019 on Thursday, November 21st in Lisbon, Portugal.  We invite all researchers to discuss challenges, opportunities, and achievements in stem cell bioprocessing with a special focus on controlled cultivation in stirred-tank bioreactors.

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Wednesday, August 7th, 2019

This webinar will cover the principle of dielectric spectroscopy to measure cell density in bioprocesses. It will also highlight how the technology has been used in the bioprocess industry over the past three decades. As importantly, it will talk about its recent use to measure cell density non-disruptively in 3D tissues in real time. Owing to the challenges of measuring cell density on this platform, dielectric spectroscopy offers a unique advantage of doing so in real time, reliably without disrupting the tissue. Thus, it holds promise in potentially providing a crucial quality parameter when working with such platforms and processes.

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Friday, August 9th, 2019

Real time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address Biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of product.

The BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017. As part of implementation of roadmap strategy, BPOG's ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA's and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS documents will promote effective development of desired Short, Mid and Long-term technologies by the innovators and supply partners

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Tuesday, July 30th, 2019

This webinar will review the history of biotherapeutics development to look for lessons we can learn that may accelerate advances in autologous cell therapy manufacturing. It will also highlight the differences between traditional biotherapeutics manufacture and autologous cell manufacture to identify areas which may require us to look to other industries for inspiration. Finally, it will present an integrated vision for an autologous cell therapy manufacturing facility of the future which incorporates current initiatives, lessons from the past, and ideas from other industries to improve the robustness, cost, and time of autologous cell therapy manufacture.

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Thursday, November 21st, 2019

Lisbon, Portugal 

Following up on two successful events on recent advances in the stem cell field, Eppendorf is hosting the Stem Cell Community Day 2019 on Thursday, November 21st in Lisbon, Portugal.  We invite all researchers to attend this event to discuss challenges, opportunities, and achievements in stem cell bioprocessing with a special focus on controlled cultivation in stirred-tank bioreactors.

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Tuesday, July 30th, 2019 

Engineered autologous T cell products have proven to be an extremely promising new therapeutic modality, but they are currently time-consuming and costly to manufacture. This presentation will review the history of biotherapeutics development to look for lessons we can learn that may accelerate advances in autologous cell therapy manufacturing. It will also highlight the differences between traditional biotherapeutics manufacture and autologous cell manufacture to identify areas which may require us to look to other industries for inspiration. Finally, it will present an integrated vision for an autologous cell therapy manufacturing facility of the future which incorporates current initiatives, lessons from the past, and ideas from other industries to improve the robustness, cost, and time of autologous cell therapy manufacture.

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July 18th, 2019 
 
Fujifilm and Johnson Matthey, Billingham

We invite you to attend the upcoming meeting of the UK JMP Users Group. This gathering will give you the opportunity to engage in collaborative learning with fellow JMP users and presenters. Your involvement will contribute to the collective analytics knowledge of all members through cross-industry networking, support and interactive learning.

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Biofactory Competence Center, Switzerland

September 17th - 20th, 2019

This 4-day training course will provide knowledge in advanced continuous chromatography in biopharma processes, with hands-on practical and theory in the field. The course takes the basic principles of chromatography theory and practice and builds on them to expend the range of applications in continuous mode in order to improve process productivity, resin and buffer savings.

Who should attend?

This course is aimed at industrial and academic downstream specialists, scientists and engineers in the field of bio-manufacturing who are interested in getting to know or broaden their understanding of continuous chromatography.

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Tuesday, July 30th, 2019

Engineered autologous T cell products have proven to be an extremely promising new therapeutic modality, but they are currently time-consuming and costly to manufacture. This presentation will review the history of biotherapeutics development to look for lessons we can learn that may accelerate advances in autologous cell therapy manufacturing. It will also highlight the differences between traditional biotherapeutics manufacture and autologous cell manufacture to identify areas which may require us to look to other industries for inspiration. Finally, it will present an integrated vision for an autologous cell therapy manufacturing facility of the future which incorporates current initiatives, lessons from the past, and ideas from other industries to improve the robustness, cost, and time of autologous cell therapy manufacture.

Presented by Geoffry Hodge, Chief Technical Officer at Unum Therapeutic 

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Monday, July 1st, 2019

During the lengthy process of pharmaceutical development, an Active Pharmaceutical Ingredient (API) or its intermediates can go through many physical and chemical changes. These changes are needed to produce the API with the correct chemical structure and physical property. Monitoring the progress of these transformations is important for the process understanding as well as serving as a tool for in-process control (IPC) to ensure the completeness of the transformation. IR and Raman Spectroscopies are sensitive to both chemical and physical changes of a compound and have evolved into useful tools in our lab for process monitoring.

Presented by John Wasylyk, Sr Principal Scientist at BMS and Karen Esmonde-White, Senior Marcom Specialist at Kaiser Optical Systems Inc 

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Tuesday, June 25th, 2019

Stricter regulations have required life sciences companies to place even more emphasis on their regulatory compliance. Some of them use Electronic Batch Records (EBR) to report on their batch operations and to implement operational excellence programs to improve KPI's like OEE. They also monitor their processes in real-time in order to optimize the entire supply chain.

In this webinar, learn how life sciences companies use the PI System to improve regulatory compliance, increase throughput, reduce time-to-market, and improve knowledge management.

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Monday, July 22nd - Wednesday, July 24th, 2019
The Four Seasons Hotel Washington, DC

The Summit's role is to inform, provoke and air topical business issues relevant to both the vendor and end user bases - which is at the heart of BPSA's mission. BPSA remains the safe harbor venue where suppliers and end-users can meet to discuss business challenges, technical issues and implementation strategies for SUTs.

BPSA's 2019 Summit will continue to provide its attendees with topics geared toward the global business of single-use, as well as ample opportunity to network with your customers and peers from around the world.

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Thursday, June 20th, 2019

Biopharmaceutical plants will look different in the future. Agility and flexibility for rapidly changing product portfolios, single-use technologies, continuous manufacturing, small batch manufacturing, personalised medicine manufacturing will not only change the face of a plant but will also require other logistics models.

Chris Chen, CEO of WuXi Biologics will explain their approach to biological facilities of the future.

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Tuesday, June 25th, 2019

The European Directorate for the Quality of Medicines announced that the highly purified water (HPW) monograph would be suppressed in 2019, and pharmaceutical companies were left to wonder about the implications this has for their operations. How will HPW become water for injection (WFI)?

On Tuesday, June 25th, subject matter experts Fritz Röder from Merck KGaA and Jochen Schmidt-Nawrot from CRB will host a webinar to answer the questions many production, qualification and quality assurance specialists are asking.

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Tuesday, June 18th, 2019

What is the Factory of the Future? It is a vision of a holistic company-wide transformation, which balances and combines: productivity, quality, and robustness based on a data-centric perspective. In this webinar we will address the question of whether it is possible to build the Pharma Factory of the Future today, increase quality and productivity, and decrease the cost at the same time.

Key Learning Objectives

  • What is the Factory of the Future concept
  • Automation strategy to build the Pharma Factory of the Future
  • Lessons learned and most common pitfalls
  • Use case. Company-wide efficiency metrics platform

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Wednesday, June 12th, 2019

With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on single-use container closure integrity (SU CCI), raising the need to develop good science behind liquid leakage and microbial ingress and appropriate physical integrity testing technologies.

This webinar will address the following;

  • Review the emerging industry associations' initiatives and introduce an integrated quality by design, material science and process control approach
  • Describe how applying good science help determine the maximum allowable leakage limit (MALL) under which no product leakage and no bacteria ingress occurs
  • Share the development of highly sensitive deterministic integrity testing technologies such as gas tracer detection and pressure decay

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Wednesday, July 17th, 2019

Chelmsford, Massachusetts

At this complimentary event you will learn virus filtration theory and technique from the experts  at our new training center in Chelmsford, Massachusetts.

Course Includes:

  • Classroom Theory
  • Instruction and Discussion
  • Hands-On Laboratory Experience
  • Training Certificate Provided

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Wednesday, June 12th, 2019

With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on single-use container closure integrity (SU CCI), raising the need to develop good science behind liquid leakage and microbial ingress and appropriate physical integrity testing technologies.

This webinar will address the following;

  • Review the emerging industry associations' initiatives and introduce an integrated quality by design, material science and process control approach
  • Describe how applying good science help determine the maximum allowable leakage limit (MALL) under which no product leakage and no bacteria ingress occurs
  • Share the development of highly sensitive deterministic integrity testing technologies such as gas tracer detection and pressure decay

Learn More

Tuesday, June 18th, 2019

What is the Factory of the Future? It is a vision of a holistic company-wide transformation, which balances and combines: productivity, quality, and robustness based on a data-centric perspective.

Is it possible to build the Pharma Factory of the Future today, increase quality and productivity, and decrease the cost at the same time? Yes, and your automation strategy should become a user-driven program that combines:

* The equipment standardization program
* The right global, company-wide infrastructure
* The creation of a Global Data Model

The Factory of the Future can only be defined in terms of performance and KPIs. It needs a multi-disciplinary approach, where technology has to be a tool supporting and giving answers to business needs.

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