Event Alert

Wednesday, March 27th, 2019

The new hygienic thermometer, iTHERM TrustSens, is designed for users in the biopharma industry requiring absolute compliance to cGMP standards. Our product eliminates the risk of undetected deviations during production by conducting a fully automated inline calibration before each bioprocess run without any effort. This results in maximum product safety and bioprocess availability.

In this webinar you will learn how the iTHERM TrustSens meets the high standards set forth for cGMP compliant calibration.

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Thursday, March 28th, 2019

A major challenge of running microscale bioreactor systems is the ability to generate a full profile of offline cell culture and metabolite data such as cell counts, pH, pCO2, glucose, lactate and ammonia covering the entire duration of the run due to limited culture volume available for sampling. The combination of the FLEX2 and the ambr® 15 solves this problem.

This webinar will be presented by Rahul Pradhan, Senior Scientist in Cell Culture Development at Kymab who will discuss a case study on a manufacturing cell line screening campaign for a Kymab monoclonal antibody fusion protein.

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Tuesday, March 26th, 2019
Wednesday, March 27th, 2019

InfoBatch is a manufacturing reporting suite that simplifies compliance documentation, production reporting and process analytics. The world's leading manufacturing facilities have improved productivity and reduced costs with InfoBatch.

Join us for a live webinar as we demonstrate the unique features that set InfoBatch apart. Questions and open discussion are welcome!

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Wednesday, March 27th, 2019

Eppendorf invites you to be our guest at a complimentary bioprocess workshop where attendees will benefit as we present and discuss information on Scalability - Process Scale-up Made Easy Using Standard Methods and Techniques. We will also discuss two of our recent Application Notes on rAAV Production in Suspension CAP GT® Cells and Redox Potential Monitoring for Improved Anaerobic Fermentation.

Our 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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Wednesday, March 20th, 2019

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.

In this webinar, attendees 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. We will also present case studies on how the technology has been used to improve manufacturing performance.

8:30 AM EST or 9:30 AM PST

Thursday, March 14th, 2019

In this webinar Charlotte Masy, Project Manager at GSK, will share how defect mode analysis has allowed GSK to build a risk assessment and a strategy on integrity. This strategy is very important for critical applications when single use is used after last sterile filtration or in process no sterile filtration is possible. Several case studies supporting this approach will be shared showing the importance of addressing integrity in the context of use, taking all technical aspects into consideration and present data analyzing the effect of such a strategy on lowering defect occurrence.

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Tuesday, March 5th, 2019

In this webinar, the benefits of Pall's chromatography process, which features KANEKA KanCapA, Mustang® Q and CMM HyperCel™ sorbents will be presented with a focus on the specificity of CMM HyperCel sorbent versus traditional cation exchangers or other mixed-mode resins. This three-step process can be operated without any need for diafiltration or dilution between the chromatography steps. We will demonstrate the robust performance of the CMM HyperCel sorbent within a streamlined batch process, which consistently provided purified mAb with high yield and purity.

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Thursday, February 28th, 2019

Please join us for a 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. Learn More

Wednesday, February 27th, 2019

This webinar will discuss the rising demand for biologics combined with the need for deeper process understanding, reduced development times and ever-increasing pressure on costs compels the Biotech industry to transform its production models. Modernization of manufacturing tools includes the switch towards intensified downstream processes assuring a maximum of control by applying process and analytical tools.

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Thursday, February 28th, 2019

In this Webinar we will cover a highly innovative and flexible family of 8 cGMP chromatography systems that are designed to enable scientists in Process Development (PD), MSAT ( Manufacturing Science and Technology), or Manufacturing Engineering to purify and scale- up their chromatography separations from Bench ( 0-100mL/min) to Production Scales. (up to 40 Lpm).

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Wednesday, February 20th, 2019
Emeryville, CA

Thursday, February 28th, 2019
Cambridge, MA

Please join us for one of our one-day seminars 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.

Seminar Partners:

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Tuesday, February 19th, 2019

In this webinar, several applications of Raman technology in biopharmaceutical processes will be presented. The applications will range from different upstream processes to first downstream applications, to monitoring classical process parameters as well as quality-related attributes. Moreover, a new flow cell will be introduced, which enables the use of the technology in chromatography and small volume samples. Insights of modeling procedures including a concept to fuse mechanistic knowledge with online sensor information will be shared. Finally, the importance of Raman spectroscopy for continuous and integrated upstream and downstream bioprocesses will be discussed.

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3-Day Training Course, Fribourg, Switzerland

This 3-day training course will provide an introduction to continuous down-stream processing with hands-on practical and theory in process development and bio-manufacturing. It will give an introduction to different available technologies for continuous cell-separation, ultrafiltration, diafiltration and chromatography. The principles on process-integration, quality-by-design, scale-up and economic considerations for continuous processing will be discussed.

Course 1: March 26th - 28th, 2019
Course 2: May 21st - 23rd, 2019
Course 3: October 15th - 17th, 2019

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Tuesday, February 19th, 2019

10:00 AM EDT

In this webinar, several applications of Raman technology in biopharmaceutical processes will be presented. The applications will range from different upstream processes to first downstream applications, to monitoring classical process parameters as well as quality-related attributes. Moreover, a new flow cell will be introduced, which enables the use of the technology in chromatography and small volume samples. Insights of modeling procedures including a concept to fuse mechanistic knowledge with online sensor information will be shared. Finally, the importance of Raman spectroscopy for continuous and integrated upstream and downstream bioprocesses will be discussed.

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Tuesday, February 26th, 2019
Raleigh-Durham, NC

11:00 a.m. - 2:00 p.m.

Mettler Toledo and FLW Southeast are offering a No-Cost Seminar/Lunch & Learn on Pharmacopeia Regulations, Pharmaceutical Waters, Calibration Requirements & Procedure for Pharmaceutical Compliance.

Registration is required, as seating availability is limited.

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Tuesday, February 12th, 2019

National Biologics Manufacturing Centre,
CPI, Darlington

Upstream - Purification - Process Analytical Technolgies and Data Analytics - New Automation Technology

These 4, one hour long, workshops will involve equipment overviews (some in situ at CPI), along with case studies from technical experts conveying how these solutions could optimize and intensify your process.

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Webinar - Wednesday, January 30th, 2019

This webinar will address the rising demand for biologics combined with the need for deeper process understanding, reduced development times and an ever-increasing pressure on costs that compels the Biotech industry to transform its production models. Modernization of manufacturing tools includes the switch towards intensified downstream processes assuring a maximum of control by applying process and analytical tools.

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Webinar - Tuesday, January 22nd, 2019

Presented by Yasser Nashed-Samuel, Principal Scientist at Amgen

In this webinar, a case study on extractables from single-use bioreactors/bags and their impact on mammalian cell culture performance will be presented. Plastic single-use bioreactors are of interest to biopharmaceutical drug manufacturers due to their significant environmental and cost benefits and flexibility over stainless-steel bioreactors. Effect of plastics on the biomanufacturing process is not yet completely understood.

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Webinar - Thursday, January 17th, 2019

Presented by Lance Marquardt, Associate Director Upstream Processing, Bristol-Myers Squibb

This webinar will provide an overview of the current use of single-use manufacturing within the Bristol-Myers Squibb manufacturing networks and planned future state. The challenges in implementing single-use manufacturing for commercial production will be discussed. Comparisons will be made to the implementation of past improvements and the plans for future improvements, such as continuous processing.

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Webinar - Monday, January 14th, 2019

Presented by Ben Jevaretnam, E&L Analytics Lead, Sanofi at Swiftwater

The pharmaceutical 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 user faces during the qualification process.

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Webinar - Wednesday, January 9th, 2019

Presented by Don Singer Manager, Steriles Microbiology, for GlaxoSmithKline R&D

Risk management is not new to Quality Control Microbiology. In fact, microbiological control in the pharmaceutical industry has been following risk management concepts for over half a century. The Microbiologist's role in this transformation of industry to a Quality by Design (QbD) thinking paradigm has become very crucial. The use of quality tools has increased, to help develop a better understanding of how and where to implement microbiological control of processes. Some quality tools can also be used to present information to others in an organized, pragmatic manner.

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Webinar - Tuesday, January 15th, 2019

The Best of BIOT awards are BIOT's annual recognition of excellent presentations given at the spring ACS National Meeting. The winners are selected based on audience and session chair voting. Each recipient is invited to give a webinar reprising the original presentation.

In an effort to promote scientific discourse and connectivity throughout the BIOT community, this year, the webinars are provided free of charge.

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Webinar - Tuesday, December 11th 2018

One of the main challenges when considering single-use technologies in sterile vaccines processing is to ensure the highest level of assurance of integrity and sterility. This requires a strong collaboration and shared responsibility between the supplier and the end-user.

This webinar will develop the Quality by Design (QbD) aspects contributing to the assurance of integrity of Single-Use Systems (SUS) in the context of sterile vaccines processes. This will be presented from both an enduser's perspective (GSK) and a supplier's perspective (Pall).

Participants will learn:
The importance of interactions between suppliers and endusers for SUS implementation
How to manage sterility assurance concerns
How to assess and define the most appropriate mitigation strategy
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Live Webinar - Thursday, December 6th 2018

Mycoplasma contamination can have a devastating impact on biopharmaceutical productions, so quick and reliable screening of materials is critical for minimizing the risk of contamination. The traditional FDA Points to Consider (PTC) has long been considered the preferred mycoplasma test for cell culture media and supplements, but it is a lengthy method requiring trained microbiologists and cultivation of live mycoplasma. PCR has been gaining acceptance as a method for quickly and accurately screening raw materials. However, most commercially available PCR methods have been optimized for screening cell lines or cell culture media and not complex materials like peptones, which are widely used as cell culture supplements in biological production.

Please join us to learn more about the MycoTOOL qPCR assay and how this technology has been optimized for the testing of peptones.

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Live Webinar - Thursday, December 6th 2018

Viral vectors have become one of the most rapidly evolving and promising fields in vaccinology and regenerative medicine. The development of the Downstream Process is challenging because each vector has its own properties. There is not one-fit-all solution. How then should process development scientists approach the development of a viral vector purification process, knowing that each process is unique?

This webinar will give you an overview of the Sartorius approach to accelerate the development of Downstream Processing, combining our well proven technologies - such as membrane chromatography and tangential flow filtration - with state-of-the art automated systems and Design of Experiment Software.

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Live Webinar - Wednesday, December 5th 2018

Single use processing has become increasingly more prevalent in bio-manufacturing. While its use is prolific in cell culture, filtration, mixing and buffer management at all scales in applications ranging from plasma processing, MAb manufacturing to Gene Therapy, its use in chromatography has been limited primarily due to the lack of "right size/ scale" equipment for these different applications.

In this LIVE Webinar, Vinit Saxena, CEO of Sepragen, will share specific examples with case studies of how biophama companies are overcoming cGMP challenges in their bioprocessing facilities.

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Live Webinar - Tuesday, December 11th 2018

The Best of BIOT awards are BIOT's annual recognition of excellent presentations given at the spring ACS National Meeting. The winners are selected based on audience and session chair voting. Each recipient is invited to give a webinar reprising the original presentation.

In an effort to promote scientific discourse and connectivity throughout the BIOT community, this year, the webinars will be provided free of charge.

Learn More

Live Webinar - Thursday, November 15th 2018

High Productivity Harvest (HPH) is a novel application developed by Repligen that enables you to harvest a fed batch bioreactor in a fully sterile manner while eliminating both centrifugation and depth filtration. A 0.2µm filtered, closed system and single step process using the XCell™ ATF System, HPH can significantly increase yields above industry standards and generate a sterile clarified batch harvest ready for batch or continuous chromatography.

This webinar will demonstrate how HPH works, present initial results of up to a 2-fold increase in protein production, and how you can apply HPH specific to your product need or facility design.

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Live Webinar - Tuesday, November 13th 2018

The Best of BIOT awards are BIOT's annual recognition of excellent presentations given at the spring ACS National Meeting. The winners are selected based on audience and session chair voting. Each recipient is invited to give a webinar reprising the original presentation.

In an effort to promote scientific discourse and connectivity throughout the BIOT community, this year, the webinars are being provided free of charge.

Learn More

Live Webinar - Wednesday, November 7th 2018

With several recent FDA approvals and a strong drug pipeline, the gene therapy market is coming of age and providing new hope for patients. As demand for these new therapies increases, a robust and scalable manufacturing process is critical. In this webinar, we will present an end user case study which illustrates the challenges and solutions to scale both the upstream and downstream process steps required to manufacture adenoviruses.

Participants will learn how to:
Accelerate time to market for adenovirus manufacturing
Design the process for scalability
Reduce downstream processing time from 3 - 4 days to 1 day

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Live Webinar - Tuesday, November 6th 2018

30 years ago Sepragen developed the concept of Radial Flow Chromatography, and it is still widely used in the Bioprocessing community. Radial Flow Columns provide an elegant, simple and proven way to scale up sample volumes and flow rates in small diameter (Small footprint) columns. The Radial Flow Columns, termed Superflo®, can be used with any Ion Exchange, Affinity & Hydrophobic Interaction Chromatographic resin.

In this webinar Vinit Saxena, CEO of Sepragen, will be showing specific examples with case studies of how companies are using Radial Flow Chromatography to optimize their Chromatography.

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Live Webinar - Wednesday, November 7th 2018

Pharmaceutical manufacturing has traditionally been managed manually, with experienced people making most strategic and tactical decisions. Algorithms have focused mainly around very detailed recipe execution and very high scale enterprise-wide resource planning. However with machine learning, artificial intelligence and other optimization technologies being rapidly implemented in other industries, there has been significant interest in how they might help pharma.

In this webinar we'll examine how optimization algorithms can drive consistently better decisions in pharmaceutical manufacturing. SmartFactory Rx has delivered Pharma CPV solutions that drive higher yield, better quality outcomes, and a greater knowledge about the process.

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Live Webinar - Tuesday, November 13th 2018

The Best of BIOT awards are BIOT's annual recognition of excellent presentations given at the spring ACS National Meeting. The winners are selected based on audience and session chair voting. Each recipient is invited to give a webinar reprising the original presentation.

In an effort to promote scientific discourse and connectivity throughout the BIOT community, this year, the webinars will be provided free of charge.

Learn More

Webinar - Tuesday, October 16th, 2018

The Best of BIOT awards are BIOT's annual recognition of excellent presentations given at the spring ACS National Meeting. The winners are selected based on audience and session chair voting. Each recipient is invited to give a webinar reprising the original presentation.

In an effort to promote scientific discourse and connectivity throughout the BIOT community, this year, the webinars are provided free of charge.

Learn More

Webinar - Tuesday, October 16th, 2018

The Best of BIOT awards are BIOT's annual recognition of excellent presentations given at the spring ACS National Meeting. The winners are selected based on audience and session chair voting. Each recipient is invited to give a webinar reprising the original presentation.

In an effort to promote scientific discourse and connectivity throughout the BIOT community, this year, the webinars are provided free of charge.

Learn More

On-Demand Webinar

Single-use technologies require a shift of responsibility from biomanufacturers to suppliers to enable production of safe and reliable drugs. One of the pre-requisites for efficient supply is to have standardized processes to design and manufacture single-use systems. We have developed a unique design, quality and business tool to drive quality and responsiveness, and to support standardization of single-use technologies.

Dr Hélène Pora will take you through the functionalities of this system and demonstrate what benefits it brings to end users when implementing single-use technologies in a regulated environment.

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On-Demand Webinar

In this webinar with Seeq and Alkemy Innovation, we will focus on specific case study examples utilizing an agile framework to analyze non-continuous batch-focused data. Seeq simplifies the extraction of insights and value from data historians and varied disparate data sources specific to batch processes at any scale.

Our expert speakers will discuss how you can leverage data analytics strategies to achieve:
Development of data-driven models relating product quality to key process variables
Elimination of time-consuming cutting and pasting of data
Reduced equipment cycle times with a cost-saving predictive maintenance approach
Automation of repeated analysis tasks with an eye towards streamlined reporting
Establishment of a truly collaborative problem-solving environment
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Wednesday, September 26th, 2018

For many facilities, continued process verification (CPV) is yet another quality requirement to adhere to. But what if CPV was a means to drive tangible improvements to manufacturing operations?

In this webinar, we'll show how CPV done right drives a deeper understanding of the relationship between parameters and product quality. SmartFactory Rx has delivered Pharma CPV solutions that drive higher yield, better quality outcomes, and a greater knowledge about the process.

Join us to see how Applied's solutions can move your CPV program beyond quality requirement to right first time.

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3 Day Training Course

September 25th - 27th, 2018

The Biofactory Competence Center has partnered with Pall Biotech to launch a new training course focused on industry advances. Attendees will learn everything from the basics of biotechnology from customized process design through to development and optimization in biomanufacturing.

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Thursday, September 20th, 2018

Live Webinar

In recent years a clear trend towards continuous biopharmaceutical processing has gathered momentum, driven by the promise of higher productivity, reduced cost of goods and more consistent product quality. Bench top bioreactors can be used to develop this new wave of intensified/continuous cell culture processes, however this approach is manually intensive, low throughput and very cost-intensive to operate.

This webinar will be presented by Dr Barney Zoro, ambr 250 Product Manager at Sartorius Stedim Biotech, and will discuss a new automated mini bioreactor system which has been specifically developed for perfusion cell culture.

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August 29th, 2018

The pharmaceutical industry is increasing the rate of adoption of advanced manufacturing techniques such as continuous manufacturing. Manufacturing approaches such continuous rely on in-process measurements to a much larger extent than previous ones. NIR spectroscopy has historically been the predominant spectroscopic measurement for these in-process requirements. More recent advances in Raman technology along with other benefits such as increased chemical specificity and reduced interference from physical changes make it an appealing option which is seeing an increase in adoption in-process. Here we will present work demonstrating the utilization of the Kaiser Raman system within a continuous pharmaceutical tableting line along with comparisons to NIR.

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September 26th - 28th, 2018

Barcelona, Spain

BPSA will host its second European Single-Use Summit in Barcelona, Spain on September 26-28, 2018, at the Crowne Plaza Barcelona - Fira Center. The European Summit program will address the SUT industry's business challenges, technical issues and implementation strategies specific to its European audience. The Summit will also allow ample time to network with colleagues and customers.

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Using Multivariate Data Analysis to Pursue Golden Batch Technology in Animal Health

Live Webinar

Wednesday, September 5th, 2018

The story of pharmaceutical production is often a quest for the golden batch: a repeatable process that consistently produces the optimizes yield and quality. Recently an animal health subsidiary of Boehringer Ingelheim-a top international pharmaceutical company began collaborating with OSIsoft and Sartorius Stedim Data Analytics on a project that uses multivariate data analysis techniques (MVDA) to create golden batch trajectories based on historic data. These golden batch trajectories could then be used for real-time monitoring and prescriptive process control for higher potency batches.

Watch this webinar to see how data science and OSIsoft's PI System have enabled advanced batch evolution modeling so that Boehringer can now see things as they are happening or even before they happen with each batch.

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Keeping the Data Lake from Becoming a Data Swamp

The perfect world for industrial data processing does not exist yet. Pushing all production and operational data in a raw format to a central big data store will result in a data swamp instead of a data lake. Only specialized data scientists will be able to make sense out of the data. In an industrial environment, preprocessing of all real-time data is essential. Bringing context to the data is a must to assure that business users can leverage the data to optimize operations.

In this webinar John de Koning will discuss how leveraging the right technology to combine a data lake with a real-time infrastructure is crucial to optimize your business.

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At the heart of key challenges facing biologics laboratories today lies the volume and complexity of data created throughout the scientific process. Whether this is biologics experimental data recorded as part of a cell line development, upstream, downstream, or analytical processes, or result and raw data generated through instrumentation, extracting, analyzing and reporting on this data in different formats, from disparate sources, can cost businesses results, time, and money.

Join us for this webinar to learn about:
Key challenges biologics researchers face today with outdated technologies, manual processes, siloed data, and increasing pressure to innovate your R&D
The effects of poor data management on your lab - and the different facets to address to be able to conduct data mining, share information across teams, and harmonize contextualized data capture
How a winning workflow execution can optimize your processes to increase efficiencies, improve product quality, and enable effective collaborations with your teams

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Analyzing Your Data with the PI System in the World of Machine Learning and Data Science

The industry is all a buzz with the idea of 'machine learning' and 'analytics' - these are the latest shiny objects everyone is talking about and trying to bring value to their organization with. But, there is also a lot of confusion on what these terms mean, and more importantly, how and where to implement them for success.

Topics addressed:
How best to handle different types of analytics
Where does machine learning and advanced analytics fit
What are best practices for using analytics with the PI System

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Wednesday, July 18th, 2018

In this webinar our expert, Dr. Mark Snyder, will discuss the application use of CHT XT at process-scale and provide guidelines on where to start when selecting a hydroxyapatite media for your purification. Our newest mixed-mode media, Ceramic Hydroxyapatite XT, is a calcium affinity cation exchange chromatography media. It is used for the purification of numerous types of biomolecules and provides single-step clearance of impurities and aggregates for monoclonal antibody purification. CHT XT is an easy-to-use mixed-mode chromatography media. Unlike other chromatography media it is both the ligand and the support matrix.

Topics to be discussed:
Introduction of hydroxyapatite mixed-mode media
Monoclonal antibody purification
Virus purification
Guidelines for selecting hydroxyapatite media

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Wednesday, July 18th, 2018

In this webinar, we'll show how SmartFactory Rx Knowledge Management frames and stores learnings to break the repeating cycles of deviations. Applied's solution integrates with your existing data systems to guide operators' reactions to out-of-control situations.

Agenda:
How Applied's Industry 4.0 platform is being used to store structured knowledge on how to react to adverse events, using technology and lessons learned from semi-conductor manufacturing
How our software product can collect and structure data from any system - LIMS, MES, DCS, PI - to drive insight in real-time
How the system can be used in real-time to drive continuous learning and reduce issue resolution times

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Wednesday, July 11th, 2018

Three-dimensional (3D) cell aggregates are of great interest for many applications, including disease modeling, drug toxicity assessment, and manufacture of stem cell-based products. Stirred-tank bioreactors are promising culture systems for 3D cell aggregates, as they allow efficient establishment and maintenance of cell aggregates, process monitoring and control, and process scale-up to larger volumes. Furthermore, they can be operated in perfusion mode, which allows 3D cell aggregates to be sustained longer than in traditional batch cultures. This complimentary webinar will review a research example for process development cultivated in stirred tank mini bioreactors as 3D cell aggregates.

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SCIX 2018

October 21st - 26th, 2018

Atlanta, Georgia

Leading researchers will convene to present their cutting edge developments in analytical sciences, instrumentation, and unique applications. The SciX meeting hosts a world-class exhibition, presentations from leading scientists, educational courses, and many networking opportunities.

Poster abstract deadline is July 31st. Go to online paper submission. We look forward to your participation at SciX 2018 in Atlanta, GA.

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Presented by Nobel Vale, Research Scientist II, Bristol-Myers Squibb

July 11th, 2018

Raman has been seen as a spectroscopic tool used in bioprocessing to monitor and control cell metabolism to optimize quality and yield of titer. This is due to Raman's insensitivity to water and ability to analyze samples without manipulation. However there are certain challenges for Raman when analyzing a complex and dynamic sample such as a cell culture. This webinar will discuss in detail the different challenges associated with analyzing in-line Raman data and how to mitigate changes in samples that include changes in fluorescence background, presence of cells and debris in samples, as well as spectral interference.

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Biomanufacturing Summit 2018 will mark the seventh annual event of the Biomanufacturing Science and Technology Consortium. Expected summit participants are scientists and engineers from bio-pharmaceutical manufacturers, technology/system providers, raw material suppliers and agencies in the areas of development, manufacturing, and engineering. We hope professionals and leaders of biopharmaceutical industry will be able to get together and talk about future biomanufacturing challenges and breakthrough technology. It will also be a great chance to network with professionals from major bio-pharmaceutical manufacturers and various technology providers such as Biogen IDEC, Genzyme, Pfizer, Momenta, MilliporeSigma, BMS, GE, SAFC and many more.

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Tuesday, June 26th, 2018

This webinar will give you an overview of Sartorius' platform approach to process development. This approach allows companies to reduce the time required to bring their products to the clinic and to market while providing them with consistent process performance. The presenter will describe the toolbox of technologies and services proven to be efficient in the development, production and analysis of viral vector processes. The performance of a single-use viral vector platform will be illustrated by a case study based on adenoviruses.

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Thursday, June 28th, 2018

Worcester, MA

Join us for a half day workshop in Worcester MA to review key bioreactor design characteristics and learn the best practices and technical advances implemented in Applikon's current bioreactors. Scaling parameters, sensor operation and integration, and advanced control strategies will be addressed. Hands on sessions will bring the concepts to life with our experts guiding you through operation of the hardware while optimizing the use of today's highly integrated software solutions.

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June 27th - 28th, 2018

The Biomanufacturing Science and Technology Consortium at UML is hosting its 7th Annual Biomanufacturing Summit from Wednesday, June 27th to Thursday, June 28th, 2018. As in previous years, summit participants are expected to be scientists and engineers alike from bio-pharma companies, technology/system providers, raw material suppliers and others in the areas of development, manufacturing, and engineering. We hope leading biopharma professionals will come together discuss future biomanufacturing challenges and breakthrough technologies.

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Tuesday, June 19th, 2018

Durham, North Carolina

Thursday, June 21st, 2018

Cambridge, Massachusetts

Join us for a series of industry case studies designed to enable you to learn from key thought leaders and adopters of transformative technologies such as Biogen, Fujifilm, KBI Biopharma and more. Please note that while there is no charge for attendance, registration is required. Seats are limited to end-users of bioprocessing tools and technologies.

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Thursday, June 28th, 2018

Biomanufacturing Education and Training Center
WPI, Gateway Park
Worcester, MA. USA

Join us for a free half day workshop in Worcester MA (USA) to review key bioreactor design characteristics and learn the best practices and technical advances implemented in Applikon's current bioreactors. Scaling parameters, sensor operation and integration, and advanced control strategies will be addressed. Hands on sessions will bring the concepts to life with our experts guiding you through operation of the hardware while optimizing the use of today's highly integrated software solutions.

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June 11th-12th, 2018

University of Maryland Bioprocess Scale-up Facility
College Park, Maryland

The University of Maryland, College Park, in cooperation with the University of Maryland, Baltimore County, and the Institute for Bioscience and Biotechnology Research, is offering a two-day fermentation microbiology workshop on state-of-the-art fermentation processes and practices. The workshop provides hands-on experience and instruction with various fermentation systems and acquaints attendees with the techniques, methodologies, principles and applications of aerobic bacterial and fungal fermentation. The workshop provides an opportunity for participants not only to learn the principles of bacterial and fungal fermentation scale-up at the bench, but recent advances and up-to-date applications of this methodology.

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June 11th-12th, 2018

University of Maryland Bioprocess Scale-up Facility
College Park, Maryland

The University of Maryland, College Park, together with industry experts, is pleased to offer a two-day workshop on cell culture technology. The session features hands-on instruction with various cell culture expression systems and introduces attendees to the techniques, methodologies, principles, and applications of anchorage-dependent and suspension-adapted cell lines. The workshop provides an opportunity for participants not only to learn the principles of cell culture scale-up at the bench but also covers recent advances and up-to-date applications of this methodology including single-use systems.

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Thursday, June 28th, 2018

Biomanufacturing Education and Training Center
WPI, Gateway Park
Worcester, MA. USA

Join us for a free half-day workshop in Worcester MA (USA) to review key bioreactor design characteristics and learn the best practices and technical advances implemented in Applikon's current bioreactors. Scaling parameters, sensor operation and integration, and advanced control strategies will be addressed. Hands-on sessions will bring the concepts to life with our experts guiding you through operation of the hardware while optimizing the use of today's highly integrated software solutions.

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Increase Bioprocess Yield by Capturing Real-Time Data

Tuesday, June 5th, 2018

On-line parameters like pH and dissolved oxygen are commonly used to optimize process yield. Further optimization is now possible with a new breed of sensors for on-line measurement of viable and total cell density.

In this 45 minute webinar you will:
Learn about the impact of continuous, in-situ cell density measurements compared traditional off-line sampling

Learn how you can create your own process optimization plan using new sensor technology
Learn about the experiences of those who have tried the technology and saw positive results

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Wednesday, June 6th, 2018

GMP requirements touch every single use assembly used, from clinical studies to commercial manufacturing and everything in between. As such, it is imperative that GMP practices be followed when producing these single-use assemblies so as to ensure there is no risk to patients in clinical trials and with future commercial products. Failing to do so will further the perception of some that there are inadequate quality controls on single-use assemblies which will lead to the use of said assemblies not being accepted by regulatory agencies and internal quality departments.

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Thursday, June 7th, 2018

Opportunities for process intensification exist throughout the entire monoclonal antibody process. With the implementation of perfusion-based operations from seed train to production bioreactors, and downstream technologies such as intensified capture chromatography, in-line virus inactivation, and flow-through polishing, a variety of scenarios for Mab production trains become apparent. In this presentation, we will identify several of these production scenarios with process modeling data to quantify the financial benefits and holistic value derived from the integration and intensification of Mab processes.

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Tuesday, June 19th, Durham, NC.

Thursday, June 21st, Cambridge, MA.

At Repligen bioprocessing seminars, thought leaders and professionals from around the world meet and review exciting new drivers of bioprocessing efficiency, learn from adopters of transformative technologies from Biogen, Fujifilm, KBI Biopharma and more, evaluate risk landscapes and collaborate to help set the standards for modern bioproduction.

Thursday, May 17th 2018

In order to adapt towards more targeted therapies for niche populations, biopharmaceutical manufacturers will need to produce multiple high potency products, with greater changeovers, and at smaller batch sizes. By significantly reducing capital outlay, disposable modular facilities allow for both product and geographical manufacturing flexibility. Production is thus enabled at a lowered associated risk wherever assets are best utilized and production costs minimized, such as in emergent markets.

Presented by

Adam Goldstein, Roche/Genentech
Jacob McNeil, Thermo Fisher Scientific

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Tuesday, June 5th - Thursday, June 7th, 2018

Goettingen, Germany

For over 10 years, the Upstream & Downstream Forum has proven to be an exciting venue for presentations, networking and discussions focusing on the latest applications and technologies.

The event continues to build the collaborative bridge between Upstream & Downstream Bioprocessing by bringing specialists from your peer group who will share their experience by presenting best practices, applications and techniques to address the bottlenecks at the interfaces of upstream and downstream.

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Tuesday, June 12th - Thursday, June 14th, 2018

Burlington, MA.

This high-level course explores the implementation of cutting-edge tangential flow filtration (TFF) techniques and technologies. This course includes a choice of technically rigorous modules which address high-level scientific concerns within tangential flow filtration design and implementation, including high-viscosity tangential flow filtration (HVTFF), single-pass tangential flow filtration design (SPTFF) and operation, and two-pump microfiltration (MFTFF).

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Tuesday, May 8th 2018

Bio-Rad Laboratories invites you to attend the Advancements in Downstream Purification Symposium at the Institute for Bioscience and Biotechnology Research. This symposium will provide an interactive discussion of new developments in purification from capture to polishing of biotherapeutics.

Join us and key industry leaders as we discuss case studies and new technologies to advance downstream processing.
Listen to case studies in process development with focus on mixed-mode chromatography, viral clearance, virus and mAb purification and aggregate removal
Learn about new chromatography functionalities
Submit a poster abstract and participate in the poster session
Collaborate with industry professionals and discuss current separation challenges

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July 3rd - 5th, 2018

The BioFactory Competence Center (BCC) in Fribourg, Switzerland has partnered with Pall Biotech to offer a continuous downstream processing training course from
July 3rd - 5th, 2018. Attendees will learn about the different technologies available for continuous processing steps
including cell separation, filtration and chromatography. The three day course is focused on practical hands-on work in the laboratory with small class sizes.

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MCSGP is a counter-current chromatography process that simultaneously achieves high yield and purity in difficult peptide purifications. The increased yield of MCSGP ... allows downscaling of the upstream chemical synthesis steps improves productivity of the downstream process leading to smaller columns required reduces solvent consumption eliminates the need for re-chromatography avoids generation of side-fractions to be stored and analyzed (reduction of analytical burden) Learn More

Wednesday, May 2nd 2018

In this webinar, we'll show how pharma manufacturers are implementing SmartFactory Rx to deliver predictive maintenance, without the need for additional sensors. Applied's solution integrates with your data systems to effectively predict patterns 'outside the norm' and automate the response - including opening a maintenance ticket. It builds on your team's engineering knowledge and the latest in machine learning to build a system that can automatically learn and respond in real-time.

Agenda:

  • How Applied's Industry 4.0 platform is being used to accurately predict potential break-downs days in advance, using technology and lessons learned from semi-conductor manufacturing
  • How our software algorithms reduce nuisance alarms and focus maintenance effort ahead of any problems
  • How predictive maintenance can be used to drive continuous improvement and reduce down-times
  • How Pharma can transform maintenance from a "regulation requirement" to a means of ensuring process efficiency

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Thursday, April 26, 2018

In this 45-minute webinar, experts from Pall Biotech will discuss the approach and strategy to ensure the highest level of assurance of integrity of SUS in drug substances and drug products processes. They will take into account the life cycle of the SUS; from its manufacturing to end user's deployment and use.

Presented by:

Hélène Pora (Moderator)

Nathalie Pathier (Speaker)

You will learn about:

  • The industry trends and recommended approach for the assurance of integrity of single-use systems
  • Available solutions for the highest level of assurance of integrity of SUS
  • A new integrity test for Allegro 2D biocontainer assemblies


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Join one of our seminars and learn about the latest developments in bioprocess automation for laboratory scale development. The seminar will focus on DeltaV Discovery and V-Control, an automation system built on this system, together with proprietary control systems and Lucullus Process Information Management Systems (PIMS), a single functions and instrumentation from experimental design to planning, execution, data analysis and reporting. Demonstrations of each technology will be provided.

Dates/Locations:

April 23rd, Cambridge, MA

April 24th, Durham, NC

April 25th, Indianapolis, IN

April 26th, South San Francisco, CA

April 27th, La Jolla, CA

Automation Topics at the Seminar:

  • Emerson presents DeltaV Discover, the latest automation solution designed for life science laboratory scale development with seamless process transfer to manufacturing.
  • VControl, Applikon's laboratory bioprocess automation solution built on DeltaV Discovery.
  • New developments in Applikon's main bioprocess control systems for mini-bioreactors and process development.
  • Lucullus Process Information Management System (PIMS), a single software solution designed to manage all bioprocess functions and instrumentation from experimental design, planning, execution, data analysis and reporting.

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Wednesday, April 25th, 2018

3:15 - 4:15 p.m.

In this session, participants will learn how SmartFactory Rx is being used by Janssen to improve compression yield.  Deshawn will describe how advanced analytics for monitoring and control are improving process understanding.  Both UVA and MVA statistical process control methods are being leveraged to increase process reliability and to reduce process variability. A dashboard on the shop floor guides the operator's response to operating conditions with prescriptive action. Learn where Janssen is today in their deployment and their vision for using SmartFactory Rx in the future. 

Presented by Deshawn Jordan, Janssen and Ashley Howard, Applied Materials

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Thursday, April 12th 2018

In this live webinar, Dr Marta Ruiz Guillen, USP Development Specialist at 3P Biopharmaceuticals will discuss the methods and results from performing media and feed screening evaluations in ambr® 15 with CHO-S cell line producing monoclonal antibodies and demonstrate the effectiveness of ambr 15 for rapid and robust cell culture process development.

In the development and delivery of high quality therapeutic proteins, high throughput process development tools can real accelerate early process understanding. ambr® 15 cell culture system offers an alternative approach to shake flask or conventional benchtop bioreactors in an automated, multi parallel, high throughput format. The system can be implemented within the Upstream process workflow to generate early process development data at the small scale with very low demands on operator time, set-up components, and improve global costs of development due to the minimum scale the equipment is designed to operate.

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