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Challenges Meeting the CMC and Clinical Material Requirements During Gene Therapy Developm...

Clare Blue Ph.D., Director, Biologics / Gene Therapy Development, TDPL Linda Engle Ph.D., ...

Annex 1 and Environmental Monitoring Program – Implementation and Justification

Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi

Unlocking Next-Generation Manufacturing with PAT and Automated Intelligent Control

Martin Gadsby, Vice President, Optimal Industrial Automation Ltd

Supplier Qualification for Single-Use Technology

Scott M. Wheelwright, PhD, Chief Operating Of Office BioInno Bioscience Co., Ltd.

Drug Delivery Strategies For Oral Pediatric and Geriatric Products

Carsten Timpe, Technical R&D Expert Scientist Angela Dischinger, Group Head in Formula...

Reasons to Buy into a Joint Auditing Program

Pall Corporation


Featured Articles

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey DoyleManager, PAT Projects in the Process Analytical Sciences Group
Paul JeffersManager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’NeillAnalytical Chemist
Pfizer

Trends in Single-Use Mixing Technologies and Insight into Pall and Lonza Ibex® Solutions

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies

Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington

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Careers

Amgen is a Company that Cares about People, I Feel Genuinely Listened to Here

Jason Rudd, Amgen, Statistical Programming Manager

Inspiring the Next Generation at Bristol Myers Squibb

Elizabeth Jurica, Bristol Myers Squibb, Principal Scientist

A Great Working Atmosphere, Strong Collegial Relationships, and Opportunities to Grow at Lonza

Vijetha Bhat, Lonza, Houston,Texas, Scientist, Research and Development

At Bayer We Foster an Environment of Openness and Understanding Not Pity

Jürgen Schrapp, Bayer, Head of R&D Procurement

The Best Thing About Evotec, Without Question, Is The People

Stuart Flanagan, Evotec, Group Leader

At Boehringer Ingelheim, I am a Molecular Architect…

Alexander M. Haydl, Boehringer Ingelheim Germany, Head of Late-Stage Development Laboratory and Product Owner of Digital Process Development

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Headline News

Ultomiris approved in Europe for the treatment of adults with generalised myasthenia gravis


Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age


FDA Approves Lilly’s Retevmo® (selpercatinib), the First and Only RET Inhibitor for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type


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Upcoming Webinars

Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Kevin L. Williams, Microbiological Test Development at bioMérieux, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza 
02nd February 2023


Harmonized Manufacturing Network For Sterility Assurance

Presented by Frederic Ayers, Advisor, Global Quality Systems at Eli Lilly and Company
06th February 2023


Safety Evaluation on Extractables and Leachable

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Tino Otte, Head of Sales & Consulting at Intertek
25th October 2022


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Past Webinars

Continuous Bioprocessing Solutions Webinar Series Part II

Presented by Moderator: Kevin Marino, Presenter: Jon Petrone
23rd May 2017


Evolve Manufacturing Processes by Implementing Disruptive Technologies

Presented by Presented Yuyi Shen, Associate Director and Head of Development & Manufacturing at Bolt Biotherapeutics and John Cyganowski, Director of Manufacturing Sciences and Technologies Downstream Americas for MilliporeSigma
19th November 2018


Viral Safety by Design for Cell and Gene Therapy Products

Presented by Mark Plavsic, Chief Technology Officer at Lysogene and Archie Lovatt, Life Sciences Biosafety Scientific Director at SGS
24th May 2019


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Featured Companies

 

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Featured Video

At Pall we help you select the process model that’s perfect for you. Ensuring it’s adapted to meet your precise needs and assembled flawlessly, ready for the future, from day one.

There’s no kit for the perfect biotech process. Until now.

 

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Technical Papers

Lifetime study for JSR Amsphere A3 – protein A resin


Caustic Stability of Amsphere A3 : Cycling Study with 0.5 M NaOH


Amsphere TM A3


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Featured Products

Decrease Cleaning Validation Time and Resources


AdvantaPure


Amsphere™ A3 Protein A Resin – JSR Life Sciences


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