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CMC Strategy Forum (14)

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CMC Strategy Forum North America Summer

Displaying results 1 - 20 of 24

CMC North America 2022 Scientific Program

Scientific Program: CMC North America 2022
Manufacturing Challenges and Strategies for Bispecific Antibody

Speaker Presentation Wu Wen Jin CDER, FDA 2022
Expectations on Potency Assays for Antibody-based Novel Modalities– a Regulatory Perspective

Speaker Presentation Zhang Nailing CDER, FDA 2022
A Potent Solution to a Low Affinity Problem

Speaker Presentation Wilson Morgan INHIBRX 2022
Characterization of Novel Biological Product Modalities - A Regulatory Perspective

Speaker Presentation Rivera Rosado Leslie CDER, FDA 2022
Novel Modalities May Warrant Novel Product Quality Controls

Speaker Presentation Schmiel Deborah CDER, FDA 2022
Cell-Based Potency Assay : Designs and Considerations

Speaker Presentation Kumar Janani Molecular Templates, Inc. 2022
Leveraging a Novel Flexible Facility Concept to Provide Solutions to Current and Future Manufacturing Challenges

Speaker Presentation Christy Charles Lonza 2022
CMC Strategy Forum North America 2022 Summary Infographic

Summary Infographic: CMC Strategy Forum North America 2022
Stability Considerations and Challenges in Autologous Cell Therapy

Speaker Presentation Polson Nolan, Bristol-Myers Squibb Company, 2020
What Is Test Method Qualification?

CMC Summary Paper: CMC Strategy Forum North America Summer 2003
Defining Your Product Profile and Maintaining Control Over It - Part 1 through 4

CMC Summary Paper: CMC Strategy Forum North America Summer 2004
Design and Successful Implementation of a Stability Program for Biotechnology-Derived Products

CMC Summary Paper: CMC Strategy Forum North America Summer 2005
Standard Reference Materials for Biopharmaceutical Products: Strategies to Support Product and Method Specifications

CMC Summary Paper: CMC Strategy Forum North America Summer 2006
Quality by Design (QbD) for Biopharmaceuticals

CMC Summary Paper: CMC Strategy Forum North America Summer 2007
Practical Applications of Quality Risk Management

CMC Summary Paper: CMC Strategy Forum North America Summer 2009
QbD for Biologics: Learning's from the Product Development and Realization Case Study (A-Mab) and the FDA OBP Pilot Program

CMC Summary Paper: CMC Strategy Forum North America Summer 2010
Challenges and Considerations for Multiproduct Facility Design and Control for Biologics

CMC Summary Paper: CMC Strategy Forum North America Summer 2011
Drug Product for Biological Medicines: Novel Delivery Devices, Challenging Formulations and Combination Products - Part 1 and 2

CMC Summary Paper: CMC Strategy Forum North America Summer 2012
Biological Product-specific Reference Standard - Best Practices - Part 1 and 2

CMC Summary Paper: CMC Strategy Forum North America Summer 2013

Displaying results 1 - 20 of 24

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