Resources
-
A Better Understanding of Bioassays: How Suitable are Primary Cell Based Assays for the Evaluation of Product Quality?
Speaker Presentation Cymer Florian F. Hoffmann-La Roche Ltd 2022
-
Universal Assay to Measure CAR T Cell Potency
Speaker Presentation Bambad Cynthia Minerva Biotechnologies 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
-
Bioassays 2022 Summary Infographic
Summary Infographic: Bioassays 2022
-
CMC Strategy Forum North America 2022 Summary Infographic
Summary Infographic: CMC Strategy Forum North America 2022
-
CMC Strategies for Expedited Program Development — Regulatory Perspectives
CMC Summary Paper: CMC Strategy Forum North America Fall 2020
-
Cell & Gene Therapy Products 2022 Summary Infographic
Summary Infographic: Cell & Gene Therapy Products 2022
-
Rational Setting of Vector Copy Numbers in Genetically Modified Cells
Roundtable 10 Notes: Cell & Gene Therapy Products 2022
-
Starting and Raw Materials -Harmonization Challenges, Testing and Control Requirements, etc.
Roundtable 9 Notes: Cell & Gene Therapy Products 2022
-
Phase-appropriate Method Validation
Roundtable 8 Notes: Cell & Gene Therapy Products 2022
-
Developing Process Analytical Technologies (PAT) to Support Advances in Cell Therapy Manufacturing
Roundtable 7 Notes: Cell & Gene Therapy Products 2022
-
Characterization of CAR-T Cell Products – Challenges and Opportunities
Roundtable 6 Notes: Cell & Gene Therapy Products 2022
-
Challenges with Emerging Technologies for CGTP Manufacturing and Single Sourcing
Roundtable 5 Notes: Cell & Gene Therapy Products 2022
-
The Balance Between "Phase Appropriate Specifications" and Preparation for Marketing Authorization in Accelerated Development - Lessons Learned
Roundtable 4 Notes: Cell & Gene Therapy Products 2022