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The 10th Annual Bioassays and Bioanalytical Method Development Conference
Mark Ma1, Christopher Tudan, Dolly Koltchev
11 Amgen Center Dr., Thousand Oaks, CA 91320, USA.
Bioanalysis
|April 1, 2015
Summary
Scientists convened to discuss bioassays and bioanalytical method development trends, innovative technologies, and regulatory updates from the US FDA. Key topics included challenges, future directions, and immunogenicity strategies for biotherapeutics.
Area of Science:
- Biopharmaceutical Development
- Analytical Chemistry
- Regulatory Science
Background:
- The 10th Annual Bioassays and Bioanalytical Method Development Conference convened scientists from industry, regulatory bodies, and academia.
- The meeting focused on current trends, challenges, and future directions in cell-based assays and bioanalysis.
- It ran concurrently with the 15th Annual Immunogenicity for Biotherapeutics meeting.
Purpose of the Study:
- To share and discuss advancements in bioassays and bioanalytical method development.
- To evaluate the impact of new technologies on methodologies and workflows.
- To present regulatory perspectives, including US FDA guidance on bioanalytical method validation.
Main Methods:
- Discussions and presentations by experts from biopharmaceutical, life sciences, regulatory, and academic sectors.
- Evaluation of experiences with innovative technologies and their influence on bioanalytical workflows.
- Review of scientific and regulatory paradigms, including US FDA feedback on draft guidance.
Main Results:
- Exploration of current trends and challenges in bioassays and bioanalysis.
- Assessment of the impact of new technologies on quality, feasibility, outsourcing, productivity, and compliance.
- Update on the US FDA's position regarding bioanalytical method validation guidance.
Conclusions:
- The conference facilitated knowledge exchange on optimizing bioanalytical methods and workflows.
- Emerging technologies and regulatory insights are crucial for advancing biopharmaceutical development.
- Addressing immunogenicity remains a key focus in biotherapeutic research and development.
Keywords:
analytical platformsbioanalytical method developmentbioassaysbioterapeuticsmethod development strategiesmethod validationregulatory perspectivesMore Related Videos
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