USP offers on-demand learning resources addressing a range of topics related to biologics standards and development processes. Many of the courses and recordings are complimentary and can provide valuable information to support your biologics development and manufacturing strategies.
Bioassay Workshop Recordings
- Principles and Practices for Bioassay Standards
- Development of In Vitro Functional Bioassays for Potency and Immunogenicity Screening of Cell and Gene Therapy Products: Challenges and Opportunities
- Challenges of Bioassay Development and Specification Assessment for Biosimilar Product with Multiple Mechanisms of Action
- Analytical Bridging: How to Cross on the Wire Stretched Between Two Bioassay Methods?
- Setting the Acceptance Limits for Bioassay Validation
Peptide and Oligonucleotide Workshop Recordings
- Coming soon!
On-Demand Courses
- Bioassay Design, Development and Validation (fee required)
- Characterization and Biological Relevance of Protein Aggregates and Other Particles 100 20,000 nm in Size (Sub Micron and Subvisible) (complimentary)
- Residual Host Cell Protein Measurement in Biopharmaceuticals (fee required)
- Residual DNA Testing (On-Demand) (fee required)
- USP Standards that Support the Development and Characterization of Biologics (complimentary)
- Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies (complimentary)
- Evolution of Specifications and Analytical Methods During Synthetic Peptide Drug Development (complimentary)
- N-linked Glycan Analysis: New Compendial Procedures and Associated Reference Standards (complimentary)