Date: January 20-24, 2020
Location: Hilton San Diego Bayfront, San Diego, CA
Speaker: Jie (Amy) Liu, Scientist IV
Biologics & Biotechnology Laboratory, Global Biologics, United States Pharmacopeia
Development of Standards for Cation Exchange Chromatography Column Qualification
Event date: Monday, January 20, 2020
Time: 12:15 pm
Topic: USP has sponsored several roundtables with stakeholders to identify challenges in biologics development that could be alleviated with standards. Standards for qualification of cation exchange columns were ranked as high priority. We evaluated three new USP monoclonal antibody standards under development using pH gradient and salt gradient CEX methods on columns from different vendors to support selection of a candidate for further development of the CEX column qualification standard.
Speaker: Jim Richardson, PhD
Senior Science and Standards Liaison, Global Biologics, United States Pharmacopeia
USP Standards for Gene Therapy
Event date: Wednesday, January 22, 2020
Time: 8:20 am
Topic: This presentation will provide updated information on existing USP standards relevant for developers of gene therapies, such as General Chapter <1047> Gene Therapy Products as well as General Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products. It will also cover USP's development of new physical reference materials to aid developers of gene therapies.
USP Standards Development for Cell Therapies
Event date: Thursday, January 23, 2020
Time: 9:00 am
Topic: This presentation will provide updated information on existing USP standards relevant to developers of cell therapies, such as General Chapter <1046> Cell and Gene Therapy Products as well as General Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products. It will also cover USP's development of new physical reference materials to aid developers of cell therapies.
Date: January 28-30, 2020
Location: The Mayflower Hotel, Washington DC
24th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products
Booth Location: USP Booth #24
Topic: CASSS is an agile, non-profit scientific organization whose strength is in bringing together professionals from industry, academia and regulatory agencies to solve scientific and technical problems in order to advance the development of biopharmaceuticals. CASSS enables regulatory capacity building, knowledge-sharing and global access by leveraging strategic partnerships, scientific expertise and a diversity of views in all of our activities.
Call for participation in a laboratory study on the analysis of monoclonal antibodies
USP will be releasing three new monoclonal antibody standards soon and is planning a round robin study to expand upon the collaborative testing of these materials to include additional laboratories and analytical methods. The study will include tests from USP Chapter〈129〉Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies (e.g. SEC-HPLC, CE-SDS, oligosaccharides) as well as non-compendial tests (e.g. cIEF/icIEF, MS-based glycan, MW by MS). The opportunity to evaluate the new standards using in-house assays will also be available. If your laboratory is interested in participating in all or part of this study, please contact USP at USPBiologics@USP.org. Deadline is October 1, 2020.
- USP Publishes Monoclonal Antibody Guidelines (Pharmtech)
- New USP Standards for Characterization of Therapeutic Proteins
- Journal of Pharmaceutical biomedical analysis; Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods
- The Role of Public Standards in the Development of Biosimilars
- USP Reference Standards for Residual DNA Testing of Recombinant Biotherapeutics