BPD "Raw Materials - Qualification, Characterization and Control" Symposium
Variability in raw materials has the potential to decrease manufacturing productivity and cause shifts in product quality attributes which may result in impact to the efficacy or safety of the drug substance and drug product. Raw materials used in biological processes range from simple salts and buffers to complex medias and cell substrates. In this symposium, leaders in the industry from U.S. Pharmacopeia, PDA, Biogen, Novo Nordisk and Biologics Consulting will present their views on qualification, characterization, and control of raw materials.
Agenda
12:30 - 1:00 p.m. Registration and Networking
1:00 - 1:10 p.m. Introduction
1:10 - 1:50 p.m. “Qualification of Raw Materials and Cell Substrates for Biomanufacturing”
Maura C. Kibbey, Ph.D., Senior Scientific Fellow, Global Biologics U.S. Pharmacopeia
1:50 - 2:30 p.m. “Raw Material Characterization and Control”
Thomas Matthews, Ph.D., Scientist II, Manufacturing Sciences, Biogen
2:30 - 3:05 p.m. Networking Break & Refreshments
3:05 - 3:45 p.m. “Building Quality into the Supply and Release of Raw Materials”
Presented by Brian G. Keefer, Sr. QA Area Specialist II - Raw Materials Quality, Novo Nordisk Pharmaceutical Industries, LP
3:45 - 4:25 p.m. "Ancillary Materials for Cell and Gene Therapy Products- Regulatory Challenges"
Kamalpreet Arora, PhD, Senior Consultant, Chemistry Manufacturing and Control, Biologics Consulting
4:25 - 4:30 p.m. Closing Remarks / Adjourn
For questions or more information, contact:
Hannah Cole
Program Manager, Science and Technology Development
Science and Technology Development
919-549-8840
| hannah_cole@ncbiotech.org
NC Biotech
15 TW Alexander Drive
RTP, NC 27709