BTEC Analytical Methods for Raw Materials Testing
Biopharmaceutical manufacturing relies on a wide variety of raw materials, including ancillary reagents for cell culture, components for purification, excipients for formulation, and materials for container/closure and storage. Many of these materials are a potential source of process and/or product variation and require testing to ensure final product quality and safety.
This three day course will provide hands-on training for the most common raw materials testing techniques with specific focus on Inductively Coupled Mass Spectrometry (Chapters <232> and <233>, Elemental Impurities by ICP-MS). Additional laboratory sessions will include the following:
- Identification (ID) by handheld Raman, ID by FTIR (Chapter <197> Spectroscopic Identification Tests),
- Water content via loss on drying and Karl Fischer (Chapter <921> Water Determination),
- Endotoxin testing (<85> Bacterial Endotoxins), and
- Various titrations (Chapter <541> Titrimetry).
These laboratory exercises will focus on interpretation of the United States Pharmacopoeia (USP) — from general chapters to monographs — and how to stay up to date with recent and upcoming changes. Participants will also be introduced to the regulatory guidelines for raw material testing, assessing raw material risk, and phase appropriate testing.