BTEC Analytical Methods for Raw Materials Testing Course
In this three-day course, you will learn how to find and interpret regulatory resources for raw materials testing, gain familiarity with harmonization, and learn how to assign risk to raw materials in biomanufacturing processes. Hands-on laboratory sessions will provide exposure to various analytical equipment and techniques often required by the United States Pharmacopoeia and European Pharmacopoeia for raw materials.
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 variation and require testing to ensure final product quality and safety. In this three-day course, participants will be introduced to the regulatory guidelines for assessing raw material risk, phase appropriate testing, and where to find this information. In addition, the course will focus on interpreting the different sections of both the United States and Pharmacopoeia and European Pharmacopoeia — from general chapters to monographs — and consider how to stay up to date with recent and upcoming changes. Laboratory activities will introduce participants to various analytical equipment and techniques often required by the pharmacopoeias for raw materials. The highlight of this course will be hands-on laboratory work in which participants will practice interpreting and executing analytical pharmacopoeial methods for some of the most ubiquitous biopharmaceutical raw materials and tests.