Successfully scale your biotherapeutic characterization methods

Analytical methods are major quality control and integrity tools for biotherapeutic drug development. Transferring these methods to one or more receiving sites or scaling them during the drug development process or post-approval is a typical, yet critical activity to meet drug development timelines. Therefore, method transfer and scaling activities must be managed effectively.

In this webinar, we will cover:

Key learning objectives

• Key factors of method transfer and modernization
• The options and guidelines listed in the FDA guideline and USP <621>, <1224>
• Tips and tricks that ease the burden of scaling and transferring methods

Who should attend?

• Method development scientists and anyone involved in optimizing/modernizing methods.

Certificate of attendance
All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.