Biologics Tech Transfer & Validation at Scale: A Better Path toCGMPWebinar
Join us for our upcoming webinar
As biologics grow more complex and development timelines accelerate, the margin for error in tech transfer and validation continues to shrink.
Moving from development into clinical and commercial manufacturing introduces new challenges. Process knowledge does not always transfer seamlessly. Differences in equipment, facilities, and organizational interpretation of data can introduce variability. What appears robust at development scale may behave unpredictably at commercial scale without clear alignment on control strategy, scale-down models, and data handoffs.
These gaps can emerge as isolated failures or as cumulative issues that affect timelines, process performance, and confidence heading into PPQ.
This webinar examines where breakdowns most commonly occur during scale-up, site transfer, and validation, and how experienced teams anticipate and mitigate these risks. From early planning through PPQ and continued process verification, we will explore practical approaches to transferring knowledge, aligning teams, and maintaining control as programs progress.
What You Will Learn
- Where tech transfer and scale-up typically introduce risk, and how to identify it early
- How to translate development process knowledge into consistent performance across scale and site
- Unparalleled quality and operational excellence
- What PPQ and continued verification generally require to support efficient, compliant progression
- How stage-appropriate process characterization informs validation strategy
- The role of comparability and analytical method transfer inCGMPreadiness
Who Should Attend
This webinar is designed for professionals involved in biologics development and manufacturing, including:
- Process Development and MSAT leaders
- Validation and Quality professionals
- Technical Operations and Manufacturing teams
- Program and CMC leadership overseeing scale-up and PPQ readiness
