PC to CPV Late-Phase Tech Transfer

Abstract: Late‑phase program transfers often arrive with years of thoughtful process characterization (PC), carefully defined control strategies, and a deep scientific rationale that sponsors are rightly committed to preserving. In this webinar, attendees will hear from Catalent’s Danielle Wittenwyler, PhD, who will outline how Catalent protects and upholds existing PC as the foundation for a seamless tech transfer, ensuring that the design space, risk assessments, and process understanding remain intact as a program moves toward process validation and continued process verification (CPV).

Wittenwyler will discuss Catalent’s structured approach for translating sponsor‑generated PC into its manufacturing environment in Madison, Wisconsin, maintaining parameter criticality and control‑strategy intent. She will highlight how the team systematically assesses gaps and defines risk‑based, fit‑for‑purpose supplemental activities to ensure alignment across scale, equipment, consumables, and analytical methods. Finally, she will show how PC directly informs validation acceptance criteria and serves as the backbone of an inspection‑ready CPV monitoring framework.

Attendees will gain practical insight into how Catalent-Madison safeguards the value of foundational process design efforts, minimizes rework, and provides continuity from characterization through commercial readiness, ensuring that a process story is carried forward instead of rewritten.

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