From PC to CPV: Preserving Process Knowledge Through Late‑Phase Tech Transfer

Late-phase tech transfers bring years of valuable process characterization that sponsors want to protect. In this webinar, Catalent’s Danielle Wittenwyler, PhD, will share how teams can preserve existing process knowledge while translating it into a new manufacturing environment. Learn how a structured, risk-based approach supports seamless transfer, validation readiness, and a strong foundation for continued process verification (CPV).

Register Free: https://www.biopharminternational.com/bp_w/pc_to_cpv

Event Overview:

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.

Key Learning Objectives

• Understand how existing process characterization (PC) is preserved and translated during late‑phase tech transfer.
• Learn how to build an inspection‑ready PPQ and CPV framework rooted in sponsor‑generated data.
• Recognize when targeted, risk‑based bridging is appropriate—and how to minimize rework.

Who Should Attend

• Chief scientific officers
• Process development scientists
• CMC engineers
• Upstream development scientists
• VP and director levels in biologic development, bioprocessing, biomanufacturing, bioproduction, and process development

Speaker:

Danielle Wittenwyler, PhD
Senior Principal—Process Development, Drug Substance Lifecycle
Catalent

Danielle Wittenwyler, PhD, is a principal scientist in process development at Catalent who focuses on the drug substance lifecycle. She holds a bachelor of science in chemistry from Truman State University and a doctor of philosophy in organic chemistry from the University of Wisconsin–Madison. With nearly a decade at Catalent, Wittenwyler has extensive experience supporting late‑phase and commercial programs, including process characterization, tech transfer, and continued process verification. Her work focuses on building robust, science‑based strategies that sustain processes across the product life cycle.

Register Free: https://www.biopharminternational.com/bp_w/pc_to_cpv