CPhI Webinar Series

Rapid Tech Transfer of Vaccine Products

February 24th, 2022 4pm CET / 10am EST / 9am CST

What will this webinar address?

The compressed timelines for technical transfer of COVID-19 projects were unprecedented and offered opportunities to identify and reflect on the unique capabilities required to meet these timelines, as well as the best practices applied to result in the fastest path to GMP production and supply reliability.

This webinar is an opportunity for pharmaceutical companies to better understand how the selection of the right CMO is key not only save cost, but also time.

Join us to learn more about why the following criteria are so important when selecting a CMO:

  • Responsive and Expansive Supplier Networks
  • Global Manufacturing and Regulatory Experience
  • Collaborative Decision Making
  • Experience and Agility
  • Scientific Expertise
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Wendy Saffell-Clemmer

Senior Director, Global Pharma Business Operations & BPS R&D
Baxter


Wendy Saffell-Clemmer is the Sr Director of the Baxter BioPharma Solutions R&D team and Global Pharma Business Operations. The team offers contract development services for small volume liquid (vial and syringe) and lyophilised products which are manufactured for external clients both at Baxter’s Bloomington, IN, US and Halle, Germany facilities.

Services include formulation development, lyophilisation cycle development, container compatibility and analytical development for small molecules, peptides, proteins, mAbs, ADCs and vaccines. Additionally the team performs analytical method validation, transfer and lifecycle maintenance for our QC group as well as cleaning validation method development and validation.

Wendy has also held roles within Baxter’s Pharmaceuticals business, currently in business operations, and previously, leading global complex analytical chemistry teams performing Extractable and Leachable, Elemental Impurity, Structure Determination by Mass Spectrometry and NMR, and Microscopy Studies. She is the chairperson of the USP Expert Committee Bio 2 – Proteins, a member of the Editorial Board of the PDA Journal, and a member of the Pharmaceutical Technology Editorial Advisory Board.

Frank Kogelberg

Director of Business Development, Contract Manufacturing, Halle/Westfalen, Germany
Baxter


Frank Kogelberg, Director of Business Development, Contract Manufacturing, leads the BPS Project Management Organization at Baxter’s Halle/Westfalen plant in Germany. He has more than 18 years of experience in contract manufacturing and project management.

Before joining Baxter in 2007, Frank gained extensive experience in GMP manufacturing as Head of Manufacturing for advanced therapy medicinal products. Frank is a certified PMP (Project Management Professional) and received his degree in biotechnical engineering at the University of Applied Sciences in Giessen, Germany.

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Overview

Title: Rapid Tech Transfer of Vaccine Products
Date: February 24th, 2022
Time: 4pm CET / 10am EST / 9am CST
Duration: 60 minutes
Cost: Free

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