Rapid Tech Transfer of Vaccine Products

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, 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.