About

Wendy Saffell-Clemmer is the Director of the Baxter Biopharma Solutions R&D team. 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. She volunteers as a member of the USP Expert Committee for Biological Analysis-General Chapters, the USP Expert Panel for Protein Measurement, and the AAPS Biosimilars Focus Group Steering Committee.

Contributions

PREFILLED SYRINGES

A RISK MANAGEMENT APPROACH TO PREFILLED SYRINGE SELECTION FOR BIOTECHNOLOGY PRODUCTS

Prefilled syringes are becoming an increasingly attractive option for complex biotechnology products, not least because of the savings in product volume compared to vials. There is now a wide range of options to suit different requirements which can make product selection a challenge. Wendy looks at what advances are currently being made.