ACS 239th National Meeting, Biotechnology Division
California, CA (USA), March 24, 2010
Gerresheimer AG
The Moscone Center
California, CA (USA)
Date
Wednesday, March 24, 2010, 10:50 am
Speaker
Dr. Arno Fries
Director Product Management Tubular Glass
Gerresheimer Bünde GmbH
Title
Compatibility of Biopharmaceuticals with Pre-filled Syringes: What Needs to be Considered?
Abstract
Container closure compatibility of therapeutic products is a regulatory requirement to protect potency, efficacy and safety of active ingredients. In pre-filled syringes a range of materials gets in immediate contact with sensitive biomolecules: silicone oil, tungsten, elastomer closure, plunger, glass and for staked needle syringes adhesive as well as needle. This presentation provides an overview of strategies and processes developed for pre-filled syringes to mitigate stability risks for sensitive biopharmaceutical formulations. The focus is placed on alkalinity, silicone oil and tungsten as sources of incompatibilities. Surface treatment methods to stabilize pH, baked-on siliconization technologies to reduce silicone oil levels and tungsten-free production techniques to avoid tungsten leachables are outlined. How partnerships between biopharmaceutical companies and manufacturers of pre-filled syringes achieve best results for product stability is demonstrated.
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