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Interactions of Parenteral Biopharmaceutical Products with Drug Delivery Device Components; Effect on Stability and Activity
Thomas Schoenknecht
Gerresheimer Bünde GmbH Erich-Martens-Strasse 26-32, D-32257 Bünde, Germany
Tel:
+49
5223 164 242 Fax:
+49
5223 164 316 |
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Biography Dr. Thomas Schoenknecht is Director Product Development/Product Management at Bünder Glas GmbH. He gained a Diploma in Chemistry of the University Goettingen, Germany and in 1993 a Ph.D. in biophysical chemistry from the University Goettingen and the Max-Planck Institute for biophysical Chemistry.
Since 1994 he held different key-positions in pharmaceutical industry in technology development and product management as well as business development.
Since April 2006, Dr. Schoenknecht has been working in the Gerresheimer pharmaSystems division for Bünder Glas in Product Management and Business Development. Dr. Schoenknecht is head of product management and product development for the whole glass based product portfolio (containing sterile (RTF®) and non-sterile syringe systems as well as syringe accessories) within Gerresheimer pharmaSystems.
He is member of the PDA (Chair of the PDA Pre-filled Syringes Interest Group), the AAPS, the Arbeitsgemeinschaft für pharmazeutische Verfahrenstechnik (APV) and active as member in different injection device related ISO/TC 84 working groups and the NA 063 committee of the German Institute for standardization, DIN, Berlin.
Company Profile The Gerresheimer Group is one of the leading international suppliers of high-quality packaging and system solutions made from glass and plastic, especially for the market segments of pharmaceuticals and cosmetics. Gerresheimer manufactures in 17 locations in Europe and America and employs 5,300 people worldwide. Sales total around Euro 530 m, of which almost three quarters are achieved outside Germany. The pharmaceutical product range consists of glass packaging products as well as pharma systems. |
Abstract
Biopharmaceutical drugs are known as very sensitive ones, which needs a defined environment in order to hold them stable in solution. The use of a drug delivery device such as a pre-fillable syringe brings different materials such as glass, rubber and silicone in contact with the drug active molecules. The talk will highlight the potential interactions observable within a pre-filled syringe based drug delivery device and describes latest production techniques already implemented to solve the related problems.
Topics to be highlighted in detail/subtitles of the presentation:
- Effect of Tungsten and other heavy metal ions on the activity and stability of drug molecules, way to avoid this contamination - pH-shift related issues and stabilization of WFI syringes - Loss of activity due to silicone contamination and ways to reduce the quantity of free silicone.
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