Biography
Dr. Dirk Sobotta is Product Manager Daikyo Crystal Zenith® at West Pharmaceutical Services
He studied biology and received his PhD from the Justus-Liebig University in Giessen, Germany in 1999. After several years of business experience at major Biotechnology and Pharmaceutical companies, he joined West Pharmaceutical Services in 2007 as Product Manager Daikyo Crystal Zenith®.
In his position he is responsible for all product management and business development activities related to Daikyo Crystal Zenith® based products.
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Abstract
In the recent years a trend can be observed to move from vials to prefillable syringes as the container closure system of choice for liquid biopharmaceuticals.
Next to prefillable syringes made from glass plastic prefillable syringes like Daikyo Crystaline RUTM are evolving as a separate primary packaging product category. This syringe system helps maintaining drug stability by nearly eliminating the interaction between the drug and the packaging materials.
A unique feature is the fact that this system works without any siliconization. Previous studies have shown that silicone oil can induce aggregation of proteins by interacting directly with the surface of proteins (Middaugh C.R. 2005).
This was further investigated in prefillable syringe systems using a marketed monoclonal antibody based drug, Orencia. Orencia (abatecept) is used to treat adults with moderate to severe rheumatoid arthritis. Syringe systems used for these studies were silicone-free Daikyo Crystaline RU plastic syringe system and siliconized glass syringes. The difference in optical density measurements at 350 nm before and after shipment was used to monitor protein aggregation. The extent of aggregation was three fold higher for siliconized glass compared to Daikyo Crystaline silicone-free syringes.
In another study, the impact of agitation was also measured by the difference in optical density measurements at 350 nm. In this case, the optical density was 1.3 fold higher for siliconized glass syringes. This difference suggests silicone oil induced aggregation.
The amphipathic nature of protein molecules results in their adsorption to a wide variety of surfaces. This is potentially a significant problem in biotechnology due to both loss and destabilization of proteins (Middaugh C.R. 1992). Adsorption phenomena were investigated in prefillable syringe systems using Lactic Dehydrogenase as a model protein.
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