News

Avecia adds Formulation Studies to its portfolio of services

Date: 09/06/2008

Tees Valley, 9th June 2008 : Avecia Biologics has announced that it has created a new Formulation Development capability based at its Tees Valley, UK laboratories to improve its service offering to customers. Using Avecia’s knowledge and experience built up over the past 10 years of biologics development work, the new unit will bring together biochemical, bioanalytical and biophysical techniques.

Formulation studies are fundamental to ensuring a stable and effective product. The complex nature of most biological molecules including properties such as aggregation and stability, makes the development and implementation of a structured and carefully designed programme essential. This must be done early in the development life of a product to gain maximum benefit from clinical studies and avoid late-stage changes in formulation or a product that fails to deliver its expected effect. Such failures can fundamentally undermine the success of earlystage biotechnology companies.

The company says the new capability will offer real time, cost and technical advantages for its customers:

· The process development and analytical team will quickly build an un-paralleled knowledge of the behaviour of the target biologic – knowledge that is invaluable in
implementing and customising a formulation development programme.

· By incorporating formulation studies directly into the Avecia process development programme, aligning both in parallel in a highly iterative process, the overall development timeline through to the clinic can be minimised.

· The close link between process and formulation ensures the impact of inevitable process changes on potential formulations, can be understood and quickly addressed.

Dr Stephen Taylor, Business Director, says “we hope and expect that this new service in formulation studies will offer additional value to our customers, particularly those at an early stage of clinical development”.

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