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Process development consultancy and management – a UK Biotech start−up
Problem
A UK biotech start−up with an exciting but highly novel and complex product technology had no manufacturing process to supply material for pre-clinical and clinical studies.
Approach
Eden Biodesign worked in the client’s offices and laboratories to build a thorough understanding of their specific requirements. Eden Biodesign conceptually designed an appropriate manufacturing process, including necessary testing. Eden Biopharm then managed the CMC project team to set up and develop an initial process to produce material, working side by side with both the company management and the lab scientists.
Deliverables
Eden Biodesign first delivered a manufacturing and clinical product summary document. Following client agreement of this summary, a detailed, strategic product development plan was produced. This plan was then implemented with Eden Biodesign managing the Chemistry and Manufacturing Team on a day-to-day basis. Activities included assembling a process development technical team within a University setting, performing process development studies and defining a manufacturing process, which was suitable for transfer to a contract manufacturing organisation for clinical manufacture. An analytical testing package for a product consisting of a complex mixture of biological molecules was also established.
Benefits
The benefit to the client was a documented, developed manufacturing process produced in less time and for less cost than outsourcing the whole process to a CMO. In addition internal staff received valuable training and experience in a range of product development disciplines and critical product knowledge was developed inside the client company. We are client focused enough to know that outsourcing process development to a CMO isn’t always the best option...
