New case study released: Bringing the Manufacturing Process to Life Adapting from Terminal Sterilisation to Aseptic Manufacture
The integrated Technical Arcinova Team (Production, Microbiology, Quality Control and Quality Assurance) are able to apply their knowledge and expertise to guide a new innovative product from development to Phase 1 first in human trials (FIHT). This case study illustrates how Arcinova are providing advice and support to the customer to overcome multiple challenges which have been identified during the process design and subsequently, the manufacture and testing of the clinical product.
Our customer (a UK based University) has developed an innovative ophthalmic gel product containing no preservatives by using a laboratory manufacturing process. The process involves the use of bespoke mixing equipment and analytical methods. During initial development the product was to be terminally sterilised however after evaluating various terminal sterilisation techniques it was deemed that the product was not suitable for terminal sterilisation. The challenge was to guide the customer and develop their process to overcome the obstacles associated with aseptic manufacture to produce a GMP compliant product for use in FIHT.
Developing an aseptic manufacturing process for a sterile ophthalmic product has been very challenging and required innovation, creativity and problem solving solutions. Looking to the future, Arcinova are in a position to complete technical batch manufacture which will test all decisions which have been made up to this point. Following on from the technical batch manufacture, stability studies will be initiated leading to clinical manufacture in 2021.
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