Periodic Reporting for period 1 - FAST-BM (FAST-BM: FibroSelect: delivering A Step-change in Biotherapeutic Manufacturing)
Reporting period: 2016-08-01 to 2016-12-31
To reduce the manufacturing cost of biotherapeutics, Puridify has developed an innovative bioprocessing platform technology, FibroSelect, a functionalised cellulose chromatography medium to enable high-productivity, product capture and purification that is economic to operate in a disposable manner. This reduces the cost of: a) process development through more powerful tools and critically b) manufacturing through significant reduction in purification consumables costs and ancillary costs such as process validation and buffer usage. This facilitates cost effective manufacture of a wide range of biosimilars and novel biomolecules. FibroSelect has the potential to reduce biotherapeutics manufacturing costs and open up new processing strategies to maximise the output of existing and new facilities. This will play an important role in widening patient access to expensive drugs, and unlock new processing opportunities for “difficult-to-purify” products. Puridify completed a Phase 1 study in order to undertake a detailed investigation of potential routes to market for the platform FibroSelect technology. The expected outcome is a detailed business plan, concurrently giving sufficient information to drive submission of a Phase 2 application to assist the launch of FibroSelect into EU and global marketplaces.
Specific objectives for the feasibility study:
a) Market assessment and prioritisation – to develop early revenue streams to build value whilst partners for large scale commercialisation are identified;
b) Regulatory requirements – to ensure production is in-line with needed standards, and to understand how to best service the regulatory needs for continuous supply (c. 25 years) to the largest customers;
c) Business Models & Exploitation Strategy – to identify scaling partners needed to reach the largest consumers, and the contractual agreements that will underpin these business relationships;
d) Supply chain assessment – to identify reliable suppliers to enable scale-up activities.
Key outputs are a Feasibility report, including a business plan, plus a completed Phase 2 application.
The output of the project is this report which provides a route forward for Puridify to drive towards commercialisation with while establishing a base to apply for follow on funding from the Phase II stage of the SME instrument.
FibroSelect will be the industry’s first true disposable system for biotherapeutic processing and purification. It’s potential to deliver step-change improvements in bioprocessing has been recognised by leading manufacturers of biotherapeutics, who have expressed strong desire to incorporate FibroSelect into their process development once proven via ongoing evaluation studies against their existing platforms.