Biopharmaceutical therapeutics (biotherapeutics) such as monoclonal antibodies (mAbs) treat or prevent a wide variety of disease states, including cancers, autoimmune, degenerative and cardiovascular diseases. Biotherapeutics manufacture necessitates the use of very large cultures of mammalian cells followed by extensive purification steps (using a combination of unit operations in series), under Good Manufacturing Practice (GMP) conditions. These purification consumables incur the bulk of manufacturing costs - chromatography purification accounts for over 50% of the cost of biotherapuetics . Current processing strategies are limited due to the platform technologies available, which have only seen incremental improvement over the last 20 years, and are now run close to their physical limits to accommodate increasing amounts of product from high titer fermentations. This requires voluminous tanks and significant clean room floor space for larger product pools and buffer volumes, all translating into infrastructural limitations . The linking of standardised process to clinical result, and so commercial success, has made the industry highly risk adverse to the adoption of new technologies. Yet pressure to adopt new technologies is increasingly driven by the need to better understand processes and build in flexibility to both de-risk manufacture and be able to adapt to uncertainties in progression through the clinical trial process and patient population size. This is against a background of payers worldwide becoming more price sensitive and the development of more complex, next generation proteins for gene and T-Cell therapies. Therefore, the biopharmaceutical industry is fast opening up to the adoption of new technologies, as evidenced by the increasing use of disposable equipment such as single-use bioreactors (SUBs; >50% increase in use since 2006 ), which increase facility flexibility and reduce validation costs.
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.
