Fujifilm Diosynth Biotechnologies pAVEway™: A Novel Platform for the Advanced Production of Protein Therapeutics

Fujifilm Diosynth Biotechnologies offers a broad range of current good manufacturing practice (cGMP) manufacturing scales, services and experience to accommodate pharmaceutical clients’ specific clinical and commercial needs.

The company’s novel pAVEway™ technology is designed to provide efficient expression of proteins and brings clients’ products to clinical manufacture quickly and cost-effectively.

Fast-track biologics process creation and development

The efficient expression of a therapeutic protein in microbial or mammalian cells is often a bottleneck in the production of biopharmaceuticals. pAVEway helps reduce time to clinic and time to market through fast-track process creation and development.

Class-leading fermentation productivity leads to potential for reduced cost of goods, and the technology has been demonstrated across a wide range of biotherapeutic proteins, using a family of expression systems.

Protein expression platform

The pAVEway platform is based on a set of unique protein expression plasmids, which have been developed by Fujifilm Diosynth Biotechnologies. Using DNA looping to control expression, we have created a range of vectors which provide tightly controlled production of the target proteins, whilst allowing very high expression levels.

These vectors are complemented by a range of host strains. By choosing the appropriate combination of plasmid, host strain and fermentation conditions, very high titres have been demonstrated for soluble, insoluble or secreted proteins.

Proven protein production system

pAVEway has a track record for enabling rapid entry into first clinical manufacture from vector construction, and very high fermentation yields have been achieved for a wide range of proteins with over 30 proteins successfully produced using the system.

Biopharmaceutical process development

In addition to Fujifilm Diosynth Biotechnologies’ pAVEway technology, the company’s experience ensures process development is applied appropriately, dependent upon the development needs of customer products at different clinical stages. We offer:

• Microbial and mammalian capability in the development laboratories with multiple fermenters and reactors
• 100l scale pre-cGMP pilot plant for process demonstration and supply of pre-clinical material

Mammalian and microbial cGMP manufacturing

Fujifilm Diosynth Biotechnologies’ process development capabilities are supported by a broad range of mammalian and microbial cGMP manufacturing capabilities at our sites in Billingham, UK, and Research Triangle Park, NC, US.

Together, the company hasmore than 15 years of experience working with 140 complex proteins. The firm has successfully manufactured four approved products, demonstrating the company’s strong track record in navigating the critical path through validation and regulatory approval.

Fujifilm Diosynth Biotechnologies’ facilities have received successful regulatory inspections from all key regulatory agencies.

Biopharmaceutical manufacturing support services

The following additional services are offered to reduce complexity and risk of multiple suppliers:

• cGMP cell banking facilities for production of master and working cell banks
• Buffer screening studies to support downstream process development
• Development of stable product formulations
• Full range of in-house analytical methods
• Full range of stability testing capabilities for drug substance and drug product

Quality and regulatory support for protein expression

To ensure Fujifilm Diosynth Biotechnologies’ customers’ products meet international regulatory requirements, we provide all the necessary quality and regulatory support through an independent quality unit.

• Regulatory support for IND/CTA submission, DMF and CMC as required
• QC analysis and release of raw materials, environmental and water in-process/final, sample retention
• Ownership and use of qualified or validated methods
• Quality agreement followed by routine interactions with customer throughout the programme

About Fujifilm Diosynth Biotechnologies

Formed in April 2011 following the acquisition of MSD BioManufacturing Network, Fujifilm Diosynth Biotechnologies is a leading provider of contract process development and manufacturing services for the biopharmaceutical industry.

The company has more than 800 employees operating from two sites in Billingham, UK (formerly Avecia Biologics) and Research Triangle Park, North Carolina, US (formerly Diosynth Biotechnology).