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).
Products and Services
Exondys 51 (eteplirsen) for the Treatment of Duchenne Muscular Dystrophy (DMD)
Solithera (solithromycin) for the Treatment of Community-Acquired Bacterial Pneumonia
Fujifilm Diosynth Biotechnologies has announced that it has commissioned on time its new mammalian cGMP Cell Banking Facility (CBF) at its Billingham, UK site.Read more
Fujifilm Diosynth Biotechnologies has added another licensed product to its list of commercial biopharmaceutical products, following the announcement that ThromboGenics' has received FDA approval for the launch of JETREA® (ocriplasmin) in the USA for the treatment of Symptomatic Vitreomacular Adhesion (VMA).Read more
Fujifilm Diosynth Biotechnologies Partners With Piramal Healthcare to Produce Antibody Drug Conjugates
Fujifilm Diosynth Biotechnologies has announced it has entered into a strategic alliance with Piramal Healthcare UK, whereby the two parties will offer the seamless contract development and manufacture of antibody drug conjugates (ADCs), a growing niche in the development of biopharmaceuticals.Read more
Fujifilm Diosynth Biotechnologies has announced it is further increasing its contract process development and manufacturing capabilities through the expansion of its services in mammalian cell line development / process development, and the addition of a new multiproduct cGMP facility at its Billingham, UK site.Read more
Fujifilm Diosynth Biotechnologies has completed the first phase of a £3m ($4.5m) investment in new equipment and laboratories at its Billingham, UK site.Read more
Fujifilm Diosynth Biotechnologies and ContraFect Corporation Announce Development and Manufacturing Collaboration for Novel Anti-Staph Biologic
Fujifilm Diosynth Biotechnologies and ContraFect Corporation have announced that they have signed a contract to support the process development and cGMP manufacture of CF-301Read more
Fujifilm Diosynth Biotechnologies is expanding its existing contract manufacturing capabilities with the addition of a 1,000l Xcellerex® single-use bioreactor to its RTP, North Carolina facility. This expansion reinforces the commitment to lead the global biologics CMO industry through contiRead more
Fujifilm Diosynth Biotechnologies has been announced as the new name for the former Merck BioManufacturing Network (known as MSD BioManufacturing Network outside the US and Canada) following completion of its acquisition today by FUJIFILM Corporation of Japan. As previously announced, tRead more
Fujifilm Corporation and Merck, known as MSD outside the US and Canada, have announced that they have entered into a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a leading provider of contract manufacturing and development services for the biopharmaceutRead more
Nuron Biotech has selected the Merck BioManufacturing Network in the UK to manufacture large-scale GMP clinical supplies of NU100 and undertake process validation leading to long-term commercial operations. NU100 is a proprietary recombinant human interferon beta compound being developed for theRead more
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