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pAVEway™: A Novel Platform for the Advanced Production of Protein Therapeutics
Belasis Avenue,
Billingham,
TS23 1LH County Durham,
United Kingdom
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.
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.
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.
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.
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:
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.
The following additional services are offered to reduce complexity and risk of multiple suppliers:
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.
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).
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Belasis Avenue
Billingham
TS23 1LH
County Durham
United Kingdom
101 J.Morris Commons Lane
Morrisville, NC 27560
California
United States of America