Avid Bioservices approved as PER.C6 CMO
first pre-approved US contract manufacturer of its PER.C6 human
cell lines.
The two companies have approved California-based Avid Bioservices to manufacture proteins and antibodies for the licensees of its PER.C6 technology on the US West Coast.
It joins an established vendor network was created in 2006 with the aim of developing and providing high-quality biotechnology tools and services specifically tailored to this novel technology.
Current members include Invitrogen, which is offering PER.C6 licensees its clone generation services.
Avid provides a range of good manufacturing process (GMP) manufacturing services for the biopharmaceutical industries, including cell banking, stability testing, commercial and clinical product manufacturing and purification, bulk packaging and filling, and also provides process development activities, including cell line optimisation, analytical method development and product characterisation.
Karen King, president of DSM Biologics said of the new arrangement: "We are confident that Avid's excellent reputation and service level will be instrumental in making the PER.C6 technology available to licensees on the west coast, bringing our technology to a wider regional base as we continue to grow globally."
The PER.C6 technology was developed by Dutch biotech company Crucell for the large-scale manufacture of biopharmaceutical products such as recombinant proteins, including monoclonal antibodies.
DSM Biologics is Crucell's alliance partner for the technology, with exclusive rights to license the cell line as a production platform.
Its advantages over conventional production technologies include its "excellent safety profile, scalability and high productivity levels under serum-free culture conditions".
Only last week the companies reported a new record yield using PER.C6 of 27 grams of IgG antibody per litre, bettering the 15 gram per litre mark that was reported earlier in the year.
Moreover, it is the only human cell line-based technology and the only one with a dedicated set of experts to provide technical support to the licensees, of which there are now around 30 around the world, the firms said.
This corner of the industry holds much promise.
A recent Business Insights report predicted that the contract biomanufacturing market, which was worth about $2.5bn in 2006, will expand by around 5 per cent a year through to 2011.
The study estimated that the developmental pipelines of pharmaceutical firms' contain around 500 candidate protein drugs and a further 50 protein-based medications that have entered clinical trials.
In addition, the current global market for proteins and monoclonal antibodies is worth between $50bn and $60bn and is estimated to grow to $200bn by 2020, according to a Reuters report.