Uptick in Business
Contractors around the globe are experiencing this uptick in business. Medipolis GMP (www.medipolisgmp.com) recently signed a manufacturing agreement with Evolutec (www.evolutec.co.uk). Pirkko Suhonen, CEO, says, "We know the industry is picking up by the increase in inquiries we are getting. We focus on small-scale microbial production. Our customers tend to be small biotech drug development companies, companies that are finding it easier to raise funds due to the improved financial market."
In August, Agenix (www .agenix.com) signed a contract with Diosynth Biotechnology (www.diosynthbiotechnology.com) to manufacture ThromboView, a diagnostic product that uses radiolabelled antibodies to locate blood clots in the body.
ThromboView is currently in Phase II clinical trials in the U.S. and Canada. Diosynth will provide technology transfer and process development services for this product in 2005 and cGMP material for Phase III clinical trials in 2006.
Diosynth Biotechnology is Organon's third-party contract manufacturing services unit for biopharmaceuticals, and Organon is the human healthcare unit of Akzo Nobel.
Richard Basile, vp marketing and sales at Diosynth, says, "Revenues from our CMO business unit are on the increase, and we are expecting an even more robust 2006/2007. As part of Akzo Nobel and Organon, we have a proven track record in process development and the commercial manufacture of biopharmaceuticals."
Diosynth Biotechnology manufactures commercial products such as Pfizer's Somavert, Organon's recombinant FSH Puregon, and Protein Design Labs' Retavase, as a third-party CMO.
"We have added fill-and-finish services for clinical, and subsequently commercial-stage, products. We are expanding our cell line development and testing services," Basile explains.
"Our manufacturing capabilities already include specialty services for inclusion body processes, expression of baculovirus in insect cell lines, cell-based testing, PEGylation, and perfusion cell culture in addition to the standard biomanufacturing processes."
"Those CMOs with the broadest capability and service offerings, coupled with demonstrated cGMP compliance worldwide and flexible alliances with customers, will be the long-time winners in this industry," Basile continues.
DOR BioPharma (www.dorbiopharma.com) recently entered into a joint development agreement with DowpharmaSM (www.pharma.dow.com) contract manufacturing services for a proprietary oral botulinum vaccine. Dowpharma will provide process development services leading to cGMP production of this vaccine using the Pfenex Expression Technology, a Pseudomonas-based technology.
Dowpharma launched the Pfenex Expression Technology in 2004 for the production of recombinant proteins. DOR BioPharma expects this technology to expedite the production of multiple botulinum toxin serotype antigens from the laboratory to cGMP production. Dowpharma also recently signed agreements with Pfizer and Iomai for use of this expression technology.
Dowpharma, a business unit of The Dow Chemical Company, provides contract manufacturing services to both pharmaceutical and biopharmaceutical companies. "Our revenues are growing due to early adopters moving from feasibility studies into process development. We have also seen a growth in new clients wanting to assess the Pfenex Expression Technology for the current production of their recombinant protein, peptide, and single chain fragments or Fabs. Both large and small companies recognize that investing in advanced process technologies will directly impact their bottom line," says Patrick Lucy, business leader.
The Pfenex system increases the cellular expression of recombinant proteins and peptides while maintaining solubility and activity characteristics, Lucy explains.
"This expression technology enables our clients to achieve higher volumetric and specific expression, while our solvent extraction technology enables us to efficiently separate the target proteins from host cell contaminants. Combined, these technologies provide lower cost of goods and faster process development."
At Cambrex Biopharmaceuticals (www.cambrex.com/biopharma), growth in the business is coming from new clients such as Evolutec, ZymeQuest, and DOR BioPharma, while existing clients such as Tercica, GTC Biotherapeutics, and Nabi Biopharmaceuticals are coming back for repeat business.
Cambex recently completed the first milestone of fermentation and downstream process development for the manufacturing of DOR BioPharma's ricin toxin vaccine, RiVax. The agreement with DOR was signed in January.
Ryan Scanlon, manager, marketing and business development at Cambrex, says, "A robust and diverse number of biopharmaceuticals are slowly, but surely, progressing through the clinic. Late-phase and commercial contract opportunities are still outnumbered by early-phase projects, but the late-phase projects are becoming more plentiful."