PTSM: Pharmaceutical Technology Sourcing and Management
The latest pacts from the pharmaceutical supply chain.
Exton, PA (May 21)—Morphotek, Inc. (www.morphotek.com), an US subsidiary of Eisai Co., Ltd. (Tokyo, www.eisai.co.jp), entered into an agreement with CMC Biopharmaceuticals (Copenhagen, Denmark, www.cmcbiopharmaceuticals.com) for the development, GMP manufacturing, and regulatory documentation support of MORAb-028, a therapeutic antibody targeting advanced melanoma and other cancers. MORAb-028 is a human IgM monoclonal antibody that specifically recognizes a cell surface antigen overexpressed on a significant fraction of metastatic melanoma, brain cancers, and non-small cell lung carcinoma. MORAb-028 is being prepared to enter clinical evaluation in 2008.
Oss, Netherlands (May 16)—Organon (www.organon.com) entered into a collaborative agreement with Medarex, Inc. (Princeton, NJ, www.medarex.com) to develop and commercialize human antibody therapeutics for treating cancer and autoimmune disorders. The companies will use Medarex's "UltiMAb" human antibody development system and will share all development and commercialization responsibilities for any antibody-based therapeutics that result from the collaboration.
Pasadena, CA (May 15)—Jacobs Engineering Group (www.jacobs.com) received a contract from Biogen Idec (Cambridge, MA, www.biogenidec.com) to provide engineering, procurement, validation, and site-support services for a cell-culture manufacturing facility in Hillerod, Denmark. The facility, the first of its kind in Hillerod, will produce the multiple sclerosis treatment "Tysabri" (natalizumab). The facility is scheduled for completion in 2009.
Goettingen, Germany (May 15)—Sartorius (www.sartorius.com) signed a new supply agreement with Thermo Fisher Scientific Inc. (Waltham, MA, www.thermofisher.com). The agreement covers the reciprocal supply of products for biopharmaceutical process applications between Sartorius and TC Tech Corp. (Maple Plain, MN, www.tc-tech.com), an affiliate of Thermo Fisher. TC Tech will supply Sartorius with disposable process containers through 2007 and with disposable process containers assembled with Sartorius filter capsules until 2012. Sartorius will continue to supply TC Tech with filter units for an additional five years.
Chalfont St. Giles, United Kingdom (May 3)—GE Healthcare (www.gehealthcare.com) completed a license agreement with NorDiag ASA (Bergen, Norway, www.nordiag.no) that gives NorDiag access to GE patents for the biomagnetic isolation of nucleic acids. The agreement gives NorDiag the rights to isolate and purify nucleic acids using GE's proprietary magnetic separation technology
Morrisville, NC (May 2)—Diosynth Biotechnology (www.diosynthbiotechnology.com) signed a process-development and CGMP production agreement with VGX Pharmaceuticals (Blue Bell, PA, www.vgxp.com). Diosynth will develop a process to produce clinical trial material for VGX's biological therapeutic drug candidate VGX-100.
Naarden, Netherlands (May 1)—BAC BV's (www.bac.nl) "CaptureSelect" custom affinity ligands were selected by Sanofi Pasteur (Lyon, France, www.sanofipasteur.com) for vaccine purification. CaptureSelect ligands are manufactured using a high-yield, animal-free, yeast-based expression system. They offer high stability and specificity for the process-scale purification of some vaccine products.
Lenexa, KS (May 1)—CyDex, Inc. (www.cydexinc.com) licensed its "Captisol" technology to Proteolix, Inc. (South San Francisco, CA, www.proteolix.com) for use with PR-171, proteasome inhibitor that could treat certain cancers. Captisol improves water solubility, bioavailability, and complexation characteristics of insoluble or unstable drugs. The agreement gives Proeolix global rights to Captisol to formulate PR-171.
Midland, MI (May 1)—Dowpharma (www.dowpharma.com), a business unit of Dow Chemical Company (www.dow.com), licensed its "Pfenex" expression technology to VGX Pharmaceuticals (Blue Bell, PA, www.vgxp.com). VGX plans to use the technology to produce a proprietary therapeutic protein for cancer therapy. Pfenex produces large yields of soluble, correctly folded therapeutic proteins, thus avoiding the refold step. The proteins produced also are easy to handle and enable a clear path through the purification process, according to Dowpharma.