PLANTATION, Fla. and MONTREAL, June 2, 2011 /PRNewswire/ --Goodwin Biotechnology, Inc. (GBI), a full service CMO focused on process development and GMP manufacturing of cell culture derived biopharmaceuticals, and Alethia Biotherapeutics, Inc., a biotechnology company focused on monoclonal antibody development with a very sensitive and highly disease-tissue specific proprietary target discovery platform, announced a collaboration on the development of a mammalian cell line-based IgG monoclonal antibody project that is anticipated to make a significant impact in the treatment of selected cancers. Terms of the agreement were not disclosed.
"AB-16B5 is a humanized IgG2 monoclonal antibody which targets secreted clusterin for the inhibition of cancer-associated epithelial-to-mesenchymal transition (EMT), and it has shown positive pre-clinical results in representative cancer models derived from various solid tumors," notes Mario Filion, Ph.D., Executive VP and CSO at Alethia Biotherapeutics. "And, we are pleased to select GBI as our development and GMP manufacturing partner for our first product candidate."
"We at GBI would like to echo that comment. We are pleased to partner with Alethia Biotherapeutics on this important project," says SooYoung Lee, PhD and Senior Vice President of Operations at GBI. "In the biologics CMO niche, we were among the first to engineer the concept of 'full integration', which enables us to work with our clients from Proof of Concept through the manufacture of pre-clinical, and clinical trial products. It is a process we termed 'GMPnization'. In other words, we begin with the end in mind. We employ appropriate stringent regulatory and quality systems to supply product candidates during the development cycle from the initial 'production' cell line development all the way through scale up steps leading to the final cGMP compliant manufacturing process and vialing of the final biopharmaceutical product."
About Goodwin Biotechnology, Inc.
Goodwin Biotechnology is a fully integrated cGMP contract manufacturer of monoclonal antibodies, recombinant proteins and vaccines. GBI has the expertise and experience in cell line development, process development and GMP manufacturing of recombinant proteins and antibodies, as well as conjugated therapeutic proteins (e.g., antibodies conjugated to linkers for radioimmune therapy and diagnostics, other antibodies, proteins, chemotoxins, or plant toxins) by leveraging our proprietary conjugation technology. By working with GBI, our clients can enhance the value of their product candidates with clear development and manufacturing strategies and a road map to meet product requirements from the milligram, gram and kilogram range as the product candidates move along the clinical approval pathway. With nearly 20 years of experience as an independent contract manufacturer, GBI has worked with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established biopharmaceutical companies.
About Alethia Biotherapeutics Inc.
Alethia is a privately held, Montreal-based biotechnology company created in 2002. Alethia develops innovative therapeutic approaches in areas of unmet medical needs. The Company is currently focusing its development efforts on cancer-associated epithelial-to-mesenchymal transition, ovarian cancer, and cancer-induced bone loss, three areas for which there are very few therapeutic alternatives. Alethia capitalizes on its ability to identify and validate disease-specific targets for the development of highly focused antibody-based therapeutics.
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SOURCE Goodwin Biotechnology, Inc.