Two contract manufacturing organizations, Goodwin Biotechnology (GBI) and Coldstream Laboratories, said today they will team up to develop and manufacture antibody-drug conjugates and other bioconjugates, hoping to meet growing market demand for ADCs employing highly potent and cytotoxic therapeutic payloads.
Under the collaboration, whose value was not disclosed, GBI will carry out activities within Coldstream’s cGMP platform of services. Those activities include analytical testing, formulation, liquid or lyophilized fill and finish, storage, and shipment of manufactured highly potent bioconjugates.
“These manufacturing activities may be performed for non-GMP proof-of-concept and process development work, as well as manufacturing to support both GLP Tox and cGMP,” Eric W. Smart, Coldstream’s president and CEO, said in a statement. “Our filling batch sizes will vary from tens of non-GMP vials for use in nonclinical, proof-of-concept studies to thousands of cGMP-compliant vials to enable human clinical trials and meet a wide spectrum of client needs.”
Coldstream, which originated at the University of Kentucky's Center for Pharmaceutical Sciences and Technology, offers small-volume, parenteral manufacturing services, as well as mobile-isolator technology to provide an ISO Class 5 environment designed to afford high containment capacity for manufacturing potent, cytotoxic products. Coldstream’s services range from proof-of-concept through to commercial manufacturing.
GBI, which originated with the nonprofit Goodwin Institute for Cancer Research, offers integrated development and cGMP contract manufacturing of monoclonal antibodies, and recombinant proteins and vaccines, as well as ADCs. GBI offerings include cell culture and purification process development, scale-up, GLP manufacturing and cGMP manufacturing services for cell culture-derived biopharmaceuticals.
“The resultant products (ADCs) are designed to provide highly specific targeting of cancer cells, for example, and enhanced cell-killing ability. The result will be improved therapeutic effectiveness with minimal toxicity when compared to traditional therapeutic approaches," predicted Muctarr Sesay, Ph.D., GBI’s vp of process development, in the statement.
GBI, which is owned by India-based Wallace Pharmaceuticals, has established several manufacturing collaborations not only with biopharmas but with research institutions as well. In one agreement reached last year, GBI and the University of Texas MD Anderson Cancer Center agreed to collaborate on process development and GMP manufacturing of a cancer-fighting fusion protein consisting of a vascular endothelial growth factor and the recombinant toxin, Gelonin (rGel), conjugated to a DOTA chelator.