Goodwin Biotechnology, Inc. (GBI) and Coldstream Laboratories have entered a collaboration to develop and manufacture high-potency, highly cytotoxic materials, such as small molecules, protein toxins, cytotoxic antibody drug conjugates (ADCs), and other bioconjugates. GBI will collaborate with Coldstream to perform a number of activities using Coldstream's cGMP platform of services, including analytical testing, formulation, liquid or lyophilized fill and finish, storage and shipment of manufactured highly-potent bioconjugates.
Muctarr Sesay, Ph.D., vice president of process development at GBI, remarked, “To address growing market demands for ADCs employing highly potent and cytotoxic therapeutic payloads, it has recently become clear that a collaboration is needed with a company that has high-containment and isolation capabilities relative to the handling, processing, characterization, fill and finish, lyophilization, and storage of these cytotoxic materials. The resulting products are designed to provide highly specific targeting of cancer cells, for example, and enhanced cell killing ability."
Eric W. Smart, president and chief executive officer of Coldstream Laboratories, said, "Our FDA-inspected facility uses mobile-isolator technology to provide an ISO Class 5 environment affording high containment capacity that is well suited for manufacturing potent, cytotoxic products. Our skilled team of experts uses this highly sophisticated facility to safely and efficiently manufacture sterile, potent, drug products. This capability, coupled with the bioconjugation expertise of GBI, will help advance patient care through the delivery of sophisticated potent therapies."