Goodwin Biotechnology, Inc. (GBI) and Coldstream Laboratories, Inc. have established a collaboration for developing and manufacturing high-potency, highly cytotoxic materials (e.g., small molecules, protein toxins, cytotoxic antibody drug conjugates, and other bioconjugates).
"Over the last 20 years, GBI has offered cell culture and purification process development, scale-up, GLP manufacturing and cGMP manufacturing services for cell culture-derived biopharmaceuticals as a contract manufacturing organization (CMO)," noted Muctarr Sesay , PhD, Vice President of Process Development at GBI.
Sesay continued, "For more than a decade, we have augmented these services by leveraging the bioconjugation experience and expertise of our staff to develop Antibody Drug Conjugates (ADCs), radioimmunoconjugates and other bioconjugates. 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 resultant products 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."
"Coldstream is also a CMO, tracing its origins to the University of Kentucky's Center for Pharmaceutical Sciences and Technology, and we offer small-volume, parenteral manufacturing services," said Eric W. Smart , President & CEO of Coldstream Laboratories.
Smart continued, "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."
GBI will collaborate with Coldstream to perform a number of activities within Coldstream's cGMP platform of services, including 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. Our GBI scientists will collaborate with Coldstream staff, to develop and manufacture products on behalf of our mutual clients," Dr. Sesay commented.
Mr. Smart added, "Our filling batch sizes will vary from tens of non-GMP vials for use in non-clinical, proof-of-concept studies to thousands of cGMP-compliant vials to enable human clinical trials and meet a wide spectrum of client needs."