Plantation, Florida and Lexington, Kentucky-- 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. “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. “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.”
About Coldstream Laboratories, Inc.
Coldstream Laboratories is a specialty manufacturer of sterile injectable drugs and operates a state-of-the-art parenteral manufacturing facility in Lexington, KY. We specialize in the development and manufacture of highly toxic compounds that are safe and effective drug products by employing state-of-the-art mobile isolator technology in our sterile manufacturing facility to provide a physical barrier that protects our staff from toxic substances and encloses your product in an ISO Class 5 Environment. Similar isolators are used in our development labs to mimic manufacturing operations and enable formulation and analytical development on toxic substances. Through the use of these high containment isolators, our scientists create and maintain a controlled sterile envelope that enables us to safely process potent drug classes including cytotoxic antibody drug conjugates, cytotoxins, steroids, hormones and acutely toxic substances. Coldstream’s scope of services ranges from proof-of-concept through to commercial manufacturing.
About Goodwin Biotechnology, Inc.
Goodwin Biotechnology is a world-class CMO that offers fully integrated, development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines and Antibody Drug Conjugates (ADCs). By working with GBI, our clients can enhance the value of their product candidates with clear development and manufacturing strategies as well as a road map to meet the highest quality product requirements from the milligram and gram range to kilogram quantities as the product candidates move along the clinical approval pathway in a cost-effective, timely and cGMP compliant manner to enhance patients’ lives. With over 20 years of experience as an independent contract manufacturer, GBI has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multinational biopharmaceutical companies.
For more information on antibody drug conjugation and other bioconjugation projects, please contact Goodwin Biotechnology:
Business Development Manager
For more information on high containment, as well as lyophilization and Fill & Finish capabilities, please contact Coldstream Laboratories:
Christopher Verbicky, PhD, MBA
Director Business Development & Marketing