ries. "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 a
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