Coldstream Laboratories, Inc., turns?pharmaceutical development?ideas into safe, pure, and effective pharmaceutical dosage forms. Since 2007, the company has delivered unique solutions to complex development and?manufacturing projects.
The Coldstream team is dedicated to delivering high quality products to satisfy international standards for both clinical and commercial applications. They are resolute in their commitment to provide quality pharmaceutical products to patients. The company’s regulatory history includes a successful FDA inspection and completion of numerous client audits.
Together with Goodwin Biotechnology, Inc. (GBI) the company develops and manufactures highly potent, cytotoxic biologics and bioconjucates (e.g., protein toxins, cytotoxic antibody drug conjugates, and other bioconjugates).
The area of potent bioconjugates has been growing for several years and due to the nature of the complexity of these molecules, the supply chain for developing these drugs can be quite challenging to manage. The Coldstream/Goodwin team is able to meet the needs of this industry. ?Together, the two companies bring their particular expertise to support the manufacture of these cytotoxic bioconjugates including analytical testing, formulation, and process development of liquid and lyophilized sterile highly-potent antibody-drug conjugates (ADCs).
1500 Bull Lea Road
Suite 250
Lexington, KY 40511
