posted on April 30, 2009 16:15
LEXINGTON, Ky. (May 1, 2009) – On Thursday May 1, 2009 Coldstream Laboratories Inc., celebrated two years of business. The parenteral formulation development and manufacturing company achieved a number of important milestones in its first two years of operations. Among these achievements were:
· Commissioned a state-of-the-art sterile manufacturing facility based on isolator technology
· Manufactured over a dozen different sterile products during the first full year of manufacturing operations. Projects included pre-clinical through Phase III clinical trial materials as well as registration materials for a commercial product
· Prepared registration materials for its first commercial product to be manufactured on behalf of a client
· Completed its first FDA inspection in its sterile manufacturing facility
· Installed an automated filling line for topical products
· Doubled the size of its technical staff to support formulation, analytical and microbiological methods development
“We are very proud of our first two years of operations. Our staff has grown in terms of both size and experience and it has been gratifying to see the company develop since our spin-off from the University of Kentucky’s College of Pharmacy,” said Dr. Joseph Wyse President and CEO of Coldstream Laboratories, Inc.
“ Our future looks bright.”, said Wyse. “Customers appreciate our work ethic and enthusiasm for helping them meet their goals in clinical trials and generic drug filings. As a result, we are already seeing repeat work from a number of our customers.”
Coldstream Laboratories Inc. is Kentucky’s only sterile pharmaceutical manufacturing facility featuring isolator technology. Facilities are located at the University of Kentucky’s Coldstream Research Campus in Lexington, KY. Coldstream Laboratories operates a 20,000 sqft manufacturing plant and employs 60 full time employees.