LEXINGTON, KY--(Marketwired - Sep 24, 2013) - Coldstream Laboratories, Inc., a provider of sterile drug product development and manufacturing services, has announced that they have been awarded a 5-year contract with the National Cancer Institute ("NCI") under solicitation number N02CM37007-11 (contract# HHSN261201300031I) entitled "Development and Production of Parenteral Dosage Forms for Clinical Studies."
Christopher A. Verbicky, Ph.D., MBA, will be attending the “6th Product and Pipeline Enhancement for Generics Conference” in this week in Washington, D.C. The event will take place at the Sheraton Crystal City Hotel July 23 – 25, 2013.
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).
Photo Caption: Equinext’s President and CEO, Eric Hauck, with Eric Smart, President and CEO of Coldstream Laboratories in Coldstream’s sterile manufacturing facility.
Representatives from Coldstream Laboratories will be attending Informex 2013 in Anaheim, CA. The event will take place at the Anaheim Convention Center February 19 - 22, 2013.
LEXINGTON, KY (Marketwire - October 29, 2012) – Eric W. Smart has been named the new President and CEO of Coldstream Laboratories Inc., the largest sterile pharmaceutical manufacturing facility in Kentucky.
The sterile manufacturing facility at Coldstream Laboratories employs unique mobile isolator technology to allow flexibility in executing a wide variety of manufacturing processes. Our isolators facilitate handling of difficult-to-manufacture drug products and ensure the safety of our workforce throughout the production process. Mobile isolators provide an ISO Class 5 environment for aseptic processing and minimize human contact with the products we manufacture. This technology allows Coldstream to process a variety of potent drug substances such as cytotoxins in an adaptable alternative manufacturing setting when compared to standard clean rooms.
Pharmaceutical grade water is the most commonly used ingredient in sterile pharmaceutical manufacturing and acceptable water purity is critical to producing quality final drug product. Water for Injection (WFI) is water that is purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms. Pharmaceutical manufacturers are moving from laboratory to on-line analysis for real time water release. Real-time release can greatly improve efficiencies and cost while allowing for increased quality assurance awareness. Real-time release of pharmaceutical waters increases system understanding, decreases QC testing, reduces batch risk and improves process controls.
(Lexington, KY—(Marketwire—July 24, 2012) - Coldstream Laboratories, Inc., a Lexington, Kentucky, based pharmaceutical and biotechnology development and manufacturing firm announced today the initiation of significant enhancements to its manufacturing facility. Work began last week on expanding a number of key systems in the sterile drug product manufacturing plant aimed at improving efficiencies and expanding capacity to produce parenteral products.