Coldstream Laboratories Blog

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.

In order to effectively develop a lyophilization cycle, it is important to understand the glass transition temperature (through Differential Scanning Calorimetry “DSC”) and collapse temperature (through Freeze-Drying Microscopy “FDM”) of the formulation between the liquid, glassy, and frozen states.  These values will help define the maximum product temperature that the product can achieve during primary drying in order to prevent collapse or melt back of the product due to incomplete sublimation of unbound moisture and/or solvent.  This should happen prior to the ramp to secondary drying with final removal of the bound moisture and/or solvent. 

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.

In April of 2012, Coldstream Laboratories expanded its sales presence to the West Coast with the addition of Heidi Kipers as Business Development Manager.  As Coldstream’s West Coast sales representative, Heidi is based in San Diego, CA, and represents the territory west of the Rocky Mountains. 

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.

Coldstream Labs is excited to announce a successful showing at the BIO International Conference 2012 that took place in Boston, MA, June 18-21, 2012. 

Eric Smart, Executive Vice President; Chris Verbicky, Director of Business Development and Marketing; Heidi Kipers, Business Development Manager; and Kathy Sue Bennett, Marketing Manager; represented Coldstream at the four-day event at the Boston Convention Center.

       Photos from the event which featured Kentucky bourbons, hot browns, Derby pies, and pulled pork biscuits.

Highlights of the show included a Kentucky Derby-themed bourbon tasting where potential clients could sample four premium Kentucky bourbons and have a taste of Kentucky hors d’oeuvres while learning about Coldstream’s parenteral manufacturing services.  Approximately 300 people attended the exhibit hall reception, held on Tuesday evening of the exhibition.  It proved to be a fun and unique way to publicize Coldstream.  Coldstream hopes to host similar receptions at future tradeshows and conferences.