Coldstream Laboratories Blog

Coldstream to Attend Bio International Convention 2015

Posted by Jason Dwinell on Fri, Jun 12, 2015 @ 05:04 PM

Coldstream Laboratories, Inc., a Piramal Enterprises business, will be attending Bio Internatinal Convention 2015 in Philadelphia, PA. The event will take place at the Pennsylvania Convention Center June 15-18, 2015.

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Tags: lyophilized products, aseptic filling, antibody drug conjugates

Coldstream to Attend InformEx 2015

Posted by Kathy Sue Bennett on Tue, Jan 27, 2015 @ 12:03 PM

A representative from Coldstream Laboratories, a Piramal Enterprises business, will be attending InformEx 2015 in New Orleans, LA. The event will take place at the Morial Convention Center February 3 - 5, 2015.

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Tags: lyophilization, parenteral manufacturing, sterile manufacturing

Piramal Enterprises acquires Kentucky based Specialty Pharmaceutical CDMO, Coldstream Laboratories Inc.

Posted by Kathy Sue Bennett on Fri, Jan 23, 2015 @ 05:10 PM

Mumbai, 16th January, 2015: Piramal Enterprises Limited (‘PEL’, NSE: PEL, BSE: 500302) today announced that it has invested USD 30.65 million towards acquiring Coldstream Laboratories Inc. (‘Coldstream’), through its wholly owned subsidiary in the USA in an all cash transaction.  Of this, USD 5.65 million would be towards the purchase of the facility building which is currently leased to Coldstream, while the rest would be towards purchase of 100% of the company’s shares. Coldstream is a Contract Development and Manufacturing Organisation (CDMO) focused on the development and manufacturing of sterile injectable products.

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Tags: lyophilization, parenteral manufacturing, parenteral development, sterile manufacturing, antibody drug conjugates

Coldstream Laboratories Partners with CytImmune for Phase II Sterile Manufacturing

Posted by Kathy Sue Bennett on Tue, Sep 16, 2014 @ 11:41 AM
LEXINGTON, Ky., Sept. 16, 2014 (GLOBE NEWSWIRE) --Coldstream Laboratories, Inc. a provider of sterile drug product development and manufacturing services, has announced a partnership with CytImmune to manufacture CYT-6091 for injection in preparation for Phase II clinical trials.  CYT-6091 is part of CytImmune's Aurimune platform.  Specifically, Coldstream shall perform scale-up and optimization of the manufacturing and lyophilization process to enable the manufacture of clinical trial materials.

CYT-6091 is comprised of gold nanoparticles bound with an immune-avoiding component (PEG-Thiol) and tumor necrosis factor alpha (TNF) which has been successfully tested at the National Cancer Institute, Bethesda, Maryland, in a Phase I clinical trial in advanced-stage cancer patients. As seen in that study, the gold nanoparticles were observed to accumulate in tumor tissues while leaving healthy tissue unaffected. The Aurimune platform provides a significantly enhanced safety profile for TNF when formulated as CYT-6091 compared to systemically administered TNF.

The Phase II trials, to be conducted in New York City at Montefiore Einstein Center for Cancer Care will scale production tenfold from Phase I manufacturing. The study will be designed to test how well CYT-6091 benefits lung cancer patients.

Dr. Lawrence Tamarkin, CytImmune’s CEO said, “We have seen proven success of CYT-6091 in Phase I clinical trials. We are looking forward to partnering with Coldstream in preparation for Phase II trials in an effort to move cancer care forward.”

Coldstream’s President & CEO, Eric W. Smart, added, “We are extremely pleased that CytImmune has chosen Coldstream as their CMO. We are confident that the encouraging results from CYT-6091 trials paired with Coldstream’s parenteral manufacturing expertise will lead to a successful relationship and improve treatments available to cancer patients.”
 
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About CytImmune
CytImmune is a clinical stage nanomedicine company with a core focus on the discovery, development and commercialization of multifunctional, tumor-targeted cancer therapies. Based on a research and development strategy to harness the unique properties of gold nanoparticles, cytotoxic agents, and biology of tumors, CytImmune is developing a pipeline of proprietary drug candidates by binding potent anti-cancer agents – whose toxicity profiles currently prevent or severely limit clinical use – to its patented tumor-targeting platform nanotechnology. The company's nanomedicine technology is highly versatile and may be used with a broad spectrum of anti-cancer agents. For more information on CytImmune, please visit www.cytimmune.com.

About Coldstream Laboratories
Coldstream Laboratories, Inc., based in Lexington, KY, is a privately held specialty pharmaceutical contract manufacturing organization, also offering full analytical, formulation, microbiology and lyophilization development services. Coldstream specializes in the development and manufacture of highly potent compounds and operates Kentucky’s only parenteral manufacturing facility. For more information, visit www.coldstreamlabs.com or email customerservice@coldstreamlabs.com 
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Tags: lyophilization, parenteral manufacturing, sterile manufacturing

Coldstream Expands Business Development Group

Posted by Kathy Sue Bennett on Wed, Jun 11, 2014 @ 11:38 AM

LEXINGTON, KY--Coldstream Laboratories, Inc., a provider of parenteral manufacturing and sterile drug product development services, announced that Jason Dwinell has joined the Business Development Group in the role of Business Development Manager.  In this position, Mr. Dwinell will primarily represent the territory west of the Rocky Mountains.

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Tags: parenteral manufacturing, sterile manufacturing

Coldstream Laboratories Completes Successful FDA Inspection

Posted by Kathy Sue Bennett on Tue, Apr 22, 2014 @ 09:31 AM

LEXINGTON, KY., Apr 21, 2014 (GLOBE NEWSWIRE) --Coldstream Laboratories, Inc., a provider of sterile drug product development and manufacturing services, has announced the completion of a successful inspection by the Food and Drug Administration (FDA). Coldstream hosted FDA authorities from April 8 – 17, 2014, at its manufacturing facility in Lexington, KY. The site audit reviewed quality systems to ensure compliance with current Good Manufacturing Practices (cGMPs).  

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Tags: parenteral manufacturing, parenteral development, sterile manufacturing

Coldstream Laboratories Third-Time Winner of CMO Leadership Award

Posted by Kathy Sue Bennett on Fri, Apr 11, 2014 @ 09:37 AM
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Tags: parenteral manufacturing, parenteral development, sterile manufacturing

Coldstream Announces Key Quality Certifications for Team Members

Posted by Kathy Sue Bennett on Wed, Feb 05, 2014 @ 03:15 PM

LEXINGTON, KY--(Marketwired – February 5, 2014) - Coldstream Laboratories, Inc., a provider of sterile drug product development and manufacturing services, has announced certifications for four key members of its Quality Assurance Team.

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Tags: parenteral manufacturing, sterile manufacturing, pharmaceutical development

Coldstream Laboratories Names Director of Formulation Development

Posted by Kathy Sue Bennett on Mon, Nov 18, 2013 @ 10:56 AM

Adrian Raiche, Ph.D. Named as Director of Formulation Development at Coldstream Laboratories, Inc.

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Tags: lyophilization, parenteral manufacturing, parenteral development, sterile manufacturing, product development

Coldstream to Exhibit at World ADC Conference

Posted by Kathy Sue Bennett on Thu, Oct 10, 2013 @ 09:40 AM

Coldstream and Goodwin Biotechnology will co-exhibit at the World ADC Summit in San Francisco, CA, from October 14th to 17th.  Please meet us at Booth #13 to discuss your cytotoxic antibody drug conjugation needs.

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Tags: parenteral manufacturing, sterile manufacturing, aseptic filling, antibody drug conjugates