Piramal Pharma Solutions Press Releases

Press Releases

Coldstream to Attend InformEx 2015

Posted on Tue, Jan 27, 2015 @ 12:03 PM by Kathy Sue Bennett in lyophilization, in parenteral manufacturing, in sterile manufacturing

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

Posted on Fri, Jan 23, 2015 @ 05:10 PM by Kathy Sue Bennett in lyophilization, in parenteral manufacturing, in parenteral development, in sterile manufacturing, in antibody drug conjugates

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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Coldstream Laboratories Partners with CytImmune for Phase II Sterile Manufacturing

Posted on Tue, Sep 16, 2014 @ 11:41 AM by Kathy Sue Bennett in lyophilization, in parenteral manufacturing, in sterile manufacturing

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 [email protected] 

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Coldstream Laboratories Names Director of Formulation Development

Posted on Mon, Nov 18, 2013 @ 10:56 AM by Kathy Sue Bennett in lyophilization, in parenteral manufacturing, in parenteral development, in sterile manufacturing, in product development

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

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Coldstream Laboratories to Attend Informex 2013

Posted on Fri, Feb 08, 2013 @ 10:47 AM by Kathy Sue Bennett in lyophilization, in lyophilized products, in parenteral manufacturing, in sterile manufacturing

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.

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Difficult-to-Lyophilize Products: A Brief Look at Lyophilization Development

Posted on Tue, Dec 18, 2012 @ 12:31 PM by Charles Reichel in lyophilization, in lyophilized products, in product development, in lyocycle optimization

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. 

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Coldstream Laboratories Upgrades Sterile Manufacturing Facility

Posted on Tue, Jul 24, 2012 @ 09:42 AM by Kathy Sue Bennett in lyophilization, in lyophilized products, in sterile manufacturing, in product development

(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.

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