Coldstream Laboratories Blog

Coldstream Laboratories Blog

Piramal Healthcare Invests £2.0 mn in Scotland

Posted on Thu, Feb 11, 2016 @ 08:47 AM by Piramal Pharma Solutions in antibody drug conjugates

17th November 2015: Piramal Healthcare UK Ltd., has invested £2.0 million into Scotland to expand its manufacturing base at Grangemouth, to manufacture Antibody Drug Conjugates to global markets. This new investment into Scotland will yield additional revenue of £3-5 mn over 5 years to Piramal Healthcare’s revenues.

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Piramal Pharma Solutions receives ‘API Supplier of the Year’ award at Global Generics and Biosimilar Award 2015

Posted on Thu, Feb 11, 2016 @ 08:43 AM by Piramal Pharma Solutions in pharmaceutical development

21st October, 2015: Piramal Pharma Solutions (PPS), a division of Piramal Enterprises Limited, is pleased to announce that it is the recipient of the ‘API Supplier of the Year’ award for 2015 at Global Generics and Biosimilar Award. This prestigious award, sponsored by Honeywell, Thomson Reuters, Panacea, Pharmawise, Pharmacloud, and Ark Patents, recognizes best business practices, and operational & R&D achievements in Global Generics and Biosimilars.

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Piramal Pharma Solutions, CEO Vivek Sharma receives ‘CEO of the Year’ award at CPhI Awards 2015

Posted on Thu, Feb 11, 2016 @ 08:39 AM by Piramal Pharma Solutions

20th October, 2015: Piramal Enterprises' Pharma Solutions division, a global leader in contract development and manufacturing (CDMO), each year participates at the CPhI Worldwide. This is a convention that brings together the global pharmaceutical community to meet and identify business opportunities.

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Piramal expects global sterile sales growing at 10% annually for the next 5 years

Posted on Thu, Feb 11, 2016 @ 08:30 AM by Piramal Pharma Solutions in sterile manufacturing

14th October, 2015: Piramal Enterprises' Pharma Solutions division, a global leader in contract development and manufacturing (CDMO), has delivered its comprehensive review of the injectables market – both sterile and small molecule – for the next 5 years during its CPhI annual report piece.

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Coldstream to Attend Bio International Convention 2015

Posted on Fri, Jun 12, 2015 @ 05:04 PM by Jason Dwinell in lyophilized products, in aseptic filling, in antibody drug conjugates

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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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 customerservice@coldstreamlabs.com 

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Coldstream Expands Business Development Group

Posted on Wed, Jun 11, 2014 @ 11:38 AM by Kathy Sue Bennett in parenteral manufacturing, in sterile manufacturing

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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Coldstream Laboratories Completes Successful FDA Inspection

Posted on Tue, Apr 22, 2014 @ 09:31 AM by Kathy Sue Bennett in parenteral manufacturing, in parenteral development, in sterile manufacturing

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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