Navigation Links
Goodwin Biotechnology and Coldstream Laboratories Announce a Collaboration to Develop and Manufacture Cytotoxic Antibody Drug Conjugates

PLANTATION, Fla. and LEXINGTON, Ky., April 25, 2013 /PRNewswire/ -- 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).

"Over the last 20 years, GBI has offered cell culture and purification process development, scale-up, GLP manufacturing and cGMP manufacturing services for cell culture-derived biopharmaceuticals as a contract manufacturing organization (CMO)," noted Muctarr Sesay , PhD, Vice President of Process Development at GBI. "For more than a decade, we have augmented these services by leveraging the bioconjugation experience and expertise of our staff to develop Antibody Drug Conjugates (ADCs), radioimmunoconjugates and other bioconjugates. To address growing market demands for ADCs employing highly potent and cytotoxic therapeutic payloads, it has recently become clear that a collaboration is needed with a company that has high-containment and isolation capabilities relative to the handling, processing, characterization, fill and finish, lyophilization, and storage of these cytotoxic materials.  The resultant products are designed to provide highly specific targeting of cancer cells, for example, and enhanced cell killing ability. The result will be improved therapeutic effectiveness with minimal toxicity when compared to traditional therapeutic approaches."

"Coldstream is also a CMO, tracing its origins to the University of Kentucky's Center for Pharmaceutical Sciences and Technology, and we offer small-volume, parenteral manufacturing services," said Eric W. Smart , President & CEO of Coldstream Laboratories. "Our FDA-inspected facility uses mobile-isolator technology to provide an ISO Class 5 environment affording high containment capacity that is well suited for manufacturing potent, cytotoxic products. Our skilled team of experts uses this highly sophisticated facility to safely and efficiently manufacture sterile, potent, drug products. This capability, coupled with the bioconjugation expertise of GBI, will help advance patient care through the delivery of sophisticated potent therapies."

GBI will collaborate with Coldstream to perform a number of activities within Coldstream's cGMP platform of services, including analytical testing, formulation, liquid or lyophilized fill and finish, storage and shipment of manufactured highly-potent bioconjugates. "These manufacturing activities may be performed for non-GMP proof-of-concept and process development work, as well as manufacturing to support both GLP Tox and cGMP. Our GBI scientists will collaborate with Coldstream staff, to develop and manufacture products on behalf of our mutual clients," Dr. Sesay commented. Mr. Smart added, "Our filling batch sizes will vary from tens of non-GMP vials for use in non-clinical, proof-of-concept studies to thousands of cGMP-compliant vials to enable human clinical trials and meet a wide spectrum of client needs."

About Coldstream Laboratories, Inc.
Coldstream Laboratories is a specialty manufacturer of sterile injectable drugs and operates a state-of-the-art parenteral manufacturing facility in Lexington, KY. We specialize in the development and manufacture of highly toxic compounds that are safe and effective drug products by employing state-of-the-art mobile isolator technology in our sterile manufacturing facility to provide a physical barrier that protects our staff from toxic substances and encloses your product in an ISO Class 5 Environment. Similar isolators are used in our development labs to mimic manufacturing operations and enable formulation and analytical development on toxic substances. Through the use of these high containment isolators, our scientists create and maintain a controlled sterile envelope that enables us to safely process potent drug classes including cytotoxic antibody drug conjugates, cytotoxins, steroids, hormones and acutely toxic substances. Coldstream's scope of services ranges from proof-of-concept through to commercial manufacturing.

About Goodwin Biotechnology, Inc.
Goodwin Biotechnology is a world-class CMO that offers fully integrated, development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines and Antibody Drug Conjugates (ADCs). By working with GBI, our clients can enhance the value of their product candidates with clear development and manufacturing strategies as well as a road map to meet the highest quality product requirements from the milligram and gram range to kilogram quantities as the product candidates move along the clinical approval pathway in a cost-effective, timely and cGMP compliant manner to enhance patients' lives. With over 20 years of experience as an independent contract manufacturer, GBI has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multinational biopharmaceutical companies.

For more information on antibody drug conjugation and other bioconjugation projects, please contact Goodwin Biotechnology:
Robin McCallum
Business Development Manager
(954) 327-9656

For more information on high containment, as well as lyophilization and Fill & Finish capabilities, please contact Coldstream Laboratories:
Christopher Verbicky , PhD, MBA
Director Business Development & Marketing

SOURCE Goodwin Biotechnology, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Lixte Biotechnology Announces Initiation Of A Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100
2. Cytos Biotechnology Ltd Reports First Quarter 2013 Financial Results and Recent Development
3. Plandai Biotechnology, Inc. Announces Shipment Of First Machinery To South African Production Facility
4. PharmaLeaders: Innovative Mid-Cap Biotechnology Benchmark Report - Financial Benchmarking, Pipeline Assessment & Competitive Analysis of Innovative Biotechs
5. Choose New Jersey and Partners to Promote New Jersey As Global Life Science Hub at Worlds Largest Biotechnology Event
6. Plandai Biotechnology, Inc. Enters Into License Agreement With Phyto Nutricare To Develop Nutraceutical Products
7. Biotechnology Market (Biopharmacy, Bioservices, Bioagri, Bioindustrial) Is Expected to Reach USD 414.5 Billion Globally in 2017: Transparency Market Research
8. NanoSight, One of the UKs Fastest Growing Biotechnology Companies, Wins a 2013 Queens Award for Enterprise - Innovation
9. Global Biotechnology Industry Market Research Report Now Available from IBISWorld
10. Plandai Biotechnology, Inc. Updates Progress Of Preparing Products For Market
11. San Diego State University Hosts Open House for Life Science Immersion Biotechnology Program
Post Your Comments:
(Date:11/24/2015)... Halozyme Therapeutics, Inc. (NASDAQ: HALO ) will be ... York on Wednesday, December 2 at 9:30 a.m. ET/6:30 ... CEO, will provide a corporate overview. th Annual ... 1:00 p.m. ET/10:00 a.m. PT . Jim Mazzola , ... corporate overview. --> th Annual Oppenheimer Healthcare Conference ...
(Date:11/24/2015)... 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: ... behalf of the Toronto Stock Exchange, confirms that as ... no corporate developments that would cause the recent movements ... --> About Aeterna Zentaris Inc. ... --> Aeterna Zentaris is a specialty biopharmaceutical company ...
(Date:11/24/2015)... ... November 24, 2015 , ... The Academy of Model Aeronautics (AMA), led by ... known as Multirotor Grand Prix, to represent the First–Person View (FPV) racing community. , ... have embraced this type of racing and several new model aviation pilots have joined ...
(Date:11/24/2015)... 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: ... the remaining 11,000 post-share consolidation (or 1,100,000 pre-share ... "Series B Warrants") subject to the previously disclosed ... 23, 2015, which will result in the issuance ... to the issuance of such shares, there will ...
Breaking Biology Technology:
(Date:11/17/2015)... -- Vigilant Solutions announces today that Mr. Dick W. ... --> --> Mr. Boyce ... at TPG Capital, one of the largest global investment ... revenue.  He founded and led TPG,s Operating Group, which ... 1997 to 2013.  In his first role, he served ...
(Date:11/12/2015)... , Nov. 12, 2015  A golden retriever that ... muscular dystrophy (DMD) has provided a new lead for ... Hospital, the Broad Institute of MIT and Harvard and ... . Cell, pinpoints a ... "escape" the disease,s effects. The Boston Children,s lab of ...
(Date:11/11/2015)... --  MedNet Solutions , an innovative SaaS-based eClinical technology company ... to announce that it will be a Sponsor of the ... be held November 17-19 in Hamburg , ... iMedNet , MedNet,s easy-to-use, proven and affordable ... been able to deliver time and cost savings of up ...
Breaking Biology News(10 mins):