Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

GBI and Coldstream Laboratories Announce a Collaboration

Published: Tuesday, May 07, 2013
Last Updated: Tuesday, May 07, 2013
Bookmark and Share
Collaboration to develop and manufacture cytotoxic Antibody Drug Conjugates.

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.

Sesay continued, "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.

Smart continued, "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."


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,300+ scientific posters on ePosters
  • More Than 4,900+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Goodwin Biotechnology and Aspyrian Therapeutics Collaborate
Collaboration on the successful GMP manufacturing and IND submission for a novel Antibody Drug Conjugate platform.
Friday, June 12, 2015
Goodwin Biotechnology was Selected by Panacea Pharmaceuticals
Selected for a highly specialized vaccine fill / finish project.
Thursday, May 28, 2015
Goodwin Biotechnology, Aspyrian Therapeutics Collaborate on Innovative Antibody Drug Conjugate
The agreement is for the technology transfer, process development, scale - up, and cGMP manufacturing of a novel Antibody Drug Conjugate (ADC) for use in Phase I clinical trials.
Tuesday, March 25, 2014
GBI and OncoMax Announce a Collaboration for an Important Advance in Oncology
Agreement for cell line engineering and manufacturing of a monoclonal antibody.
Monday, February 13, 2012
Goodwin Biotech, Rafagen In Cell Line Pact
Goodwin Biotechnology and Rafagen have entered a collaboration agreement for cell line engineering and biological contract manufacturing.
Friday, May 27, 2011
Scientific News
Shedding Light on HIV Vaccine Design
Broadly speaking - Mathematical modelling of host-pathogen coevolution sheds light on HIV vaccine design.
AACC 2016 Sees Clinical Chemistry Labs Drive Precision Medicine Offerings
Biomarker assays to enable precision medicine and risk assessment, mass spec-based tests designed for use in clinical labs large and small, and liquid biopsy technology captured the spotlight at the AACC annual meeting.
Automated Patch Clamping Trends
Learn more about current practices, preferences and metrics in ion channel drug screening using APC technology.
Emerging Model of Cancer
Cancer acts cooperatively, making individual decisions but acting in unison; this insight is being used to create a computer model of cancer.
Biological Barcodes Using CRISPR
Using genome editing tools, researchers are getting closer to understand differentiation of various cell types during development.
Controlling DNA Repair
Scientists discover that DNA repair outcomes following CRISPR-Cas9 cleaving are non-random and can be harnessed to produce desired effects.
Demonstrating LNP Delivery of CRISPR Components
Intellia has presented data demonstrating in vivo gene editing ising liquid nanoparticles (LNPs) to deliver CRISPR/Cas9.
Decades Old Chemicals Linked to Current Increased Autism Risk
The chemcials - organochlorines - were banned in the US in 1977 but their side effects are still being seen.
FINCH Filgotinib Phase 3 Program Initiated
Galapagos NV reports the initiation of the FINCH global Phase 3 program in rheumatoid arthritis patient populations.
Enzyme that Triggers Cell Demise in ALS Identified
Scientists from Harvard have identified a key instigator of nerve cell damage in people with amyotrophic lateral sclerosis (ALS).
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!