Corporate Banner
Satellite Banner
Immunology
Scientific Community
 
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 3,000+ scientific posters on ePosters
  • More than 4,500+ 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

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
Scientific News
AACR 2016: Cancer Immunotherapy and Beyond
At this year's meeting there was a palpable buzz around subjects ranging from microbiomics to the tumor microenvironment and cancer vaccines, big data to in vitro and in vivo modeling and drug delivery (to name just a few).
Intestinal Worms Boost Immune System In A Surprising Way
EPFL researchers find that intestinal worm infections cause lymph nodes to produce more immune cells as well as grow in size.
Breast Milk Hormones Impact Bacteria In Infants’ Guts
Intestinal microbiome of children born to obese mothers significantly different from those born to mothers of healthy weight, CU Anschutz researchers find.
Improving Natural Killer Cancer Therapy
Vanderbilt University researchers discover transcription factor critical for NK cell expansion. Findings could lead to increased therapeutic efficacy.
Molecular Mechanism For Generating Specific Antibody Responses Discovered
Study could spur more ways to treat autoimmune disease, develop accurate vaccines.
Gut Microbiomes Of Infants Have An Impact On Autoimmunity
Exposure to pathogens early in life is beneficial to the education and development of the human immune system.
Understanding Female HIV Transmission
Glowing virus maps points of entry through entire female reproductive tract for first time.
COPD Linked to Increased Bacterial Invasion
Persistent inflammation in COPD may result from a defect in the immune system that allows airway bacteria to invade deeper into the lung.
Finding Factors That Protect Against Flu
A clinical trial examining the body’s response to seasonal flu suggests new approaches for evaluating the effectiveness of seasonal flu vaccines.
Vaccinations Are More Effective When Administered In The Morning
Research from the University of Birmingham shows that influenza vaccinations have more protective responses when administered in the morning.
SELECTBIO

SELECTBIO Market Reports
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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!