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Last updated on April 23, 2014 at 13:36 EDT

Goodwin Biotechnology Announces Process Development Sub-Contract for an Anthrax Vaccine

June 3, 2013

PLANTATION, Fla., June 3, 2013 /PRNewswire/ — Goodwin Biotechnology, Inc. (GBI) announced today the award of a sub-contract from Emergent BioSolutions for GBI to conduct some early stage proof-of-concept feasibility process development to investigate concentrating AVA filtrate for storage before the downstream process for BioThrax(®) (Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration for the protection against anthrax disease. Anthrax is a potentially deadly disease that is caused by the bacteria Bacillus anthracis. While Anthrax does not spread directly from one infected animal or person to another, it is spread by endospores that are able to survive in harsh conditions for long periods of time, and those spores can lie dormant for years and possibly decades. When the spores are inhaled, ingested, or come into contact with a skin lesion on a host, they may germinate and multiply rapidly in both humans and animals.

“We’re excited about the opportunity to contribute our protein purification as well as processing experience and expertise which have been developed and refined over the last 20 years,” noted Muctarr Sesay, PhD, Vice President of Process Development at GBI. “Our goal is to develop process parameters that are amenable to routine GMP production and large-scale manufacturing in an effort to contribute to the production of BioThrax at large scale.”

Heidi Nielsen, Process Development Engineer for the Biodefense Division of Emergent BioSolutions said, “This phase of process development is critical to our project. We chose to work with Goodwin Biotechnology based on their Quality Systems and experience with large scale, GMP-compliant protein purification and processing.”

About Goodwin Biotechnology, Inc.
Goodwin Biotechnology is a world-class CMO that offers a Single Source Solution(TM) through partnerships with clients for cell line development or exploratory proof of concept projects through process development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines and Antibody Drug Conjugates (ADCs) for early and late stage clinical trials. 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 multi-national biopharmaceutical companies. Additional information may be found at www.GoodwinBio.com.

For more information on the process development and GMP manufacturing of biologics, please contact Goodwin Biotechnology:
Robin McCallum
Business Development Manager
(954) 327-9656
RMcCallum@GoodwinBio.com

SOURCE Goodwin Biotechnology, Inc.


Source: PR Newswire