Goodwin Biotechnology, Inc. this week announced award of a sub-contract from Emergent BioSolutions to conduct early stage proof-of-concept feasibility process development to investigate concentrating AVA filtrate for storage before the downstream process for Emergent’s BioThrax (Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration for the protection against anthrax disease.
“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 Goodwin. “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.
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.
“This phase of process development is critical to our project,” said Heidi Nielsen, Process Development Engineer for the Biodefense Division of Emergent BioSolutions. “We chose to work with Goodwin Biotechnology based on their Quality Systems and experience with large scale, GMP-compliant protein purification and processing.”
Source: Goodwin Biotechnology