Goodwin has been subcontracted through to the third quarter this year to support Emergent’s vaccine BioThrax, the only vaccine licensed by the US Food and Drug Administration for pre-exposure protection against anthrax.
Speaking with Outsourcing-pharma.com, Goodwin spokesman David Cunningham said the CMO would be “performing exploratory proof-of-concept development of linearly scalable and GMP compliant downstream processes for longer term storage of a vaccine intermediate for future downstream processing as needed.”
Though for now the deal will only involve downstream process development services, Cunningham said “when needed, additional work will be covered under additional subcontracts” between the companies.
According to Heidi Nielsen, Process Development Engineer for the Biodefense Division of Emergent, “this phase of process development is critical to our project” and Goodwin was selected “based on their Quality Systems and experience with large scale, GMP-compliant protein purification and processing.”
Goodwin has developed numerous equivalent downstream processes and, said Cunningham, will be leveraging twenty years of protein processing experience in this subcontract.
Recently Goodwin teamed up with Coldstream Laboratories to develop antibody-drug conjugates (ADCs) in response to the high demand in the biopharmaceutical sector for contract manufacturing services.
Emergent was awarded a contract worth $107m in 2010 from the Office of the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services (HHS) in order to build up a strategic stockpile of BioThrax, in the case of a bioterror attack.
Caused by the bacteria Bacillus anthracis, anthrax is a potentially deadly disease considered likely to be used in biological warfare due to its ability to infect via respiratory routes.
The HHS contract coincided with the addition of 55,000 sq ft of extra at Emergent’s Baltimore, Maryland plant and upped capacity from 8m to 26m doses of BioThrax a year.
This came two years after the opening of a 50,000 sq ft facility in Michigan dedicated to BioThrax production caused partially by a 2007 deal from the US Government worth $120m to deliver 5m doses