Cleveland BioLabs [CBLI] has completed the technology transfer to its manufacturing partner for Protectan CBLB502, which the company has developed for medical radiation countermeasures to treat gastrointestinal effects of acute radiation syndrome. Production of the first Good Manufacturing Practices compliant batch of Protectan was also completed ahead of schedule. Cleveland BioLabs submitted Protectan in response to a Defense Department Request for Proposals. A contract would provide funding for development of the countermeasure through approval by the Food and Drug Administration, as well as a commitment to purchase up to 500,000 doses. “We were able to develop a complicated, high-yield manufacturing process for CBLB502 due to the excellent work of our subcontractors at SynCo Bio Partners and our in-house team, which was able to prototype the process and resolve multiple challenges during industrial development together with our consultants,” says Dr. Michael Fonstein, president and CEO of Cleveland BioLabs.
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