KLH is an immune-stimulating protein used in a range of therapeutic and diagnostic markets, according to the company.
The proprietary information on the manufacturing and safety of a drug component is included in the biologics master file.
Stellar Biotechnologies chief pharmaceutical officer Catherine Brisson said, "We are very pleased to have this master file submitted to CBER. By ensuring that the information required by FDA is accessible, we can facilitate regulatory approvals for KLH-based products."
Stellar expects to support its KLH customers filing applications under the CBER division in addition to extending KLH applicability through the new BB-MF.