BBiologics & BLA
Biologics are genetically-engineered proteins derived from human genes. They are designed to inhibit specific components of the immune system that play pivotal roles in fueling inflammation, which is a central feature of rheumatoid arthritis. BLA’s (Biologics License Application) is a request for permission to introduce Biologics to Interstate Commerce. Biologics are manufactured in extremely Sterile Environments.
At RevereIT LLC, we
- Develop and execute validation protocols for manufacturing equipment’s, utilities and methods used at all levels of Biologics manufacturing.
- Perform late stage development, qualification and validation of Biologics production methods.
- Analyze test results, draft validation/engineering reports and make technical recommendations.
- Provide technical input with respect to validation requirements.
- Qualify Facility, Clean Room, Packaging Systems, HVAC, Filling Lines for Biologics as per FDA standards.