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 Technimates Professionals, 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.