New drug development and manufacturing for clinical trials play a critical role in the advancement of new medical treatments. MassBiologics has a long history of biologics development to address unmet medical needs. MassBiologics' experience with FDA licensed vaccines and immunoglobulins, coupled with its innovation in the development of new biologic molecules provide an infrastructure to move products forward.
MassBiologics is able to assist collaborators or clients by providing a variety of Development, Analytical and Manufacturing services. Our process development experience is broad having manufactured multiple IND products for clinical studies. Our manufacturing teams are experienced in both bacterial and mammalian cell based expression systems and have downstream processing capability for the production of bulk drug substance at the kg scale. MassBiologics' aseptic fill finish operations are state of the art and capable of filling from small to large scale, addressing the needs of clients with small clinical bulks minimizing product loss as well as commercial clients whose fills benefit from using our high speed Bosch filling line.
As an FDA licensed biologics manufacturer, MassBiologics maintains both investigational and commercial programs supported by strong cGMP systems for Facility Operations, Quality Assurance, Quality Control, Supply Chain and Regulatory Affairs. Our project managers have proven experience in leading technology transfers and the manufacture of human monoclonal antibody products both in the US and internationally.