通过扩展，支持比原计划大 8 倍的 BLA
A commercial stage biopharmaceutical company focused on the development of novel treatments for B-cell diseases was focused on pursuing FDA approval for a recombinant IgG1 chimeric monoclonal antibody, for the treatment of relapsing forms of multiple sclerosis (MS). In 2021, they called upon Certara Synchrogenix to support their BLA submission, which came on the heels of another BLA we submitted for them in March 2021. Work on the BLA began in April 2021. Initially, the BLA was expected to be about 500,000 pages. However, the page count grew exponentially following the FDA’s insistence that more Case Report Forms (CRFs) be included in the application.
The Certara Synchrogenix team resourced thirty team members throughout Certara’s global locations to meet the challenge of completing publishing for an application that had grown to 8x larger than originally planned.