Jan 01, 2022
RIA helped a Biotech company to develop a plan for immunogenicity assessment for new biologics licensing application (BLA) for Multiple Sclerosis treatment
Challenge
What are the BLAs approved for the treatment of MS?
What are the important elements of the immunogenicity assessment?
What are the important elements of the immunogenicity assessment?
What is the landscape of immunogenicity assessment across other approved BLAs for the treatment of MS?
Outcomes
Biologics applications approved for treatment of MS and important elements of immunogenicity assessment are quickly identified
The immunogenicity landscape across all BLAs and BLAs for MS are summarized
Immunogenicity assessment details across all 8 biologics and 10 applications was collated from the summary basis of approvals
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