What The DMF! Spotlight On Forge's Drug Master File

Gene therapy developers' Investigational New Drug (IND) application process is arduous and critical in delivering safe and effective patient therapies. A key benefit of partnering with a contract development and manufacturing organization (CDMO) like Forge, which offers a full suite of regulatory services, is that we maintain a Drug Master File (DMF) with the Food & Drug Administration (FDA). In addition, Forge provides platform Chemistry Manufacturing and Controls (CMC) documentation that can augment an entire section of a program's IND application and save months in the process of regulatory filing.

Forge regulatory team members Christopher Shilling, M.S., Senior Vice President of Regulatory Affairs, and Angela Coy, Ph.D., Senior Manager of Regulatory Affairs, highlighted the critical elements of Forge's DMF, shared some tips for engaging with the FDA, and demonstrated how our DMF could serve as a regulatory CMC platform with the ability to adapt to our clients' needs for bespoke outcomes.