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.
We sat down with Forge regulatory team members Christopher Shilling, M.S., Senior Vice President of Regulatory Affairs, and Angela Coy, Ph.D., Senior Manager of Regulatory Affairs. They 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.
Watch the video to learn more.
What is included in Forge's DMF?
DMFs come in all shapes and sizes, but Forge's DMF includes the following components:
How does Forge's DMF improve timelines?
Our DMF can tremendously improve timelines and resources for programs that are entering the clinic. Forge ensures that the DMF has helped to de-risk any client's IND application and can save them months around the submission of an IND. In addition, clients can spend less time or resources to rewrite CMC information from a small library of manufacturing documents and records. There's no need to reinvent the wheel. We've already authored and vetted the documentation through the FDA.
What differentiates Forge from other CDMOs?
Forge is unique because we have our pipeline program. As such, we are securing the necessary FDA approvals for our manufacturing process and facility long before our clients need them. Clients can also have confidence that the DMF has been reviewed and the CMC information has been adopted under a prior program – our internal pipeline program.
What are the main components of an IND?
How can gene therapy developers set themselves up for better FDA review outcomes?
Here are some tips for setting up for success with the FDA:
What are other ways Forge provides regulatory support?
Click here to learn more about Forge's regulatory support and speak with our AAV experts.