For gene therapies, the road from bench to bedside can be long and complicated, including regulatory milestones that can be time- and resource-intensive. Communicating chemistry, manufacturing, and control (CMC) details to global health agencies is complex, and the process can also vary substantially in different countries. However, there are ways to streamline the path to clinical trials when partnering with an experienced CDMO like Forge that offers integrated regulatory support and a robust regulatory CMC package that has already been reviewed by multiple health authorities.
Our Drug Master Files
One way that Forge helps clients prepare their gene therapies for clinical trials is by streamlining their regulatory filing processes through reference to our Drug Master Files (DMF). DMFs contain information about a manufacturer’s facilities, platform manufacturing processes, analytical methods, packaging, and storing of drug products, and also proprietary starting materials such as plasmids. Multiple clients have already referenced Forge’s DMF, taking advantage of the established documentation with the FDA which can help limit regulatory information requests, conserving valuable resources and often time.
NEW Addition of Plasmid DMF
Forge’s AAV DMF has been referenced by clients multiple times, and the company offers an added layer of support with a plasmid DMF, filed in the U.S. in November 2023. Having a DMF specific to our plasmid DNA offering further streamlines development and manufacturing at Forge. Similar to the benefits of the AAV DMF, a plasmid DMF on file means less information that clients have to prepare and submit in their regulatory filings, and the potential for fewer information requests from the regulatory agency.
Refresh your knowledge about Forge’s AAV DMF in the U.S. and the IND roadmap in this previous post (which includes a brief helpful video!): What the DMF! Spotlight on Forge's Drug Master File.
Conducting Clinical Trials in Canada with Forge’s DMF
For developers looking to conduct clinical trials in Canada, Forge now also offers both AAV and plasmid DMFs filed in Canada as of March 2024. Fortunately for developers, they are nearly identical to the U.S. DMFs, which can harmonize a client’s submission content and reference strategy between FDA and Health Canada.
The IND Filing Process Roadmap and How a Master File Saves Developers Time and Resources
Forge’s DMFs contribute to a client’s IND or CTA filing process. The image below illustrates the Section of an IND or Canadian CTA that is supplemented by the DMFs, significantly reducing time and resources.
Common Technical Document (CTD) Pyramid
The Process
What’s Next?
With active DMFs in the U.S. and Canada, Forge is looking at Australia and Japan next to broaden access and ease the regulatory pathway for clients seeking to file CTAs in other countries. The Forge process has already been assessed in the EU through multiple scientific advice meetings and one CTA, and the team is ready to share learnings with clients seeking access to those regions.
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Integrated Regulatory Services
Forge can provide regulatory support to clients in a variety of ways, including:
- Integrated regulatory strategy support
- Authoring and/or review of client regulatory documents (CMC and beyond)
- Assist with FDA requests for information
- Participation in formal meetings
- Ad hoc consulting services
- Electronic Common Technical Document (eCTD) compliant publishing and submission services
- Forge will maintain a Drug Master File (DMF) for our process with the FDA for client’s CMC documentation
Want to Know More?
Click here to learn more about Forge's regulatory support and speak with our AAV experts.