Recently, Synthgene Biotech (hereinafter referred to as “Synthgene”), Areterna’s parent company, received a confirmation letter from the United States Food and Drug Administration (FDA) for one of our core mRNA raw material products – CAP5 – which have been listed on the FDA website.
Cap5 is a novel cap analog developed by Synthgene and shows improved protein expression in many applications. See the performance data by requesting a digital copy of poster titled “VZV mRNA vaccine with Cap5 (ENE) showed stronger immune response in mice”.
| Cat. No. | Product Description | DMF Number |
| CAP5011 | CAP 5 M7G(5′)VPPP(5′)(2’OMEA)PG 100MM AMMONIUM SOLUTION | 040043 |
By doing this, customers using Synthgene or Areterna’s products can directly cite the DMF filing numbers in their new drug registration documents submitted to the FDA, greatly shortening the product review and evaluation time, simplifying the IND application process, and accelerating the mRNA vaccine/drug application process!
This is not the first time that Synthgene’s mRNA raw material products have obtained FDA DMF filings, bringing the total number of products with FDA DMF filings to 13.
If you are using Synthgene’s DMF filing products and need to reference the DMF number, please email sales@areterna.com to request authorization. Upon receiving and confirming your application, we will provide you with the DMF authorization letter!
About DMF Filing
A Drug Master File (DMF) filing is a submission to the U.S. Food and Drug Administration (FDA) that contains detailed information about the facilities, processes, quality controls, raw materials, packaging materials, and other aspects used in the manufacturing, processing, packaging, and storage of drugs intended for human use.
The main purpose of a DMF is to support regulatory requirements and submissions, such as:
- Investigational New Drug (IND) applications
- New Drug Applications (NDA)
- Abbreviated New Drug Applications (ANDA)
- Export applications
- Amendments and supplements to these applications
Types of DMFs include
- Type I: Manufacturing site, facilities, operating procedures, and personnel
- Type II: Drug substances, drug substance intermediates, and materials used in their preparation or drug products
- Type III: Packaging materials
- Type IV: Excipients, colorants, flavors, essences, or materials used in their preparation
- Type V: FDA-accepted reference information
A DMF holder may authorize customers, partners, or regulatory agencies to reference their DMF in their own regulatory submissions by providing a letter of authorization. This helps protect proprietary information while allowing the FDA to review the necessary data.
The FDA reviews DMFs to ensure that the methods, facilities, and controls used in the manufacturing, processing, and packaging of the drug substances and drug products meet the agency’s requirements for safety, quality, and efficacy.
By having a DMF, companies can streamline the approval process for their drug products by enabling quicker and more efficient reviews, as the detailed information needed by the FDA is readily available and has already been evaluated.