Getting a clear understanding of regulatory requirements around the quality of raw materials can be challenging. There is currently no global harmonization and existing guidelines can be interpreted in different ways.
We are actively involved in many of the regulatory initiatives and discussions and have more than 25 years of experience in the development and GMP manufacturing of cell and gene therapy products. This unique background allows us to offer you expert regulatory support and assist you with your regulatory approval process.
We offer the following regulatory support on GMP grade raw materials:
• Auditing of our production site upon request
• Drug Master Files for cross-reference (USA only)
• Regulatory Support Files, TSE Certificates (upon request)
• Change notifications prior to relevant changes (with or w/o QM agreement)
• On-demand customized documentation for regional authorities
Contact our Regulatory Support Team for all your regulatory requests & questions:
Drug Master Files (USA only)
We have submitted Drug Master Files (DMF) to the US Food and Drug Administration (FDA) for most of our GMP grade products to support our US customers’ submissions to the FDA.
The DMF contains confidential information on a product’s chemistry, manufacture, raw materials, stability, purity, impurity profile, and packaging. This information may be used to support an Investigational New Drug (IND) application, Biologic License Application (BLA), New Drug application (NDA) or Abbreviated New Drug Application (ANDA), another DMF, an export application or amendments to any of these.
Please note that cross reference by the FDA is only possible in combination with an IND, BLA, NDA or ANDA application. To date, no comparable DMF System for biological raw materials is in place in Europe.
A DMF is a regulatory instrument that provides confidential detailed information about the manufacturing conditions of drugs or biologics for use in humans or animals. Manufacturers can submit this document to the FDA. It enables the manufacturer to protect its intellectual property by allowing the FDA to review the information in support of a third party’s submission.
CellGenix DMFs are Type II DMFs which are submitted in Electronic Common Technical Document (eCTD) format.
We currently offer DMFs for the following products:
Cytokines & Growth Factors:
CellGenix® GMP rh EGF
CellGenix® GMP rh FGF-2
CellGenix® GMP rh Flt-3L
CellGenix® GMP rh GM-CSF
CellGenix® GMP rh IL-1β
CellGenix® GMP rh IL-2
CellGenix® GMP rh IL-3
CellGenix® GMP rh IL-4
CellGenix® GMP rh IL-6
CellGenix® GMP rh IL-7
CellGenix® GMP rh IL-15
CellGenix® GMP rh IL-21
CellGenix® GMP rh SCF
CellGenix® GMP rh TNF-α
CellGenix® GMP rh TPO
The FDA only has access to a DMF in conjunction with a letter of authorization that permits the FDA to reference the DMF. You can initiate a cross reference authorization for a CellGenix DMF by submitting a letter of authorization request. After receiving your request, we will inform the FDA that they have our approval to include the CellGenix DMF in your FDA submission.
Submit your DMF Letter of Authorization Request