Thermo Fisher Scientific has submitted Drug Master Files to the US Food & Drug Administration for many of our products. Wherever you are in the world, contact our industry-leading regulatory experts to cross-reference a DMF or to provide information for your submissions to various government agencies.

DMF Overview

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential, detailed information about facilities, processes or articles employed in the manufacturing, processing, packaging and storing of one or more drugs intended for use in humans or animals. Neither law nor FDA regulations require the submission of a DMF. The file is submitted solely at the discretion of the holder and is never approved or disapproved. The FDA will review information submitted only upon written request and reference given by the holder of the DMF. The DMF holder provides the written authorization to the FDA that allows the review of the Master File to support another regulatory application. The information contained in a DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), a Biologics License Application (BLA) , another DMF or amendments to any of these. Thermo Fisher Scientific submits DMFs on those products that have significant potential to be used in a manufacturing environment by our customers. There are several types of DMFs; we submit Type II files which are classified as either "Drug Substance," "Drug Substance Intermediate," or "Material" (used in the preparation of a drug product).

Typical Content of a DMF

 

A typical DMF that Thermo Fisher Scientific files for a cell culture product (such as nutrient media) may include the following:

  • A summary of all significant steps and controls in the manufacturing process
  • Product name and description
  • Formulation content, including raw materials used, specifications and other relevant information
  • Master production record
  • Product specifications
  • Packaging specifications

DMF Letter of Authorization

As a Thermo Fisher Scientific customer using one of our Gibco™ products in a manufacturing process, you may request that we provide reference authorization to our Drug Master File(s) in support of a submission or filing that you have made to the FDA. To initiate the reference authorization of our DMF, you must submit a Letter of Authorization request to Thermo Fisher Scientific requesting that we provide a DMF Letter of Authorization to the respective FDA Center. Once we have your request, we will advise the FDA that a Thermo Fisher Scientific Drug Master File is relevant to its review and that the agency has our approval to make that DMF part of your submission.

Confidentiality

All information contained in a Drug Master File is considered confidential to the holder. Neither the FDA nor other outside party may have access to or release the file without the holder's consent.

A consolidated Drug Master File (DMF) has been submitted to:

  • A consolidated Drug Master File (DMF) has been submitted to:Center for Drugs Evaluation and Research (CDER) - DMF # 17923 for Cell Culture Media
  • Center for Drugs Evaluation and Research (CDER) - DMF #25125 for Human Growth Factors
  • Center for Biologics Evaluation and Research (CBER) - CBER Requests can be referenced through CDER

A DMF can be referenced for catalog and customized versions of the following products:

DMF 17923 Products manufactured in Grand Island, New York, USA:

Adenovirus Expression Medium (AEM) – 12582 CD CHO Media (25 X Concentrates) 0970194, 0970256, 0970360, 0970193, 0080044 FunctionMAX TiterEnhancer  A15010
CD CHO Medium – 10743 CHO CD Efficient Feed Kit  A-10241 DMEM/F12  11330
CHO S SFM II – 12052 CELLstart CTS A10142 HEPES  15630
Human Endothelia - 11111 StemPro MSC SFM  XF A10675 B27 XenoFree CTS  A1486701
CD Hybridoma Medium - 11279 OptiMEM I 31985 T Cell Serum Replacement Media Supplement  A24334
Hybridoma SFM - 12045 GlutaMAX I CTS  A12860 Polyamine Supplement (100x)  A12583DK
Opti-Pro SFM – 12309 CD EfficientFeed C AGT A13275 HPFM-12  06-5056
SF 900 II SFM - 10902 Hibernate A CTS A1370501 HPFM-15  08-5033
VP SFM – 11681 Hibernate E CTS A13706 RPMI – 11875
CD 293 Medium – 11913 Knockout DMEM CTS  A12861 CD Hybridoma AGT A27377
293 SFM II – 11686 Knockout DMEM/F12 CTS A13708 CTS Essential 8 Medium A26561
Freestyle 293 Expression - 12338 Neurobasal A CTS A13710 EfficientFeed B+ AGT Supplement  A23050
TrypLE ™ Select - 12563 Neurobasal  CTS  A13712
EfficientFeed C+ AGT Supplement  A23051
CD OPTI CHO 12681 Synth-a-Freeze CTS A13713
Dynamis AGT Medium  A26175
CD CHO 5 X Feed Kit, 07-5004, 07-5005, 07-5006, 07-5007 CD FortiCHO  A11483  

DMF 25125 Products manufactured in Frederick, Maryland, USA:

Recombinant Human Interleukin-2 (IL-2) CTS™  CTP0021 Recombinant Human Tumor Necrosis Factor-a (TNF-a) CTS™  CTP3011 Recombinant Human Transforming Growth Factor-β1 (TGF-  β1) CTS™  CTP9211
Recombinant Human Interleukin-2 (IL-2) CTS™  CTP0023 Recombinant Human Tumor Necrosis Factor-a (TNF-a) CTS™  CTP3013 Recombinant Human Transforming Growth Factor-β1 (TGF-  β1) CTS™  CTP9213
Recombinant Human Interleukin-4 (IL-4) CTS™  CTP0041 Recombinant Human Interleukin-6  (IL-6) CTS™  CTP0061 Recombinant Human Flt-3 Ligand CTS™  CTP9411
Recombinant Human Interleukin-4 (IL-4) CTS™  CTP0043 Recombinant Human Interleukin-6  (IL-6) CTS™  CTP0063 ecombinant Human Flt-3 Ligand CTS™  CTP9413
Recombinant Human Interleukin-7 (IL-7) CTS™  CTP0071 Recombinant Human Fibroblast Growth Factor-basic (FGF-basic) CTS™  CTP0261  
Recombinant Human Interleukin-7 (IL-7) CTS™  CTP0073 Recombinant Human Fibroblast Growth Factor-basic (FGF-basic) CTS™  CTP0263  
Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) CTS™ Recombinant Human Stem Cell Factor (SCF) CTS™  CTP2111  
Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) CTS™ CTP2011 Recombinant Human Stem Cell Factor (SCF) CTS™  CTP2113  

DMF 030844 Products manufactured in Paisley, Scotland

CD CHO AGT™ – 12490 CD Hybridoma AGT™ – 12372 CD Hybridoma AGT™ - A29890