|As part of our ongoing efforts to bring you added value in terms of innovation, quality and regulatory aspects, Biological Industries (BI) announces acceptance by the FDA of a Drug Master File (DMF) for our MSC NutriStem® XF Basal Medium and Supplement. BI’s defined, xeno-free, serum-free medium, designed to support the isolation and growth of human mesenchymal stem cells.
MSC NutriStem® XF is considered in regulatory aspects as an “Ancillary Material” meaning; a material used in the process but is not part of the final product.
The USP defines the requirements of ancillary materials in a general monograph USP<1043> “Ancillary Materials for Cell-,Gene-, and Tissue-Engineered Products”. In accordance to the USP Risk classification (4 tiers), the product is characterized as low- risk.
Drug Master Files are confidential documents submitted to the FDA which outline, in detail, manufacturing and procedural details for drugs or biological materials used in animals or humans. In order to reference information regarding MSC NutriStem® in DMF number 29469, please contact us by filling out the following authorization request in accordance with the instruction in the document Requesting Letter of Authorization form.