Compass Biomedical, a wholly owned subsidiary of Arteriocyte, Inc., a leading biotechnology company, announced that the Food and Drug Administration (FDA), Center for Drug Evaluation and Research has accepted the Type II Drug Master File (DMF) submission for its PLUS human platelet lysate. PLUS, a commercially manufactured human platelet lysate, is a cytokine rich replacement for fetal bovine serum (FBS).
With no added heparin required, PLUS offers researchers a true xeno-free alternative to FBS. PLUS human platelet lysate is available as a Clinical Grade and Research Grade product. Clinical grade PLUS has previously been approved by the FDA for use in at least two investigational new drug (IND) submissions for expansion of mesenchymal stems cells (MSCs). PLUS is the only commercially manufactured human platelet lysate (hPL) to have an accepted DMF filing.
A Drug Master File (DMF) is a confidential detailed document submitted to the FDA by a manufacturer that includes the chemistry, manufacturing and controls (CMC) information about their product. An active DMF enables clinical investigators to cross-reference the DMF in their own sponsored IND-application.
"Using the PLUS Drug Master File, our customers can save time and money in preparing their FDA submission since they will not need to include all the details required by FDA. This Drug Master File will enable our cell therapy customers to integrate PLUS into their clinical trial protocols as a replacement for FBS more easily. We have seen a rapid adoption of PLUS by numerous academic and biotech organisations and expect it to grow further as PLUS is used in more clinical trials" said Compass Biomedical CEO, Don Brown.
PLUS is prepared from American Association of Blood Banks (AABB)-screened platelet units using state-of-the-art industrial scale manufacturing techniques and provides a safe, serology-tested product with minimal lot-to-lot variation. PLUS human platelet lysate offers a true xenogeneic-free culture platform that does not require addition of animal-derived anticoagulants (e.g., heparin). PLUS supports the culture of various human cell types, including mesenchymal stem cells (MSCs), dermal fibroblasts, epidermal keratinocytes, and endothelial cells, and has been tested in both traditional culture systems and advanced bioreactor systems.