Albumedix, a recombinant human albumin (rHA) specialist, has announced that the Center for Biologics Evaluation and Research (CBER), one of six main centres for the US FDA has accepted a Drug Master File (DMF) submission for the company’s Recombumin Elite.
CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics, blood products, and cell, tissue, and gene therapies).
The Recombumin portfolio is used in the manufacture of a wide range of biopharmaceuticals including cell and gene therapy applications, vaccines, proteins and peptides as well as medical devices, spanning the product development continuum from early clinical development through to use in approved products.
