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.
New department
The DMF filing follows the appointment of Harriet Edwards as Director of Regulatory Affairs. Albumedix established the Regulatory Affairs Department to better serve current and future customers by accelerating products under development.
Commenting on Edwards’ appointment, Peter Rosholm, CEO, said: “Albumedix is redefining how albumin can be used to facilitate and improve drug development. Harriet’s expertise and focus in regulatory affairs will be invaluable to us as we move our pre-clinical drug candidates towards the clinic.”
Edwards brings extensive experience in regulatory affairs including clinical development in global territories including UK/EU and US, generic pharmaceuticals, pharmacovigilance and medical information.
Commenting on the DMF, Edwards said: “In the rapidly evolving field of advanced therapy medicinal products (ATMPs), there is a growing requirement for GMP grade excipients and raw materials, with increasing emphasis on the provision of supporting regulatory documentation.”
Edwards added: “The successful DMF filing allows Albumedix to provide an enhanced level of regulatory support and a greater level of assurance with regards to our product quality and safety for customers, which is particularly important where Recombumin Elite is used further downstream in the manufacturing process of ATMPs.”
Finally, the new Director explained that plans are in place to further extend the reach of our DMF to other territories in response to customer need.