Albumedix announced the Center for Biologics Evaluation and Research (CBER), one of six main centers for the U.S. Food and Drug Administration (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 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.
Additionally, Albumedix has announced 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.
“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. Harriet is the ideal person to lead our regulatory activities as we steer our objective to be “Partner of Choice” to enable advanced therapies,” Peter Rosholm (CEO) said.
Edwards brings experience in regulatory affairs including clinical development in global territories including UK/EU and US, generic pharmaceuticals, pharmacovigilance and medical information. Prior to joining Albumedix, Edwards was Senior Regulatory Affairs Manager at a leading global clinical and early development CRO/CDMO, and Drug Safety/Regulatory Affairs Officer for a pharmaceutical company specializing in generic medicines. With experience across multiple therapeutic areas, Harriet has been responsible for authoring, coordinating and overseeing all required regulatory documentation to ensure timely delivery of regulatory submissions (including CTAs, INDs and MAA variations) and providing strategic advice to project teams and sponsors. Harriet holds three first class science degrees, including two MSc’s - one in Pharmacology from Nottingham Trent University, and the other in Regulatory Affairs from University of Hertfordshire/TOPRA, where she received the Valorie Skeffington award for highest achievement.
“The successful DMF filing for Recombumin Elite marks a huge milestone for Albumedix, both from a regulatory perspective but also a company-wide achievement. 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 said. “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. The DMF assures our customers that Albumedix can provide robust and comprehensive documentation, helping to alleviate the regulatory burden of product development. Plans are in place to further extend the reach of our DMF to other territories in response to our customers’ needs.”