Albumedix Announces CBER FDA Drug Master File Acceptance for Recombumin® Elite and Appointment of Director of Regulatory Affairs

Regulatory Assurances for Product Development Using Highest Quality Animal Origin-free rAlb Product Commercially Available

Albumedix Ltd. (‘Albumedix’), the world leader in recombinant human albumin (rHA), announced today that 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). Albumedix’ Recombumin product portfolio is internationally recognized by leading regulatory authorities, all of which are commercially available animal and human origin-free products providing a safe, consistent and reliable solution to enable the formulation and development of advanced therapies and unstable drug candidates. 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.

The DMF filing follows the appointment of Harriet Edwards as Director of Regulatory Affairs. This senior appointment is key to Albumedix’ on-going strategy of ‘empowering excellence’ in the creation of superior biopharmaceuticals through rHA products. Albumedix established the Regulatory Affairs Department to better serve current and future customers, by accelerating products under development. Commenting on Harriet’s 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. Harriet is the ideal person to lead our regulatory activities as we steer our objective to be “Partner of Choice” to enable advanced therapies.”

Harriet brings extensive 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, Harriet 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.

Commenting on the DMF, Harriet said, “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. 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.”

To learn more about Recombumin Elite, Albumedix’ other products or our team of dedicated regulatory experts, please visit www.albumedix.com.

About Albumedix – Dedicated to Better Health

Albumedix is a science-driven, biotechnology company focused on enabling the creation of superior biopharmaceuticals utilizing our recombinant human albumin products. We believe in empowering excellence to enable advanced therapies and unstable drug candidates reach patients worldwide. We are proud to be recognized as the world leader in recombinant human albumin with products and technologies used in clinical and marketed drugs by pharmaceutical companies worldwide. Headquartered in Nottingham, England with more than 100 people all committed to improving patient quality of life. We are just as passionate about albumin and albumin-enabled therapies today as we were when we started 30 years ago.

For further information, please visit www.albumedix.com

About Recombumin

Albumedix have developed a portfolio of rHA products collectively known as Recombumin®, manufactured from proprietary Saccharomyces yeast strains, at ICH Q7 cGMP standards. Recombumin Elite is used in the manufacture of therapeutic pharmaceuticals, medical devices and advanced therapies, as a medium constituent for stem cell culture, and as an ingredient in cell therapy cryopreservation and formulation media. Recombumin Elite is the second Albumedix product to have a DMF; Recombumin Prime has had a DMF filed with the FDA since 2003, in Canada, Australia and New Zealand since 2004 and China since 2019.

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