Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), has received the cGMP Manufacturing Compliance Certificate, following the successful inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) at its UK site in Stevenage.
Dr. Robert Panting, General Manager of Rentschler Biopharma’s ATMP business, said: “MHRA’s approval marks a major milestone for Rentschler Biopharma, and we are excited to offer our services from process and analytical development through cGMP manufacturing. Our team is highly knowledgeable, bringing years of experience in the field of AAV. We provide a tailored program for each client, in line with their needs and stage of development, while working closely with them to move projects forward as rapidly as possible. We are thus continuing the Rentschler tradition of offering a truly client-centric approach with the ultimate goal of helping patients. With our first clients already on board, we look forward to adding other exciting programs soon.”
Following MHRA approval, Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at their Stevenage facility in the UK. The company works to be a true partner to entrepreneurial players to enable them to transform their ideas into real products with the potential to treat and even cure patients with serious and life-threatening diseases.
Rentschler Biopharma's highly experienced team is ready to support ATMP innovators at all stages offering a comprehensive range of services from early process and analytical development through cGMP manufacturing for clinical trials. Connect now using Request Information form below.
Note: This content has been edited by a rapidmicrobiology staff writer for style and content.
