Rentschler Biopharma received the cGMP Manufacturing Compliance Certificate, following inspection by the U.K. Medicines & Healthcare Products Regulatory Agency (MHRA) at its U.K. site. The company’s advanced therapy medicinal products (ATMP) business was announced in early 2021. The facility is located in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Center in Stevenage.
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 U.K.
“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,” said Robert Panting, PhD, general manager of the ATMP business. “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.”
“By launching Rentschler’s ATMP business, we aim to address an important gap in expertise and support for innovative, early-stage cell and gene therapy programs,” added Christian Schetter, PhD, CSO of Rentschler Biopharma.