Residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture
Strasbourg, France, July 20, 2020 – Polyplus-transfection® SA, the leading biotechnology company that supports the gene and cell therapy market by supplying innovative transfection solutions, today announces the launch of the industry’s first GMP-compliant residual test for its PEIpro® product portfolio, transfection reagents designed for process development, pre-clinical, clinical and commercial lentivirus and adeno-associated virus (AAV) production for cell & gene therapies. In addition, Polyplus-transfection® is launching dual sourcing for its PEIpro®-GMP product for late stage and commercialisation cell and gene therapies.
Polyplus has launched the first GMP compliant test for its PEIpro® product range to detect residual transfection reagent during the production of ATMPs (advanced therapeutic medicinal products). GMP guidelines specify manufacturers should be aware of both the residual levels of raw materials used in drug products, and the significance of these results. These regulations ensure manufacturers reliably determine residual raw material levels and thus maintain reproducible safety of ATMPs for patient administration. The Polyplus® test is able to detect and quantify residual PEIpro® throughout the ATMP manufacturing process. As a result, it can be used as a release quality control. The test can be adapted for each ATMP in order to ensure the lowest limits of detection.
In parallel, Polyplus® is the first company globally to introduce dual sourcing for its reagent. This will mitigate the risks to the ATMP industry as the sole provider of the PEIpro®-GMP transfection reagent, the most used transfection reagent worldwide and a critical component for the development and manufacture of ATMPs for gene therapies. The dual sourcing approach enables Polyplus to source its PEIpro®-GMP product from two distinct subcontracting manufacturing plants. Polyplus® is able to ensure sole responsibility and control of the process. ATMP manufacturers are then able to have Polyplus® as a single point of contact whilst benefiting from increased production capacity and shortened lead times.
“As increasing numbers of ATMPs and gene therapies move through late stage trials and commercialisation, demand on GMP reagent supply continues to increase. The complexities of ATMP therapies mean that Polyplus® has to increase its services to the sector alongside increasing its product portfolio,” said Claire Wartel, PhD, director of quality and compliance, Polyplus-transfection®. “As the market leader in transfection reagents to the gene and cell therapy sectors, we have built up nearly 20 years of expertise to help the sector deliver therapies to patients. By offering PEIpro® residual testing and dual sourcing of PEIpro®-GMP to the ATMP market, this enables sector maintenance of regulatory compliance in addition to the lowering of manufacturing and supply risks. Polyplus® will continue to work with the ATMP sector to develop further tests and services for therapies for patients.”
About Polyplus-transfection® SA
Polyplus-transfection® SA is the leading biotechnology company that supports Gene and Cell therapy, along with other biologics manufacturing and life science research with innovative nucleic acid transfection solutions. Polyplus-transfection®’s strengths are 20 years of experience in manufacturing transfection solutions with tailored scientific and regulatory support to accelerate research and clinical development. Based on the Science Park close to Strasbourg (France), Polyplus-transfection® offers an extensive and growing range of transfection reagents available worldwide. For more information, please visit the Polyplus-transfection® web site at: www.polyplus-sartorius.com.