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Aims to help drug developers navigate the challenges of regulatory compliance, quality assurance, and production scalability.
June 8, 2023
By: Anthony Vecchione
GenScript ProBio, a global CDMO, and Comprehensive Cell Solutions (CCS), a company involved in cell therapy development and manufacturing, entered into a partnership to spearhead the development of cell and gene therapies, offering a unique and integrated solution that spans cell collections and apheresis through cryopreservation of final therapeutics. The partnership aims to accelerate the development of therapies and ensure these therapies are affordable and accessible. GenScript ProBio and CCS aim to provide pharmaceutical, biotech, hospital, and government entities with a comprehensive suite of cell therapy services to help drug developers navigate the challenges of regulatory compliance, cost-effectiveness, quality assurance, and production scalability. The alliance exemplifies how the proximity of experts, clinicians, and patients to manufacturing specialists and facilities in cell and gene therapies can accelerate and simplify the development and delivery of treatments to patients, starting from conceptualization to commercialization. According to the two companies, the initial focus of the collaboration will concentrate on aiding drug developers in advancing cell and gene therapies (CGT) to treat a wide range of indications, including blood cancers, immune disorders, and rare diseases utilizing modalities including, but not limited to, CAR-T therapies, viral vectors (AAV, LVV, RV, HSV), antibodies (mAb, bsAb, ADC), and vaccines (DNA, mRNA, protein). The agreement will provide GenScript ProBio with CCS’s expertise in clinical cell therapy manufacturing and bone marrow transplant services, along with access to blood-related products, apheresis and cell sourcing, process development and optimization, analytical testing, cryopreservation, and fill/finish. In return, CCS will leverage GenScript ProBio’s capabilities in developing and manufacturing antibody/protein drugs, plasmids, viral vectors, vaccines, mRNA, and antibody-drug conjugates. “We’re excited to launch a partnership with GenScript ProBio which expands each of our respective portfolios, and together enables us to support an underserved market of early-stage developers of advanced therapies,” said Tracy Kinjerski, vice president, and general manager of comprehensive cell solutions. “With this collaboration, we will streamline and improve the CGT supply chain with continuity and consistency our clients can rely on. This unique one-stop-shop approach accelerates the journey from development to clinic and commercial supply, ultimately improving the lives of patients.” “Joining forces with New York Blood Center’s Comprehensive Cell Solutions allows us to harness the combined experience and capabilities of both entities to propel innovation and uphold excellence within the cell therapy sector. Our mutual dedication to quality, safety, and efficiency will expedite the development and commercialization of novel cell therapy treatments for patients,” said Patrick Liu, chairman of the board of directors at GenScript ProBio. As part of the strategic alliance, GenScript ProBio and CCS will cooperate in various areas, including technology transfer, process development, clinical manufacturing, regulatory strategy, and commercial manufacturing of cell therapy drug products.
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