Cryoport has entered into a strategic relationship with BioLife Plasma Services, part of the global biopharmaceutical company Takeda, intended to provide consistent, high-quality cellular starting material for use in the manufacture of life-saving cellular therapies.
By bringing together BioLife Plasma Services’ proficiency in apheresis collection and their donation center infrastructure with Cryoport’s life sciences’ world-class capabilities and expertise in temperature-controlled supply chain solutions for the biopharmaceutical industry, the companies aim to establish a standardized, integrated apheresis collection, processing, and distribution solution for cellular therapies. Importantly, the new platform will leverage the cryo-processing expertise of Cell Matters, which Cryoport acquired in late July 2022.
Today, the availability of cellular therapy assets is limited by inflexibility in donation scheduling, a lack of standardization in collection and processing, and challenges inherent towards ensuring compliance with the Good Manufacturing Process (GMP) regulations. This new relationship, which will facilitate strict compliance with applicable GMP regulations, aims to shorten processing and logistics time and standardize collections, contracting, and equipment, in turn, enabling researchers and developers to accelerate cellular therapy programs. Increased access to apheresis, with efficient, scalable and reliable end-to-end processes will benefit not only donors and patients, but manufacturers and the providers of these life-saving therapies.
Commenting on the agreement, Jerrell Shelton, Chief Executive Officer of Cryoport stated, “This strategic relationship with BioLife Plasma Services is a prime example of how our world-class expertise in providing supply chain solutions to the life sciences industry and our expansion into new geographies and services offerings, such as bioservices and cryo-processing, creates exciting new opportunities. Our goal is to streamline the complex processes necessary to treat an increasing number of patients with today’s most advanced cell therapies while ensuring the highest quality and safety standards.”
As a first step, the two companies will establish a new operating platform in Houston, Texas, that will provide end-to-end collection, processing, and distribution services by bringing together Cryoport’s new Houston-based global supply chain center with BioLife Plasma Services’ local donation facilities. Under the leadership of BioLife employees trained in and with extensive knowledge of the fields of cellular therapy and apheresis, cellular collections will be performed by dedicated cellular collection staff in a designated space within the BioLife Plasma Services donation center. With immediate effect, the companies will co-operate in strategic business and marketing activities, with the intent of attracting and building a pipeline of customer demand that will utilize the offering. This will provide the opportunity to define infrastructure and capital commitments required to scale up and potentially expand the offering throughout the United States and Europe over time.
Hema Tallman, Global Head of BioLife Plasma Services added, “Cell therapy is one of the most promising areas of development in healthcare today. This agreement reflects BioLife Plasma Services’ and Takeda’s transformative leadership and commitment to bringing better health and a brighter future to patients worldwide. As we are constantly exploring how we might serve unmet patient needs, this relationship will optimize the use of our first-class facilities, industry-leading capabilities and our skilled workforce of medical professionals and technicians. The operational synergy between plasmapheresis and leukopheresis combined with Cryoport’s leading flexible cryogenic logistics solutions, uniquely positions the two companies to implement and potentially scale a market-leading end-to-end offering across our global donation center network that could enable more patients to benefit from these life-saving therapies.”
Operations are expected to begin in 2022 with apheresis scheduling and collections to be initiated by BioLife Plasma Services in the Houston area. Cryoport will provide cold chain solutions inclusive of packaging, logistics, data management, consulting, program management, cryo-processing, and bioservices.
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