About Cryoport

Cryoport, Inc. (Cryoport) operates as a global leader in serving the life sciences industry as a provider of integrated temperature-controlled supply-chain solutions supporting the life sciences in the biopharma/pharma, animal health, and reproductive medicine markets. With 48 strategic international locations, Cryoport’s global platform provides mission-critical solutions to over 3,000 customers working in biopharma/pharma, animal health, and reproductive medicine companies, universities, research institutions, and government agencies. The company’s platform of solutions and services together with its global team of over 1,000 dedicated colleagues delivers a unique combination of innovative supply chain technologies and services through its industry-leading brands, including Cryoport Systems, IntegriCell, CryoStork, MVE Biological Solutions, CRYOPDP, and CRYOGENE. Cryoport’s advanced temperature-controlled supply chain platform is designed to support the global distribution of high-value commercial biologic and cell-based products and therapies regulated by the United States Food and Drug Administration (FDA), the European Medicines Association (EMA) and other international regulatory bodies. Cryoport’s solutions are also relied upon for the support of pre-clinical, clinical trials, Investigational New Drug Applications (IND), Biologics License Applications (BLA), and New Drug Applications (NDA) with the FDA, as well as global clinical trials initiated in other geographies, where strict regulatory compliance and quality assurance is mandated. As of December 31, 2022, the company supported 654 clinical trials, of which 79 were in Phase 3, and ten (10) commercial therapies. In addition, Cryoport supports the animal health market and the human reproductive market on a global basis with its advanced supply chain platform. Markets Cryoport serves the life sciences industry as a trusted provider of integrated temperature-controlled supply chain solutions supporting the biopharma/pharma, animal health, and reproductive medicine markets. Biopharma/Pharma: In the biopharma/pharma market, the company focuses on supporting biopharma/pharma companies, primarily, in the saving of lives. From clinical research and development to clinical research organizations, to clinical trials for cell and gene therapies, to the storage and delivery of life-saving commercial cell and gene therapies, to the customers of biopharmaceutical /pharmaceutical organizations, to crucial points of care, the company strives to address fundamental to advanced temperature-controlled storage, transport, packaging, fulfillment, and information challenges. Animal Health: In the animal health market, the company provides support for animal reproduction, which primarily involves the production of protein. The company also supports medicine for the health of recreational and companion animals. Animal disease prevention and control rely on the safe transport and storage of vaccines and other biological materials around the world. The company’s secure temperature-controlled supply chain solutions are designed to help avoid costly delays through nonstop monitoring and complete fleet management from and to the origin and destination points as well as provide cryobiological storage equipment. Reproductive Medicine: In the human reproductive medicine market, the company focuses on supporting the creation of human life. This is primarily accomplished by supporting In-Vitro Fertilization (IVF), and related technologies, along with fertility networks globally. IVF materials receive one-on-one handling and individualized attention during the entire logistics process. Acquisitions In April 2022, the company acquired Cell&Co BioServices in Clermont-Ferrand, France with additional operations in Pont-du-Château, France to further enhance its existing global temperature-controlled supply chain capabilities. Cell&Co BioServices is a bioservices business providing biorepository, kitting, and logistics services to the life sciences industry and a part of Cryoport Systems’ Global Supply Chain Center Network. In July 2022, the company acquired Polar Expres based in Madrid, Spain, which provides temperature-controlled logistics solutions dedicated to the life sciences industry. Polar Expres operates logistics centers in Madrid and Barcelona supporting the rapidly growing life sciences market. This acquisition further expanded CRYOPDP’s footprint in the EMEA region. In July 2022, the company also acquired Cell Matters based in Liège, Belgium, a company with cryobiology expertise, providing cryo-process optimization, cryoprocessing, and cryopreservation solutions to the life sciences industry. This acquisition is tied to Cryoport Systems’ new initiative to establish standardized, integrated apheresis collection, processing, biostorage, and distribution solutions for cellular therapies. The new platform will leverage the cryo-processing expertise of Cell Matters (rebranded IntegriCell™) to provide consistent, high-quality cellular starting material for use in the manufacture of life-saving cellular therapies. Cryoport Products and Services The company continuously expand its products and services across the supply chain with innovative, technology-centric solutions to support the development and distribution of life sciences products and therapies. The company’s suite of market leading products and services include, but are not limited to the following: Cryoport Express Shippers - Cryoport Express Shippers range from liquid nitrogen dry vapor shippers (-150 degree Celsius) to the company’s C3 Shippers (2-8 degree Celsius), which are powered by phase-change materials. The Cryoport Express Shippers are precision-engineered assemblies that are reliable, cost-effective, and reusable or recyclable. The company’s liquid nitrogen dry vapor Cryoport Express Shippers utilize an innovative application of ‘dry vapor’ liquid nitrogen technology and, most often, include a SmartPak Condition Monitoring System. Cryoport Express Shippers meet IATA requirements for transport, including Class 6.2 infectious substances, are also ISTA Transit Tested certified and carry the CE (Conformite Europeenne) mark demonstrating conformance with European Union (EU) health, safety, and environmental protection standards. Cryoport ELITE Shipper Systems Cryoport ELITE -80°C Gene Therapy Shipper - As the first product in a high-performance line of Cryoport ELITE Shippers, the company has designed a best-in-class family of -80°C shippers that have superior temperature management properties, as well as incorporate next generation protection, handling, and data collection and management systems, including the company’s SmartPak Condition Monitoring System. The Cryoport ELITE shipper line has been developed in conjunction with one of the leaders in the gene therapy space for clinical and commercial gene therapy distribution. The ELITE™shipper platform will be launched during the first quarter of 2023. Cryoport ELITE Cryosphere Shipper - The second product in the new high-performance line of Cryoport ELITE Shippers is the Cryosphere, which is a revolutionary gravitationally stabilized shipper that is the most advanced cryogenic shipper to support the cell and gene therapy and other life sciences markets. This shipper is designed to passively stabilize the payload through an internal gravitational sphere, thereby keeping the payload in an upright orientation regardless of the external shipper orientation. This innovative technology further mitigates one of the key risks during storage, handling, and transport, which is maintaining constant cryogenic temperatures. In addition, the Cryosphere has advanced shock and vibration absorption properties to further protect its payload and it will be outfitted with Cryoport’s state-of-the-art condition monitoring systems. It has also been designed to be ergonomically friendly for the company’s manufacturing and clinical partners providing a better user experience than other products in the market. The Cryosphere is expected to be launched during the second quarter of 2023. Cryoport Consulting Services – Cryoport Consulting Services functions in an expert advisory capacity to offer solutions to address risk factors present in temperature-controlled supply chain and logistics. To develop tailored scalable solutions, the company’s cross-functional team collaborates with its clients to understand supply chain, logistics, time, shipper, and packaging concerns. Cryoport Consulting Services employs a structured approach to managing, executing, and developing risk mitigation plans. The company’s clients benefit from its quality driven processes and solutions delivered by its high integrity team leveraging industry-standard best practices and years of experience partnering with leading regenerative medicine companies from early clinical through post-commercialization. Service solutions range from comprehensive physical, thermal and shipping qualifications of shipping systems and/or packaging to developing user-friendly custom packaging solutions focused on the challenges unique to the company’s regenerative medicine customers. Through its Packaging Center of Excellence the company serves its clients in biopharma/pharma, animal health, and reproductive medicine markets by providing state-of-the-art customized packaging, testing, qualification capabilities and a host of other services. Cryoport Bioservices – In June 2022, Cryoport Systems launched its first two Global Supply Chain Centers in Houston, Texas and Morris Plains, New Jersey. These state-of-the-art facilities combine the company’s existing logistics processes and capabilities with its new, cutting edge Bioservices infrastructure – all under one roof, as Cryoport Systems’ Global Supply Chain Center Network. These new Cryoport Systems’ Global Supply Chain Centers offer a new and fully integrated approach designed to support cell and gene therapies, including comprehensive controlled temperature storage, fulfilment, kit production, secondary packaging, labelling of therapeutic products and GMP (good manufacturing practices) raw materials storage along with advanced world class logistics. In April 2022, the company acquired Cell&Co BioServices in Clermont-Ferrand, France with additional bioservices operations in Pont-du-Château, France to accelerate the setup of its bioservices capabilities in the Europe, the Middle East and Africa (EMEA) region. Further expansion of the Cryoport Systems’ Global Supply Chain Center Network is expected to include additional sites in the Americas, EMEA and the Asia Pacific (APAC) regions. The addition of these facilities and services provides for the company’s clients’ increasing need for comprehensive and integrated solutions offerings and the expected growth in the global biostorage and bioservices markets, which are driven by the acceleration of clinical trials and the commercialization of regenerative medicine therapies on a global basis. CRYOGENE - provides unparalleled solutions for the provision of pre-clinical temperature-controlled biological materials management services to the life sciences industry. These services include comprehensive specimen storage, processing, collection, and retrieval at the company’s expanded CRYOGENE operations in Houston, Texas, which is a cGMP-compliant operation. CRYOGENE is in the planning stage to expand its operations to San Antonio, Texas and Philadelphia, Pennsylvania. CRYOPDP Temperature-controlled Logistics - CRYOPDP is a specialist providing global and innovative temperature-controlled logistics solutions to the biopharmaceutical/pharmaceuticals industry. CRYOPDP operates with expertise an exhaustive range of temperature-controlled logistics services including temperature-controlled packaging and premium transport solutions from cryogenic temperature (-196°C to -150°C) to controlled ambient (+15°C to +25°C). IntegriCell Services – in conjunction with its recent acquisition of Cell Matters in July of 2022, Cryoport has launched its IntegriCell service platform. The IntegriCell platform is designed as a first-to-market, fully standardized apheresis collection and cryo-processing platform that is expected to be built out on a global basis. The platform services include apheresis/leukapheresis collection, Cryoshuttle transportation services, cryo-process optimization, cryo-processing services, and biostorage to provide a more consistent starting product and increased patient accessibility into the community care setting for regenerative medicine therapies. MVE Biological Solutions MVE Biological Solutions’ Fusion Cryogenic System - is the world’s first and only self-sustaining cryogenic freezer. The MVE Fusion can operate as a stand-alone unit, requiring no on-going liquid nitrogen supply or connection to an external liquid nitrogen source. Fusion cryogenic freezers are a perfect solution for remote geographic locations, isolated laboratories, high elevation facilities, or facilities without existing liquid nitrogen infrastructure. MVE Biological Solutions’ Vario Cryogenic System – is an innovative cryogenic freezer system that can support temperatures anywhere between -20°C and -150°C. In addition to providing greater flexibility, the Vario series of cryogenic freezer systems provide effective and consistent temperature profiles with less than 1% of the power consumption and a 70% reduction in overall operating cost savings compared to traditional mechanical freezers. Customer Types The company’s major customer types include: Clinical Trials - Every pharmaceutical or biopharma company developing a new drug or therapy must seek development protocol approval by regulatory bodies, e.g., the FDA or EMA. Usually, these agencies require clinical trials to be designed to test the safety and efficacy of the potential new drug or therapy among other things. Biotechnology and Diagnostic Companies - The biotechnology market includes basic and applied research and development in diverse areas, such as stem cells, gene therapy, DNA tumor vaccines, tissue engineering, genomics, blood products, etc. Companies participating in the foregoing fields rely on temperature-controlled storage and transport of specimens in connection with their research and development efforts, for which the company’s suite of global temperature-controlled supply chain solutions are ideally suited. Cell Therapy Companies - Rapid advancements are underway in the research and development of cell-based therapies, which involve cellular material being infused into a patient. In allogeneic cell therapies, the donor is a different person than the recipient of the cells. Once cells are manufactured into a cellular therapy, in either case, they must be stored and shipped cryogenically for which the company’s Cryoport Express and Cryoport ELITE Shipper solutions, CRYOPDP logistics solutions, CRYOGENE’s biostorage capabilities, and MVE Biological Solutions’ cryogenic systems are ideally suited. Contract Research, Development & Manufacturing Companies - Increasingly, as evidenced by the company’s strategic partnership with Lonza, CRO’s and Contract Development and Manufacturing Organizations (CDMOs) are engaging its services exclusively in conjunction with their contract services platform to provide a higher level of service to its mutual client base. Central Laboratories - With the increase and globalization of clinical studies and trials, supply chain support has become more complex and ensuring sample integrity has become more challenging. Fertility Clinics and IVF - Maintaining cryogenic temperatures during shipping and transfer of In Vitro Fertilization (IVF) specimens like eggs, sperm, or embryos is critical for cell integrity to retain viability, stabilize the cells, and ensure reproducible results and successful IVF treatment. Animal Health Companies – The company’s focus in Animal Health is supporting protein production. The company provides cryogenic storage dewars to bovine breeders for the support of beef and milk production through artificial insemination, on a global basis. The company also provides temperature-controlled supply chain services for advanced vaccines, primarily for aviary. MVE Biological Solutions and Cryoport Systems are its primary participants in this market. The company also supports therapies for companion and recreational animals which include canine and equine, in addition to veterinary laboratories and other animal related reproductive and health areas. University and Health Center Research Facilities - Research is conducted globally at major universities and health centers and is often done in collaboration with others which requires using Cryoport Express Shippers, CRYOPDP, and/or CRYOGENE services. The company’s broad line of products and services provide solutions tailored to these institutions and individual researchers. Sales and Marketing The company serves clients throughout the life sciences industry and its sales and marketing initiatives are global in nature, focusing on addressing each customer’s pain points and anticipated needs through best-in-class temperature-controlled supply chain solutions. The company’s marketing teams design and implement targeted digital campaigns to support its commercial strategy and promote its portfolio of solutions and capabilities. The company’s marketing initiatives are designed to drive its business development, program management, consulting, other related activities and increase awareness of its advanced temperature-controlled supply chain solutions. Patents, Copyrights, Trademarks, and Proprietary Rights The company owns approximately 60 issued patents and have more than 100 pending patent applications throughout the world. The company’s patents generally protect certain aspects of its products and related technology. Government Regulation The company’s Cryoport Express and ELITE Shippers meet Packing Instructions 602 and 650 and are certified for the shipment of Class 6.2 Dangerous Goods per the requirements of the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air and IATA. The company’s present and planned future versions of the Cryoport SmartPak Condition Monitoring Systems will likely be subject to regulation by the Federal Aviation Administration (FAA), Federal Communications Commission (FCC), FDA, IATA and possibly other agencies. The company’s MVE Biological Solutions cryogenic stainless-steel freezers and aluminum dewars are certified to the Medical Device Directive (MDD) in the EU. History CryoPort, Inc. was founded in 1999.