With experience maintaining the integrity of millions of samples in our global network of biorepositories, we are the experts in transporting, storing, and handling specialized biological samples and material, from ambient to cryogenic temperatures. Consistent quality. Global network. Dedicated to you.
As the leading service provider to the cell and gene therapy community, we are uniquely positioned with the experience, resources, and global expertise to support our customers on their path towards commercialization.
Our global infrastructure enables customers to seamlessly conduct clinical trials across multiple geographies while providing patients around the world with access to life changing therapies.
Our cryogenic storage and logistics, combined with proven components and validated procedures, allow us to configure and replicate each site to meet the specific requirements of individual clinical trials with minimal variation, regardless of volume or geographic location. This is supported by a global comprehensive and integrated Quality System based on regulatory requirements, industry best practices and highly trained personnel.
Our highly trained experts have the experience with cell and gene therapy clinical trials and the manufacture of biopharmaceutical products to help you navigate many of the challenges which may directly impact product integrity, cost and scalability. We work collaboratively with our customers in every stage of development, from early phase trials through phase III, licensure, and global commercial distribution to develop customized, state-of-the-art solutions.
Leverage our global depot network, fleet of qualified shipper systems, and transportation expertise to distribute your materials worldwide. From ambient to cryogenic shipments, we have the knowledge, equipment, and network to transport your most valuable materials, from cell collection through dose administration.
Our kit production services standardize the cell collection process, helping to maintain integrity and ensure quality pre-manufacture. We design complex, customized clinical collection and administration kits at any temperature, including cryogenic, to meet your sample or cell collection needs, as well as patient administration and post-administration sample collection.
We also provide expert secondary packaging and label design services, encompassing patient specification identification labels and collection containers and complete chain of custody documentation, to ensure that biopharmaceutical products are appropriately and effectively labeled, transported, and handled safely at clinical sites. Our extensive network of cGMP facilities and highly trained experts provide assistance in storing biological and therapeutic materials and packing and transporting them to clinical and biopharmaceutical manufacture sites at cryogenic temperatures.
From ambient to cryogenic shipments, we have the knowledge, equipment, and network to safely store and transport your most valuable materials. From cell collection through dose administration, our global network of GMP facilities is capable of supporting your global supply chain management needs, whether you are executing a small Phase I trial or preparing for commercialization. Leverage our qualified shipper fleets for transportation at any temperature range, with continuous monitoring solutions in place for your high value cryogenic shipments.
Our highly configurable workflows have the flexibility to address the unique requirements of your specific product, whether autologous or allogeneic. These workflows can be validated and standardized by our team of experts to ensure there is consistency in each and every cell collection or drug distribution that takes place, so your cell or gene therapy product is delivered safely and efficiently.
Watch this webinar to learn how we prepare our clients to transition from clinical to commercial.