Biologics

Upstream of manufacturing, Cryoport Systems helps biologics developers establish consistent, compliant logistics for critical raw materials, biospecimens, and intermediates. Whether supporting early-phase biologic discovery or clinical-grade material collection, we deliver standardized collection kits and validated shipping systems directly to sites, ensuring Chain of Compliance® and minimizing variability. Materials are transported under strict environmental controls to designated processing or storage facilities, including our IntegriCell™ cryopreservation platform when temperature-sensitive preservation of leukapheresis-derived cellular material is required. With integrated consulting and advisory services for packaging qualification, lane validation, and global regulatory alignment, we streamline upstream workflows to reduce supply chain complexity, accelerate readiness, and maintain the integrity of sensitive biologic inputs.

Downstream of manufacturing, Cryoport Systems provides end-to-end logistics, BioServices and biostorage, and consulting and advisory support that enables the reliable, scalable delivery of biologic products to clinical and commercial destinations. Our validated shipping systems maintain critical temperature ranges for proteins, antibodies, vaccines, and other biologics during global transit. Through our BioServices platform, we offer pick, pack, label, and distribution workflows that can be tailored to product and trial needs, while custom secondary packaging solutions ensure safe handling of specialized containers and components. Our global team supports ongoing trial expansion, lane qualifications, and QP release in the EU, enabling seamless geo-expansion. By consolidating logistics and supply chain management services under one partner, biologics developers eliminate coordination challenges, protect product quality, and gain the flexibility to scale efficiently.

Cryoport Systems supports CDMOs working across the biologics development lifecycle, from preclinical material preparation to late-stage commercial manufacturing, by delivering a unified, compliance-driven supply chain management platform. Biologics programs face distinct challenges: sensitive payloads, strict cold chain requirements, and increasing demand for batch consistency across diverse clinical and commercial settings. We address these challenges head-on with validated, custom-engineered shipping systems, end-to-end traceability, and integrated BioServices and biostorage options that reduce risk and support manufacturing excellence. Whether managing proteins, monoclonal antibodies, or vaccine components, CDMOs gain greater control, standardization, and scalability through our single-vendor model.

Cryoport Systems is the trusted partner for biologics CDMOs seeking to reduce variability, ensure regulatory readiness, and scale efficiently.

We offer tailored support for every stage of the manufacturing process, including raw material handling, intermediate storage, and just-in-time delivery to fill/finish or packaging lines. Our Chain of Compliance® platform captures full shipment history and condition data, enabling batch-level documentation and audit-ready oversight. CDMOs also benefit from our global network of strategically located facilities, Qualified Person (QP) services for EU imports, and consulting expertise that helps proactively qualify shipping lanes and align operations with evolving regulatory expectations. With Cryoport Systems, biologics CDMOs can meet client demands while maintaining the integrity and reliability required in a tightly regulated space.

Clinical trials for biologics demand exceptional coordination and precision, especially when working across multiple geographies and cold chain requirements. Cryoport Systems partners with CROs to manage the logistical complexity of biologics studies, helping to ensure that investigational products, clinical samples, and trial kits are delivered on time and in compliance. By centralizing logistics, packaging, biostorage, and consulting under one partner relationship, we reduce the risk of material loss, delayed dosing, and other hurdles. Our end-to-end supply chain platform brings much-needed standardization and predictability to CRO operations supporting protein, antibody, and vaccine-based studies.

Cryoport Systems helps CROs streamline biologics trial execution with greater speed, reliability, and regulatory alignment.

We offer temperature-validated, custom-engineered shipping systems that align with biologic stability profiles, as well as biostorage to support redundant storage of critical materials like cell banks and just-in-time delivery of materials. Our BioServices teams handle pick, pack, label, and distribution tailored to study protocols, and our consulting and advisory services provide proactive support for shipping lane validation, customs requirements, and risk mitigation. With our global footprint and advanced Chain of Compliance® visibility, CROs can manage complex trial logistics while focusing on their core mission of driving clinical success and accelerating sponsor timelines.

Biologics developers operate in a fast-paced, highly regulated environment where even minor disruptions can quickly turn into costly delays. Cryoport Systems provides a robust and flexible end-to-end supply chain foundation tailored to the needs of biologics sponsors, whether advancing a monoclonal antibody, a therapeutic protein, or a next-generation vaccine. From early-stage clinical material movement to commercial launch logistics, our integrated platform enables developers to reduce complexity, accelerate development timelines, and protect the integrity of temperature-sensitive materials at every touchpoint.

Cryoport Systems empowers biologics developers to move from R&D to commercialization with a unified, audit-ready supply chain built for global scale.

We provide validated cold chain solutions, global biostorage, and customized packaging configurations that ensure temperature stability and protect product integrity from batch release to delivery. Our consulting and advisory teams help sponsors navigate the nuances of global distribution and prepare for regulatory audits. Developers also benefit from real-time visibility, compliance documentation, and the ability to scale quickly across clinical phases and commercial territories. With Cryoport Systems as your supply chain partner, biologics developers can focus on innovation, knowing the logistics are built for success.