Gene Therapy

Upstream of manufacturing, Cryoport Systems helps gene therapy developers establish a reliable, reproducible Chain of Compliance® for critical raw and starting materials like donor-derived cells, plasmids, and viral vector components. We provide standardized collection kits and pre-conditioned shipping systems delivered directly to source sites, ensuring regulatory compliance and consistent handling from the outset. Materials are then transported using specialized, temperature-controlled shipping systems to manufacturing sites or directly into secure biostorage for just-in-time delivery. Our consulting and advisory services support early-stage planning, offering risk assessments, shipper and packaging validation, and global shipping lane qualification. By consolidating services into a unified network, we eliminate the coordination burden and variability that can delay vector production and compromise manufacturing.

Downstream of manufacturing, Cryoport Systems enables the precise, compliant movement of high-value gene therapy products across global clinical networks. Whether shipping viral vectors, final drug product, or ancillary components, our validated shipping systems maintain strict environmental control and continuous monitoring throughout the journey. Our advanced BioServices streamline logistics with tailored pick, pack. label, and distribution workflows, while custom secondary packaging development supports specialized formats and accessories. As trials scale, our team helps navigate regional requirements, qualify new sites, and manage qualified person (QP) release for European shipments. From final product distribution to patient-facing logistics, our single-vendor model ensures consistent quality, mitigates delays, and gives developers the flexibility to scale and expand without added operational complexity.

Cryoport Systems supports CDMOs engaged in gene therapy development and manufacturing, recognizing that material sensitivity, evolving regulatory requirements, and compressed timelines demand flawless execution across the supply chain. From plasmid and vector production through final drug product distribution, our integrated platform offers CDMOs complete control and visibility. Whether you’re managing raw materials, working with temperature-sensitive intermediates, or launching a global clinical program, our packaging, logistics, BioServices and biostorage solutions are engineered to maintain the identity, integrity, and compliance of each component at every stage of manufacturing. With deep experience supporting viral vector workflows, our team partners with CDMOs to streamline handoffs, prevent loss, and scale effectively across increasingly complex programs.

Cryoport Systems is the trusted single-vendor solution for CDMOs, delivering standardization, traceability, and global scalability across every phase of gene therapy manufacturing.

We support CDMOs with end-to-end infrastructure designed for precision, with validated packaging, secure and scalable biostorage, GMP-compliant shipping systems, and consultative guidance for packaging qualification, lane validation, and regulatory readiness. Our Chain of Compliance® platform ensures full visibility into every shipment’s condition and location, while our qualified person (QP) services enable seamless importation into the EU. As gene therapy programs evolve toward commercial readiness, Cryoport Systems provides CDMOs with the operational flexibility and compliance discipline needed to support clients at the highest level of quality.

Cryoport Systems partners with CROs to remove logistical uncertainty from clinical trial execution in gene therapy, helping studies run smoothly from first patient to global site activation. Our integrated platform simplifies the movement of high-value materials (including viral vectors, starting materials, and investigational products) across borders, time zones, and trial phases. Whether managing site-to-site shipments, cold chain kit distribution, or temperature-controlled delivery to patients, we equip CROs with the tools to stay on schedule and in compliance. By consolidating logistics, packaging, BioServices and biostorage, and consulting and advisory support under one roof, we help CROs avoid common fragmentation pitfalls that can delay enrollment, waste product, or compromise trial data.

Cryoport Systems enables CROs to manage complex gene therapy trials with greater efficiency, oversight, and confidence.

Our services are purpose-built for trials involving advanced biologics and sensitive payloads. We offer standardized kit production, industry-leading shipping systems, centralized biostorage, and flexible BioServices to meet varying protocol needs. Our consulting and advisory team supports early-stage lane qualification and real-time troubleshooting, while our Chain of Compliance® provides the audit-ready documentation required for gene therapies. As trials expand globally or pivot quickly between phases, Cryoport Systems empowers CROs to stay ahead, minimizing risk while enhancing delivery speed and quality.

For gene therapy sponsors, successful execution depends on a supply chain that is as robust and innovative as the science itself. Cryoport Systems supports therapeutic developers with an integrated network that protects product integrity, accelerates timelines, and reduces operational complexity. Whether developing AAV-based therapies, lentiviral vectors, or other gene-modifying modalities, we provide the infrastructure and expertise to manage each material, from plasmid DNA to final drug product, across its lifecycle. By unifying packaging, logistics, biostorage, and consulting services under one partner, developers gain a predictable, scalable supply chain built to support regulatory scrutiny and rapid growth.

Cryoport Systems delivers the specialized logistics and BioServices gene therapy developers need to bring breakthrough therapies from concept to clinic and beyond.

Our model is built around precision and flexibility. We offer validated cold chain solutions for every payload type, with full visibility into condition and location at every handoff. Our early-phase consulting and advisory support helps establish foundational shipping lanes, packaging protocols, and regulatory pathways, while our BioServices and qualified person (QP) oversight streamline clinical execution and global expansion. Whether preparing for IND submission, managing late-phase trials, or launching commercially, gene therapy developers rely on Cryoport Systems to minimize risk, maintain quality, and keep therapies moving forward.