Custom Kit Production
Kit Production for Bench to Bedside Standardization
Custom collection, manufacturing, and administration kits that remove variability as you scale
Clinical programs succeed when every site follows the same steps the same way every time. Standardized kits make that possible from the first collection through final manufacturing and drug administration. Our kit production services provide custom collection kits for clinical sites, manufacturing kits for production, and administration kits for patient dosing, all designed to match your protocol exactly for exceptional reliability. As new clinical or manufacturing sites come online, these kits remove a major source of variability and help teams execute with consistency. That same attention carries forward as programs advance, so your workflows do not drift as complexity grows. The approach keeps samples protected and procedures aligned while timelines stay intact. You gain confidence that every kit in the field supports your goals rather than introducing risk.
Cryoport Systems integrates kit production into a broader supply chain strategy that simplifies operations and reduces risk. Kits are produced in GMP-compliant facilities and prepared for just-in-time or bulk delivery alongside our shipping systems, so they arrive ready for immediate use. This connection between kit production and logistics eliminates delays and reduces the burden on your team. You gain a single partner for critical processes instead of managing multiple vendors, resulting in a streamlined workflow that supports your program today and positions you for scale tomorrow.
Creating Consistency That Scales
Standardization as a safeguard for compliance and growth
Consistency is the foundation of reproducible science. When collection or manufacturing kits vary from site to site or phase to phase, the risk of error grows and timelines slip. Regulators expect documented uniformity, and investors look for evidence that your program is built for scale. Standardized kits deliver both. They remove variability at the point of collection and carry that same discipline into manufacturing, so your processes stay aligned as complexity increases. This approach strengthens compliance and makes late-phase expansion predictable instead of chaotic. It is a practical way to reduce risk today while preparing for tomorrow.
Standardized Collection Kits
Protecting integrity from the very first sample collection
The first interaction with a patient sample sets the tone for everything that follows. If collection procedures differ across sites, data quality suffers and downstream processes become harder to control. Our collection kits are designed to match your protocol exactly for reliability and compatibility with your assays and logistics plan. Each kit is configured to reduce errors and prevent mishandling, even in high-pressure environments. As new sites join your study, these kits hold the line on consistency and keep results comparable. We also build kits to meet regional requirements, such as Europe-specific needs versus U.S. standards, without sacrificing global consistency. You gain confidence that every sample collected supports your goals rather than introducing risk.
Standardize collection to protect every downstream decision.
Collection kits package supplies, but they also can be a source of consistency by standardizing the collection method and materials, reducing the number of things that can go wrong at busy sites. When collections are as high-stakes as they are with autologous cell therapies, for example, there is no margin for error and often no second chances at another draw. Standardizing collection kits for this critical first step increases predictability and creates a strong foundation for reliable manufacturing, while regional flexibility ensures compliance everywhere your trial operates. When accuracy matters most, we make it simple.
Standardized Manufacturing Kits
Repeatable processes that scale all the way into late phase and commercialization
Manufacturing demands rise sharply as programs move toward late phase and commercial scale. Process variation is a frequent cause of delays and investigations, and it often comes from uneven materials and unclear steps. Our manufacturing kits carry forward the same standardization that begins at collection and extend it into production so every site can perform the same procedure with the same materials. Kits are prepared alongside shipping systems for just-in-time delivery or bulk production, and they arrive configured for your facility and your schedule. Samples cryopreserved at our IntegriCell® centers and held in onsite biostorage are released with these kits so everything arrives together and ready for use. The approach reduces handoffs and keeps work aligned with your master batch records and quality controls. It also frees your highly skilled technical staff from spending time assembling kits, allowing them to focus on manufacturing processes that drive yield and efficiency. You benefit from faster starts, fewer deviations, and a smoother path to scale.
Standardize manufacturing to safeguard yield and timeline.
Manufacturing kits turn complex processes into repeatable steps. Teams gain clarity and momentum, and quality groups see fewer surprises. The connection to our full end-to-end supply chain platform that includes integrated logistics, cryopreservation services, and biostorage adds certainty to timing and availability. You can expand capacity without fragmenting your vendor network, and you gain flexibility to manage staffing and slot availability more effectively. Scale becomes a planned progression rather than a risk to be managed day by day.
Standardized Administration Kits
Supporting safe and consistent drug administration at every site
Drug administration is one of the most critical steps in a clinical or commercial program, and variability at this stage can compromise data integrity or even patient safety. Our custom administration kits are designed to standardize this process across all sites, providing the components and instructions needed for accurate and consistent dosing. Each kit includes everything required for administration, like needles, syringes, and ancillary supplies, configured to your protocol and regional requirements. Kits are prepared in GMP-compliant facilities and can be shipped with validated measures to ensure they arrive ready for immediate use. This approach reduces errors while simplifying site workflows while maintaining compliance with global standards.
Administration kits that protect patients and timelines.
Standardizing administration is essential for reproducibility as well as for regulatory confidence. Our kits make this step predictable and efficient, reducing the burden placed on site staff and mitigating risk. Combined with integrated shipping solutions, this approach ensures timely delivery and proper handling from site to destination with condition monitoring and Chain of Compliance® at every stage.
Customization Without Compromise
Flexibility that fits your protocol and your phase
Every program has unique requirements, and rigid templates rarely deliver what you need. Our customization process begins with a detailed review of your protocol and operational priorities. We design kits that include the right components, clear instructions, and layouts that make sense for your workflow. This flexibility ensures compliance without adding complexity for site staff or manufacturing teams. As your program evolves, kits adapt to new phases and new geographies without sacrificing standardization. You gain a solution that feels tailored but still supports reproducibility across every site. That balance of customization and control is what keeps your program moving forward.
Custom kits that protect consistency at every stage.
Customization should never introduce risk. Our approach gives you the flexibility you need while maintaining the discipline regulators expect. Sites receive kits that make their work easier, and sponsors see fewer deviations. Manufacturing teams gain clarity and predictability. Your program benefits from a solution that grows with you without losing control.
A Fully Integrated Supply Chain
One partner for kits, logistics, cryopreservation, and biostorage
Managing multiple vendors for critical processes introduces complexity and risk. Each handoff creates an opportunity for delays, for miscommunication, and even for compliance gaps. Our integrated model eliminates those vulnerabilities by combining kit production within our full end-to-end supply chain platform that brings together logistics, cryopreservation, biostorage and other BioServices, and consulting and advisory services under one roof. Kits are assembled in GMP-compliant facilities and prepared for just-in-time delivery alongside our shipping systems, so they arrive ready for immediate use. Collected samples can move directly into cryopreservation and secure storage, then are released with manufacturing kits when production begins. This connected workflow, customized to your specific program with the flexibility to scale up or down with your needs, reduces fragmentation and gives you a single point of accountability.
One partner. Every critical process. Complete control.
More than convenience alone, this level of supply chain integration delivers risk mitigation. By consolidating services, you reduce variability and strengthen oversight. Your team spends less time managing vendors and more time advancing science. Compliance becomes easier, and scalability becomes a natural progression as your full end-to-end supply chain works as a single system and not a collection of moving parts.
Global Logistics and Scalability
Capacity and coverage for every stage of development
As programs move from early-phase trials to global commercialization, kit production must keep pace. Our infrastructure is built for that challenge. We operate GMP-compliant facilities strategically located near major clinical and manufacturing hubs, supported by the industry’s largest wholly owned fleet of shipping systems. Kits are produced and delivered with precision, whether you need a handful for a pilot study or thousands for a multinational trial. We offer both reusable and single-use models to meet your sustainability goals and operational requirements. This reach reduces transit times and simplifies coordination across regions. It also gives you confidence that scale will not compromise quality or timelines. Wherever your science goes, our systems are ready to support it.
Your kits, delivered anywhere.
Scalability is essential for growth, and we make it seamless. Our processes and services expand with your needs while maintaining the same standards that protect your program today. That means fewer disruptions and more confidence as you advance toward commercialization. Investors see a plan built for scale, and regulators see consistency across every site. When global reach matters, we deliver it.
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Featured Resources
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