Protecting the Foundation of Biologics with Flexible, Scalable Cell Banking 

For any biotherapeutic program, your cell bank is the foundation of your manufacturing process. Master cell banks (MCBs), working cell banks (WCBs), and research cell banks (RCBs), represent years of development work and intellectual property. They are irreplaceable assets, and the security of these assets is directly tied to the long-term success of your program. 

Because of their significance, cell banks require absolute precision and regulatory compliance in both their transportation and storage. Any compromise can result in costly setbacks or delayed clinical milestones.  

At Cryoport Systems, our biostorage solutions are designed to protect these assets while also giving therapeutic developers, CROs, and CDMOs the flexibility they need to scale efficiently and streamline manufacturing workflows. With fast-turn availability, including rush requests often fulfilled in under 24 hours, and support for just-in-time delivery, we help programs maximize manufacturing suite utilization and keep therapies moving forward. 

The Role of Cell Banks in Biotherapeutic Development  

Cell banks serve as the foundation of biopharmaceutical production, ensuring consistency and compliance. Research cell banks are critical during preclinical and early-stage studies, enabling researchers to evaluate new constructs and refine manufacturing processes before scaling. Master cell banks are the primary reference materials from which all future cell stocks are derived, providing the genetic stability and reproducibility that regulators require for therapeutic approval. Generated from the MCB, working cell banks are then used for routine production runs, ensuring that each batch of therapy originates from the same genetic source.  

For therapeutic developers, secure cell banking ensures long-term reliability and regulatory readiness. For CROs and CDMOs, secure, reliable cell banking is essential to managing multiple client programs in parallel. In every case, the integrity of cell banks is non-negotiable. They are the single point of truth for biologic production.  

Protecting Assets While Accelerating Scalable Progress 

Traditionally, many organizations have managed their cell banks in-house. But building and maintaining compliant storage facilities requires significant capital investment ad continuous operational resources like specialized freezers and dewars, redundant systems, 24/7 monitoring and data retention, as well as highly qualified staff trained in regulatory standards. These requirements can quickly add up to a heavy burden, especially for small and mid-sized developers.  

Outsourcing cell banking eliminates that burden. By leveraging a specialized provider, organizations gain immediate access to validated infrastructure, expert oversight, and compliance-ready processes without diverting valuable capital away from R&D or manufacturing scale-up. At Cryoport System, our platform is designed to reduce capital expenditure demands while accelerating timelines. Instead of committing resources to maintaining storage systems, developers and their partners can focus on scientific advancement and clinical delivery, knowing their cell banks are secure in a purpose-built environment.  

Complicating matters is the fact that pipelines are rarely static. A single program may begin with small storage needs during early research, then expand to large-scale storage needs as it moves toward late-stage clinical development and commercialization. The ability to scale biostorage capacity seamlessly (without running into disruptions like renegotiations or infrastructure limitations) is critical to keeping pace with development.  

Cryoport Systems has built an end-to-end supply chain platform that easily adapts to these changing requirements. Whether you need to preserve a small RCB, expand capacity for multiple WCBs, or prepare for commercial-scale MCB biostorage, we provide flexible, scalable solutions tailored to your pipeline. This elasticity ensures you only pay for what you need today, while maintaining the ability to grow tomorrow.  

Built for Speed with Fast Turn and Just-in-Time Delivery 

Manufacturing suites are among the most expensive and time-sensitive resources in biopharmaceutical development. When a suite becomes available, developers must be ready to initiate production immediately. Delays in accessing cell banks can result in wasted capacity and delays, which can quickly cascade into downstream impact on clinical trial enrollment and therapeutic delivery.  

This is why just-in-time delivery is so critical. Our infrastructure has been purpose-built to support fast turn and rush delivery, with many requests fulfilled in less than 24 hours. By integrating biostorage within our end-to-end supply chain platform that also supports cryopreservation of leukapheresis-derived starting materials, shipping and logistics, continuous monitoring, and a full suite of BioServices that include critical services to support things like pick, pack, label, cart, and ship, we ensure that cell banks arrive when and where they’re needed, ready to initiate manufacturing runs just in time, exactly on time.  

Beyond speed, the quality and compliance standards at Cryoport Systems grant you access to the industry’s most stringent processes. From our proprietary Chain of Compliance^® to ISO 21973 compliance and advanced, risk-mitigating protocols, our systems and processes span our entire global footprint for consistency and compliance across all our facilities.  

Integrated Support Across the Development Lifecycle to Lay a Stronger Foundation for Biotherapeutics 

Cell banking doesn’t exist in isolation. From early research through commercial production, therapeutic developers rely on a complex ecosystem of CROs, CDMOs, and logistics partners. Too often, gaps between these various stakeholders introduce inefficiencies and risks.  

Cryoport Systems bridges these gaps. Our supply chain platform integrates biostorage with logistics, cryopreservation, and consulting services to provide an end-to-end solution that unifies the development ecosystem. Developers gain the assurance that their assets are secure, while CDMOs and CROs benefit from seamless handoffs and streamlined workflows. This single-vendor approach defragments the supply chain for greater alignment and faster progress from concept to commercialization.  

As pipelines expand and therapies grow more complex, secure cell banking has become a strategic part of the supply chain, directly contributing to program success. Flexible, responsive biostorage allows therapeutic developers, CROs, and CDMOs to protect their most valuable asset while optimizing manufacturing efficiency and accelerating time to market. 

Cryoport Systems delivers more than biostorage. We provide a platform designed to safeguard the foundation of biologics while minimizing capital strain and supporting efficient, just-in-time manufacturing across the development lifecycle. By working with an integrated partner, you can focus on advancing science and serving your patient population, knowing your critical materials are protected at every step.