Scaling with Confidence for CDMO Supply Chain Alignment
Contract Development and Manufacturing Organizations (CDMOs) play a critical role in the life sciences industry, enabling biopharma innovators to bring new therapies from development to manufacturing to patients around the world. The demand placed on CDMOs has only increased in recent years, especially as cell, gene, and biologic therapies have moved from concept to clinic at unprecedented speeds. While the technical and scientific capabilities of CDMOs have advanced to meet these challenges, one area remains a frequent source of friction and delay… the end-to-end, temperature-controlled supply chain.
The modern CDMO is not only tasked with development and manufacturing responsibilities, but also with ensuring that materials (from starting materials to final drug products) move securely, compliantly, and efficiently across global clinical and commercial programs. This complexity requires more than a set of SOPs or a few vendors. It requires a purpose-built supply chain strategy that is directly aligned with the CDMO’s operational workflows and client deliverables.
The Disconnect Between Manufacturing and Logistics
Many CDMOs inherit fragmented supply chain processes from the biopharma companies they support. In other cases, logistics decisions are handled in isolation, without full visibility into upstream activities. This separation can lead to mismatched timelines, inconsistent documentation, unclear accountability, and costly mistakes when handling time- and temperature-sensitive materials.
This impact is compounded when working with advanced therapies. Delays in customs clearance, insufficient packaging validation, and lack of contingency planning can jeopardize entire programs. These challenges are further complicated for CDMOs serving multiple clients across multiple therapy types, geographies, and trial phases. Without integrated support, every new project introduces risk.
Why Alignment Needs to Start Early
The most successful CDMOs understand that supply chain integration is not something to tack on at the end of development. It begins early in the process, often as early as during the onboarding of a new client program. By involving supply chain integration in the early planning phase, CDMOs can make better decisions about how to handle sensitive starting materials, when to begin with shipping lane qualifications and shipping risk assessments, at what point to bring in packaging performance, how to address biostorage needs, where to work in “just in time” delivery of critical components, and how to create robust contingency planning for global distribution.
An aligned approach also gives CDMOs a clear view of regulatory requirements by geography, enabling smoother transitions between development phases and faster turnaround for trial or commercial launches. This foresight pays off in both operational efficiency and client trust.
Building the Right Supply Chain Infrastructure
At Cryoport Systems, we work hand-in-hand with CDMOs to assess and strengthen their supply chain infrastructure across key areas.
Logistics Integration
We embed our expert logistics planning directly into CDMO workflows. From supporting first- and last-mile transportation to customs navigation and Qualified Person (QP) services that streamline transportation of products into the European Union (EU), our team manages shipments and logistics strategy that allows CDMOs to meet client-specific timelines and material handling needs. All of our shipping systems are designed to ensure traceability and compliance from origin to destination, adhering to the industry’s most robust compliance standards.
Purpose-Built Packaging
Every material and advanced therapy drug product has different requirements, and off-the-shelf solutions rarely deliver the consistency or track-and-trace that’s needed for these specialized shipments. Cryoport Systems has custom-engineered solutions that are designed for cryogenic, ultra-cold, refrigerated, and controlled room temperature conditions that comply with IATA, ISTA, and ASTM standards. Additionally, our team of experts has decades of experience in helping to develop custom products and accessories, including custom secondary packaging or collection kits that add an additional layer of standardization and compliance.
BioServices Support
Our biostorage and sample management capabilities extend a CDMO’s operational footprint without requiring capital investment. From QP oversight in the EU, to clinical sample storage and drug return services, to cGMP biostorage for master cell banks, we help CDMOs uphold regulatory standards and streamline client programs across geographies, with flexible and scalable support that grows or contracts with program needs.
This infrastructure allows CDMOs to focus on the development and manufacturing they do best, while offering their clients a complete, compliant, supply chain platform.
Creating Scalable Models for Long-Term Growth
One of the biggest advantages of supply chain alignment is scalability. When systems are standardized and integrated from the outset, CDMOs can accommodate new clients, new therapeutic programs, and expanded geographic reach without constantly reinventing their approach.
This is especially critical for CDMOs supporting complex, high-value therapeutics like cell and gene therapies. In these cases, having a scalable model for packaging qualification, shipping lane verification, and compliance documentation can shave weeks off timelines and strengthen a CDMO’s ability to win and retain business.
It also allows CDMOs to shift from a reactive model where every issue is solved as it arises into a proactive model where challenges are anticipated and infrastructure evolves in lockstep with scientific advancement.
A Strategic Differentiator in a Crowded Market
As the CDMO landscape continues to grow more competitive, differentiation is no longer a function of technical capabilities alone. Biopharma companies are looking for partners who can deliver results with confidence, predictability, and transparency. That means working with CDMOs who not only manufacture with precision but who also understand the downstream impact of logistics and compliance.
An integrated supply chain partner gives CDMOs the ability to provide a seamless experience to their clients, reduce operational risk, and deliver measurable value throughout a program’s lifecycle.
CDMOs today are expected to move faster, go further, and take on more responsibility than ever before, and as a result, supply chain alignment has become foundational to success. By integrating with a partner like Cryoport Systems, CDMOs gain access to a robust, compliant, and proven platform that allows them to scale with confidence and serve their clients with excellence. The result is a pressure-tested supply chain that’s not just a support function but a strategic asset.
