Supply Chain Archives
08/29/2025
The Hidden Risks in Your Supply Chain: How Regulatory Support Can Save Your CGT Program
The temperature-controlled supply chain has become so much more than a straightforward logistics function, especially for advanced therapies. It has quickly evolved into a critical extension of your manufacturing process, your clinical trials, and your path to commercialization. Every step, from sourcing raw materials to delivering the final drug product to patients, must operate within strict regulatory and quality parameters where even the smallest oversight can cascade into regulatory delays, product loss, or even compromised patient safety.
07/31/2025
Earning the Next Trial: How Supply Chain Strategy Helps CROs Build Sponsor Trust
Contract Research Organizations (CROs) play a critical role in the biopharmaceutical industry, often executing clinical trials on behalf of sponsors. They’re tasked with wide-ranging expectations that span numerous functions, including maintaining the balance of operational excellence against regulatory compliance and cost efficiency. This complexity is compounded when clinical trial sites grow to span the globe, additional therapeutic areas, and expanded client populations. In such a competitive market, it’s not enough to simply deliver results. CROs must also build trust.
07/28/2025
Turning Risk into Resilience with Supply Chain Resilience for CDMOs
Contract Development and Manufacturing Organizations (CDMOs) are under more pressure than ever to deliver reliable results in an unpredictable world. From geopolitical instability to material shortages to increasingly complex regulatory expectations, the risks facing clinical and commercial programs have intensified. For CDMOs, these risks don’t just affect their own operations, they directly impact their clients’ ability to bring therapies to patients.
07/25/2025
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.
07/24/2025
Building Better CDMO Supply Chain Readiness
With the accelerating growth of advanced therapies comes increasing complexity in the developing and manufacturing ecosystem. Contract Development and Manufacturing Organizations (CDMOs) sit at the center of this growth, providing critical manufacturing and development services on behalf of their clients, the therapeutic developers. CDMOs require the infrastructure and processes to efficiently scale production, maintain timelines, and ensure product integrity, all while navigating evolving regulatory expectations.
06/28/2025
Celebrating Logistics, the Unsung Hero in Cell and Gene Therapy Innovation
Every National Logistics Day offers a chance to recognize the systems and people that quietly power the innovation engine for Cell and Gene Therapy (CGT). While logistics frequently brings to mind images of trucks and warehouses, cardboard boxes, and tracking numbers, for CGT developers, it’s the infrastructure that protects innovation and ensures that time-sensitive, potentially life-changing treatments reach patients intact and on time. At Cryoport Systems, logistics has never been just about transportation. It’s about Enabling the Outcome™.
06/27/2025
Bridging the Gaps: How Cryoshuttle® Enhances First and Last Mile Resilience
For advanced therapies, the most vulnerable parts of the transportation journey aren’t always the longest. In fact, the greatest risks often occur in the shortest distances. While intercontinental transport and customs clearance are well-known hurdles, both the first and last mile remain highly vulnerable to disruption. Cryoport Systems developed our Cryoshuttle® local pickup and delivery services to help close the gap between global transport lanes and local handling environments.
05/29/2025
Starting Smart: How to Structure an Integrated Supply Chain in Early-Stage CGT Programs
For many academic labs, technology spinouts, and early-stage CGT companies, the temperature-controlled supply chain feels like something to figure out later. But when dealing with highly sensitive starting materials and therapies like CGTs, later can quickly become too late. Whether you’re preparing for first-in-human trials or just beginning to plan for scale, integrated thinking now can spare you time, cost, and complexity later.
05/19/2025
