Supply Chain Archives
12/11/2025
Setting the Benchmark for Quality in Cell and Gene Therapy Logistics
Quality in cell and gene therapy (CGT) is the foundation that determines whether a therapy reaches a patient intact and effective. As the industry increasingly scales from early development of CGTs to global commercialization, the margin for error narrows as volume and complexity increase. Standards like ISO 21973 provide a framework, but true industry leadership comes from how those standards are applied. In this, Cryoport Systems is setting that benchmark.
12/09/2025
What is ISO 21973 and Why It Matters for Cell and Gene Therapy
Cell and gene therapies (CGTs) are transforming medicine, but the complexity of these treatments introduces new challenges for supply chain management. Every shipment represents a therapy that could change or save a life, which is a level of responsibility that demands precision and transparency, as well as standards that leave absolutely no room for error. ISO 21973:2020 was created to meet that need.
10/22/2025
Beyond the Box: Why Shipping System Qualification Matters in Advanced Therapies
For advanced therapy logistics, quality isn’t limited to what happens inside the manufacturing suite. It extends across the entire supply chain, from packaging and transport to the systems that safeguard material integrity at every handoff. Yet one of the most critical (and often underestimated) steps in ensuring integrity is a shipping system qualification.
09/10/2025
Scale Smarter: How Global Supply Chain Centers Amplify CGT Program Growth
Cell and gene therapy (CGT) programs are among the most complex and sensitive operations in the life sciences. From cryopreservation and biostorage to logistics and regulatory compliance, every step in the supply chain can influence product integrity, clinical timelines, and the scalability of the program. For program heads as well as clinical and technical operations teams, the challenge becomes bigger than merely moving materials. It quickly becomes a challenge of scaling efficiently while maintaining compliance and supporting growth across a global network.
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.
08/20/2025
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.
08/01/2025
Built for Speed: How Cryoport Systems Delivers Without Compromise
In the life sciences, time isn’t just money, it impacts patient outcomes, regulatory compliance, and even trial integrity. When a temperature-sensitive shipment is delayed due to inventory shipper shortages or logistical bottlenecks, the impact can cascade across an entire program. Unfortunately, these scenarios aren’t theoretical. When you’re working with irreplaceable biologic materials, this kind of disruption quickly moves from inconvenient to unacceptable.
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.
07/30/2025
