Articles Archives

Building the Infrastructure to Enable Patient Access to Advanced Therapies: A Deep-Dive with Dominic Clarke, VP of Technical Operations

Following Pharmaceutical Commerce’s podcast with Adam Fox, Chief Quality & Regulatory Affairs Officer at Cryoport Systems, we wanted to explore several topics that deserve a deeper look. As cell and gene therapies continue to advance, quality leaders are discovering that supply chains have become an extension of the quality system itself.

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Streamline Cell Therapy Operations by Reducing Requalification

Advancing a cell therapy program into late-stage clinical development is an exciting milestone, but operationally complex. As organizations prepare to expand manufacturing capacity or onboard additional clinical sites, scaling operationally can be just as demanding as advancing the science. One of the most overlooked obstacles is requalification. While qualification activities are a necessary component of maintaining quality and regulatory compliance, repeated requalification events consume significant time and budget. Straightforward expansion efforts can quickly become a series of validation exercises and cross-functional reviews that extend timelines and increases costs.

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Expert Q&A: Going Deeper on Early Supply Chain Strategy for CGT Programs

Advanced therapy developers rarely have the luxury of perfect timing. Programs are often moving toward the next milestone with limited resources, data that’s evolving in real time, and pressure to make decisions before every variable is fully understood. That reality was at the center of the recent webinar, “Prevent Advanced Therapy Program Delays with Early Supply Chain Strategy,” where panelists discussed how early decisions around logistics, cryopreservation, packaging, site readiness, documentation, and cross-functional alignment can influence everything downstream.

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Expand Trial Footprints Without Expanding Cryopreservation Risk

For many cell therapy programs, the move from fresh to frozen starting material is treated as the moment when variability starts to come under control. And in many ways, that’s true. Fresh leukapheresis-derived starting material is inherently difficult to build around. It is biologically active, time-sensitive, and highly dependent on how quickly and consistently it can move from collection into the next step of the process. Even under strong operational oversight, additional variables around timing, handling, transport duration, pre-processing wait time, and local execution can all influence the condition of the material before manufacturing ever begins.

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“Regulatory Readiness is Built Early” and Other Lessons for CGT Developers

Advanced therapy developers are used to making hard decisions under pressure. In early development, the priority is often clear: reach the clinic, generate meaningful data, and keep the program moving. This was the central theme of the recent webinar, “Prevent Advanced Therapy Program Delays with Early Supply Chain Strategy.” The expert panel explored why early supply chain decisions deserve strategic attention long before a program reaches pivotal trials or filing preparation.

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Now Available On Demand: Preventing Advanced Therapy Program Delays with Early Supply Chain Strategy

Advanced therapy programs move through development under intense pressure. Teams are working to reach the clinic, generate data, satisfy regulatory expectations, scale operations, and ultimately deliver therapies to patients who may have limited or no other options. In that environment of competing priorities, all of which are important at the same time, supply chain decisions can become easy to defer. But as a recent roundtable webinar with XTalks made clear, decisions around cryopreservation, logistics, packaging qualification, site readiness, and documentation are not just operational details that can be solved later.

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New eBook: Flexible Infrastructure for Smarter Scale in Advanced Therapies

Advanced therapy developers are being asked to do more with less. Programs need to move faster, reach more patients, support more geographies, and stay ready for evolving regulatory expectations, all while capital remains tightly managed. Cryoport Systems’ new eBook, Flexible Infrastructure: Minimizing CapEx for Smarter Scale in Advanced Therapies, explores that question across the advanced therapy lifecycle. The eBook looks at how developers can preserve capital, reduce operational risk, and avoid overbuilding fixed infrastructure before their programs are ready to use it. 

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Accelerate Efficiency by Decoupling Collection from Manufacturing

For many cell therapy programs, there comes a point where the manufacturing schedule stops behaving like a schedule and starts behaving more like a coordinated hold on capacity, something that can only really be maximized when collection, clinic coordination, material movement, intake, and suite readiness all happen to line up tightly enough around fresh leukapheresis-derived starting material to keep the window intact.

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How Operational Efficiency Shapes Late-Phase Manufacturability

For many advanced therapy programs, there’s a moment when the program looks like it should be able to scale cleanly, and it just... doesn’t. Not in an obvious way that can be recognized and addressed in the moment, but in the introduction of small measures of friction when the schedule doesn’t align the way it was intended to, or where time is introduced in places where it shouldn’t be.

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