Cell Therapy Clinical Trials

Distributed, complex supply chains built around patients and donors can be extremely difficult to view, track, and manage.

Solution: A proven, configurable platform that gets your manufacturing up and running sooner and keeps your end-to-end times on track.

Quality requirements are rigorous, including those related to Chain of Custody and Chain of Identity.

Solution: Flexible, compliant cloud-based label printing on any hardware.

Manufacturing batches are small — often as small as one per patient.

Solution: “Smart scheduling” to optimize manufacturing slots and shipping from clinical sites, labs, manufacturing facilities, and storage centers worldwide, allowing a higher volume of order fulfillment

A novel manufacturing paradigm means that the cell therapy production process extends beyond the traditional factory and into hospitals and healthcare settings not covered by Good Manufacturing Practices (GMP) guidance.

Solution: Industry-leading digital Chain of Identity and Chain of Custody, with digital workflows that walk stakeholders through GMP processes step by step and capture required data and signatures

Traceability is essential end to end, yet difficult to maintain across a distributed ecosystem.

Solution: End-to-end traceability and product tracking

Manufacturing capacity is often limited and must be orchestrated in real-time to take advantage of every available slot.

Solution: Best-in-class, user-friendly capacity management — set up your manufacturing capacity and allow your stakeholders to book slots, arrange shipments, and make the process work for them and for you.

The supply chain can be highly variable and unpredictable, with non-stop volatility complicating everything from raw material collection, to shipping, to manufacturing suite usage.

Solution: Automated dashboards give visibility into the status of entire product lines or individual product journeys. Best-in-class change management tools, steeped in real-world experience. Need to reroute a batch to a different facility, print a revised label, or reschedule a shipment? With PTM®, it’s no problem.

Manufacturing processes can be complex and require a high degree of precision and compliance.

Solution: Automated regulatory compliance. Patient- and collection-related documents, such as those related to starting material, that are readily available any time via a cloud-based digital system.

Data management is of vital importance: large amounts of data must be documented, collected, and reported for each batch. Chemistry, Manufacturing, and Controls (CMC) data takes on greatly increased importance in cell and gene therapy approvals, and gaps or errors have the potential to trigger extensive regulatory delays.

Solution: Proven data management, ranging from per-patient data to process-wide analytics and enabling a robust, auditable CMC package.

Fast scale-ups are expected: beyond the earliest stages of a clinical trial, manufacturing experts are asked to quickly scale up production processes that may have been developed for just a few patients.

Solution: Built-in standards and best practices help streamline the transition to greater scale, and configurability that lets you create a version of PTM® that supports your product.

Manufacturing costs can be high, and every additional complexity makes these costs harder to control. Manufacturing teams are asked to bring breakthrough science to life while keeping a rigorous eye on the bottom line.

Solution: A more cost-effective way to manage the distributed resources so often found in cell and gene therapies, where manufacturing can be done in-house, via satellite or contract facilities, or through a mix of all these options.