Cell and gene therapy (CGT) manufacturing

Supply chain software for personalized therapies

Cell therapy and gene therapy manufacturing teams transform the most fragile of raw materials — living cells — into powerful, personalized therapeutics. Manufacturing batches can be as small as one dose per patient, and yet they rely on production processes that must be able to quickly scale up to serve large numbers of potential  patients. Few pursuits in biopharmaceutical manufacturing are as rewarding — or as complex.

Vineti’s CGT manufacturing software simplifies and streamlines the production process for cell therapies, gene therapies, and personalized cancer vaccines.

Manufacturing Facility

Challenges and solutions

Cell and gene therapies can be extremely difficult to manufacture, requiring precision amid a complex and often unpredictable process. Multiple stakeholders necessitate ongoing orchestration, including participants who are collecting starting material but may have never participated in GMP processes before. And everyone is focused on manufacturing timelines, so that patients can receive their personalized treatment as quickly as possible. 

Vineti’s Personalized Therapy Management (PTM)® platform has supported dozens of teams focused on cell and gene therapy manufacturing  operations, materials management, and manufacturing quality. PTM® is a software solution that supports cell therapy manufacturing, helps manufacturing experts optimize their capacity and resources, automates compliance, scales key cell therapy production processes, and makes more transformative products for more patients, on time and on track.

  1. 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.

  2. 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.

  3. 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

  4. 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

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

    Solution: End-to-end traceability and product tracking

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

“My manufacturing extends out in many directions, and I need one place where I can see it all and manage it all — what’s coming in, what’s in process, what’s final product, and what’s shipping out for infusion. Manufacturing for cell therapies is multi-dimensional, and it never stops moving. I need a quality-centered system that lets me handle everything, from a master view of every batch down to a single product for one patient.”

Manufacturing lead, late-stage autologous cell therapy company

Master your cell and gene therapy manufacturing with PTM®

If you focus on cell therapy or gene therapy Manufacturing Operations, PTM® provides end-to-end control with:

  • Real-time, multi-party capacity management that enables more efficient planning, product journey management, and manufacturing.
  • On-demand cloud label printing — on any hardware — with built-in change management.
  • Configurable workflows that reflect your SOPs and capture accurate data — including COI and COC — from collection to infusion.
  • Efficient, user-friendly communication with all ecosystem stakeholders, including clinical sites
Researchers looking at a vial

If you focus on cell therapy or gene therapy Materials Management, PTM® delivers a master view of all the moving parts with:

  • Real-time digital status of inbound starting materials
  • Digital pre-manufacturing documentation.
  • Automated support for material receipt, storage, disposition, and shipping.
  • Automated linkages between lot numbers and Chain of Identity.
  • Digital courier scheduling, including tracking and change management.
Researchers looking at a vial

If you focus on cell therapy or gene therapy Manufacturing Quality, PTM® streamlines record-keeping and compliance with:

  • Automated, industry-leading Chain of Identity and Chain of Custody.
  • Automated, on-demand, real-time reporting, including COI and COC.
  • Digital tracking and recording of patient data, key milestones, and decision criteria to support batch record review.
  • Cloud-based label review and change management.

Learn more about how Vineti’s PTM® supports Quality teams at every step in the cell and gene therapy production process

Researchers looking at a vial

Vineti’s configurable platform for Manufacturing ease

Get a glimpse! Vineti’s configurable platform facilitates end-to-end traceability and product tracking, including the manufacturing process. This allows customers to record lot numbers to automatically link them with the Chain of Identity, provides product receipt, storage and disposition at the manufacturing facility, and logs manufacturing milestones, to provide visibility into manufacturing progress. Our Personalized Therapy Management (PTM) platform is the essential solution for speed, safety, and scale. Get in touch with us today to learn more!

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See the PTM® manufacturing solution in action

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Whether you are handling manufacturing for early clinical trials or for commercial scale, Vineti is here to help.

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