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.
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.
“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
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.
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
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!