Architecture & Technical Approach
Our approach to the cell and gene therapy process
The cell and gene therapy process involves unique, patient-centric requirements that bring new levels of complexity to the biopharmaceutical industry. Older systems are not much help when it comes to orchestrating new personalized supply chains and manufacturing models. These novel, systemic challenges can’t be solved by legacy IT systems or a myriad of custom-built software for each individual biopharma company or advanced therapy product.
Instead, advanced therapies required advanced technology — the type of digital innovation pioneered by Vineti. Simplifying advanced therapies and driving adoption requires a rigorous enterprise approach, where technology learnings from other industries and advanced therapy best practices can be baked into a foundational solution that powers an entire industry and brings forth broad usage of cell and gene therapies. That’s the premise underlying Vineti’s Personalized Therapy Management® (PTM) platform — cell therapy SaaS that is purpose-built for advanced therapy supply chains, workflows, and data management.
PTM® solves for inherent complexity by bringing the best principles and practices of enterprise software to advanced therapies. PTM® is an aPaaS (Application Platform as a Service) — a purpose-built enterprise solution providing a common technological foundation that delivers standards and best practices while serving individual customer needs through configuration.
Software built for advanced therapies
Here are some of the core technology approaches that have made Vineti’s PTM® the industry leader.
A true enterprise-grade solution
PTM® is a robust, scalable system — a common cloud-based digital platform with configurable workflows.
We offer our customers and partners the ability to build the unique facets of their workflows and brand in a consistent and singular platform, without creating customized code lines. Configurability means less effort and less long-term risk than custom code, and ensures that our clients are able to scale their workflows with the needs of an evolving and complex therapy.
This platform is focused squarely on our industry, and our team has always remained singularly motivated by the unique challenges presented by personalized therapeutics.
Standards and best practices
Decades of collective industry expertise are baked into PTM®, as are the uniquely rigorous compliance and patient safety requirements of CGT, including GMP, GAMP5, HIPAA, GDPR, 21 CFR Part 11, EUDRALEX Annex 11, ISBT-128, SEC, NIST, and more.
Top-tier security and compliance features safeguard each partner’s IP and patient privacy.
Vineti’s PTM® Integration Suite seamlessly connects the CGT value chain for right-first-time patient and product journeys. Based on patient-focused use cases, this purpose-built suite of APIs is pre-configured and pre-validated to quickly and simply digitize critical workflows driven by patient data. Utilizing modern, best-in-class API technology, and built with security and privacy as a priority, PTM® APIs create an interoperable, reliable value chain that protects patient privacy and safety. Our enterprise approach to integrations connects PTM® to the CGT ecosystem — with more connectors to be added as the Vineti Alliance Network grows.
Benefits of a platform approach to cell & gene therapy software
In the emerging advanced therapy industry, innovations in workflows and data management travel alongside breakthroughs in science. Biopharmaceutical manufacturers and Healthcare Providers are often evolving their processes in real time. The only way to continuously adapt to an evolving industry is through a flexible, foundational platform.
Vineti’s PTM® platform offers a foundation that anticipates change, even as it drives growth. If an advanced therapy workflow requires seven steps, instead of three, for example, or if it goes from seven steps to six over time, PTM® can adapt. PTM® provides an “opinionated” but flexible platform that guides advanced therapy supply chain orchestration structurally, but not specifically.
The platform approach also enables simpler updates, especially when compared to custom applications. Bespoke solutions are typically built as one-time, stand-alone development projects by third-party firms that may change staff or move on after the project is complete. Companies relying on custom applications often end up with a collection of separate systems — possibly built by different developers — resulting in scattered pockets of knowledge and a mix of disparate systems to manage, update, and maintain. When it is time to make updates, the original team and their expertise may no longer be available, resulting in lost time and greater development expense. PTM® solves that problem. Everybody is on the same platform foundation, benefiting from the fact that PTM® is always improving. Vineti is always working to improve PTM® and add in the latest industry standards — learning from the best practices in the industry — for the benefit of every customer.
Learn more about data management challenges in advanced therapies, and how PTM® delivers the solution.