Autolomous and Vineti formed a non-exclusive collaborative partnership that will integrate Autolomous’ manufacturing management systems with Vineti’s Personalized Therapy Management® (PTM) platform. The goal is to enable both parties to create a seamless end-to-end cell and gene therapy (CGT) delivery pathway, including critical inbound and outbound manufacturing value processes.
The partners are seeking an increase in the visibility and dynamic exchange of information to and from stakeholders across the cell and gene therapy value chain to ensure they can react to unpredictable variables related to working on biological processes. Furthermore, the integration of the technologies will enable scaling up of manufacturing by increasing transparency, compliance, and auditability while delivering significant savings in time and resources from efficiency gains, according to an Autolomous spokesperson.
Vineti has developed its Chain of Identity (CoI) and Chain of Custody (CoC) systems to be vital elements of the cell and gene therapy value-chain, says Amy DuRoss, CEO and co-founder, Vineti, adding that the critical nature of these systems specifically within this sector is because visibility and security of value and supply chains must be maintained throughout, from the procurement of patient material to the delivery of drug products. These supply chains are expected to become more complex as the number of available therapies and treated patients continues to increase.
This will be the first time Autolomous’ manufacturing focused platform will be integrated with a Cell Orchestration Platform (COP), which is an integral part of Autolomous’ long-term strategy to provide support across the entire CGT value chain, explains Alexander Seyf, CEO and co-founder, Autolomous. This collaboration follows the receipt by Autolomous and partners of a joint GBP 1 million project grant from UK Research and Innovation (UKRI) to enhance the scheduling and manufacturing of advanced therapies within the U.K.’s NHS, for the U.K.’s Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC).
As part of the project Autolomous will provide a demonstration of an electronic Batch Manufacturing Record (eBMR) solution integrating with a dedicated NHS advanced therapies ordering system. It also follows Autolomous’ receipt of a loan from UK Research and Innovation (UKRI) to expedite development of AutoloMATE-Assist, its digital batch verification technology for cell and gene therapies. Once completed, Autolomous will take this U.K. healthcare provision model and expand this to the US and other major national healthcare networks globally, continues Seyf.
First stage of integration
The first stage of the integration between Autolomous and Vineti will be a live implementation of Vineti’s notifications API. This implementation will enable users of Autolomous’ AutoloMATE service platform to action orders as soon as they are created and throughout the entire lifecycle of the order. The integration should allow manufacturing teams to optimize the manufacturing capacity. Unplanned and unexpected changes within the supply chain, such as cancellations, rescheduling, and manufacturing delays will be communicated across technology and systems from Autolomous and Vineti.
Once this first stage is completed, Autolomous and Vineti plan to demonstrate a technical proof-of-concept in Q3 2021 and implement this integration with an existing customer of both organizations in 2022.
“Autolomous is now building strategic value-add collaborations across the cell and gene therapy industry to provide solutions to critical needs within value chains. This will result in a holistic platform that specifically targets critical ecosystem partners, including healthcare providers, such as the U.K.’s NHS, personalized therapy management platform providers including Vineti and those involved in the manufacturing component of supply chains, such as Autolomous,” says Seyf.
“We have selected to collaborate with Vineti to provide a unified single digital solution that can be used from the collection of patient starting material, manufacturing, through to the delivery of therapies. The seamless integration between Autolomous’ and Vineti’s solutions will ensure scalability when cell and gene therapies become standard of care, and involve a plethora of supply chain partners and patient samples.”
“Partnering with Autolomous will allow Vineti to expand its provision across the CGT value chain. The integration of both organization’s technologies will give Vineti additional tools to satisfy the rising procurement and delivery demands of the CGT sector,” notes DuRoss.