Autolomous will combine its manufacturing management systems with Vineti’s Personalized Therapy Management (PTM) platform to form an end-to-end cell and gene therapy pathway.
The partnership between Autolomous and Vineti, two technology solution providers for cell and gene therapy (CGT) supply chains, aims to drive the visibility and exchange of information between stakeholders across the CGT value chain to ensure the companies can respond to unpredictable variables that occur with biological processes.
According to Autolomous, the integration of the technologies will drive scale-up of production by upping compliance, auditability, and transparency while also delivering savings in time and resources.
“Vineti will manage the front end in terms of the collection of the starting material at clinical centers and then they [will] maintain the chain of identity. They also manage the back end and deliver the drug product back to the hospital for infusion.” Kwok Pang chief operating officer at Autolomous told BioProcess Insider.
“Autolomous [is responsible] for the bit in the middle. We manage everything that happens at the manufacturing facility, from the point that the patient’s blood enters the front door to all the different steps and all the different actors that need to get involved in between manufacturing so that we have a certified drug product that exits the back door and then forwards on to fusion. It is a partnership that provides the CGT developer making this product visibility across the whole value chain.”
According to Autolomous, the supply chains will become “more complex” as the amount of available therapies and treated individuals continues to rise. Vineti has developed its Chain of Identity (CoI) and Chain of Custody (CoC) systems to maintain visibility and security of the value and supply chains throughout.
Additionally, Autolomous’ manufacturing focused platform will be united with a Cell Orchestration Platform (COP), to provide support across the entire CGT value chain.
“The traceability across the whole space needs to be exact, we must deliver the same starting product from the patient, back to the same patient,” said Pang.
“The challenge of autologous manufacturing is that it’s a scale out as opposed to scale up. We are running supply chains that have one value chain for every patient […] so the way that we provide that security is with digital systems. We track, and we know exactly the movements of each product in that one large room.”
The first stage of the integration will include implementation of Vineti’s notifications API, which will allow users of Autolomous’ AutoloMATE service platform to action orders once they are created and throughout the development of the order.
Once the first stage is complete, both firms will establish a technical proof of concept in the third quarter of 2021 and apply this integration with an existing customer of both organizations in 2022.
“Vineti is one of those types of partnerships that we believe adds a lot of value and we’re looking for further partnerships [with] others do the same thing,” Pang said.