Cambridge, UK—TTP plc announced today that the company has partnered with Quotient Ltd, a commercial-stage diagnostics company committed to transforming transfusion diagnostics and beyond, to develop and implement a state-of-the-art manufacturing facility for Quotient’s MosaiQ system.
MosaiQ, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform which allows for multiple tests across different modalities. The instrument is designed to be a game-changing solution, which Quotient believes will increase efficiencies, improve clinical practice, and deliver significant workflow improvements and operational cost savings to laboratories worldwide.
TTP has been a development partner for MosaiQ, providing extensive technology, science and engineering input to make possible Quotient’s vision of developing a multiplexed testing platform based on a custom consumable, including a microarray and a custom instrument.
“The multi-disciplinary team at TTP are highly experienced, and were able to rapidly assist us in the manufacturing of MosaiQ to build what is now an industry leading system. Their expertise, together with their drive to bring our idea to reality, made them the ideal partner,” said Ed Farrell, president at Quotient.
TTP initially undertook a product feasibility study and carried this through to the conception and delivery of a high-volume consumable-manufacturing facility. This included the design and manufacture of a low-cost consumable, development of robust manufacturing systems and several bespoke high-volume manufacturing processes. This includes microarray printing, array processing and high-speed assembly, as well as the use of user centered design research to specify the user requirements of the processing instruments.
SureDrop, TTP’s bespoke microarray printing technology that has a unique capability to print a broad range of materials including cells, proteins, DNA and polymers, is key to the printing of microarrays for this pre-transfusion blood testing, which includes printed blood cells and antibodies. The SureDrop print module forms part of the MosaiQ system.
To facilitate Quotient’s requirements, TTP developed a custom-made print module, incorporating improvements to the technology necessary for this application. A high-volume manufacturing line, operating within its own quality management system, was established at TTP’s Melbourn Science Park headquarters, in order to ensure the successful delivery of production print modules.
“This has been an incredibly exciting partnership as Quotient’s MosaiQ platform is set to radically change the field of blood transfusion typing and screening,” added Phil Rawlins, program manager at TTP. “The unique printing capability of SureDrop is a perfect fit with this application and working with Quotient to commercialize a high-volume manufacturing system has been extremely rewarding.”
At the beginning of May, Quotient announced receipt of the Conformité Européenne (CE) Mark for its initial Immunohematology (IH) Microarray for use in transfusion diagnostics with its MosaiQ diagnostic platform, following the successful conclusion of its first EU field trial in July 2018 and the subsequent submission of the technical dossier for CE Mark approval in late September 2018.
Franz Walt, Quotient’s chief executive officer, noted that “With this critical approval, we can begin commercialization and can fully interact with customers, allowing us to demonstrate the significant benefits which MosaiQ will offer to their laboratory operations. Moving forward from a development perspective, our focus is now on menu expansion. In line with our product portfolio roadmap, the next IH microarray will move from development into field trials shortly, in conjunction with the submission of the clinical data from our ongoing initial SDS Microarray’s European field trial for CE Mark approval. Menu expansion plans also include a third-party evaluation of our novel approach to Molecular Disease Screening which we plan to complete later this year.”