Flexible supply chain orchestration – TrakCel and BINOCS announce a partnership to support scalability and scheduling requirements for Cell & Gene Therapy (CGT) products

Flexible supply chain orchestration – TrakCel and BINOCS announce a partnership to support scalability and scheduling requirements for Cell & Gene Therapy (CGT) products 

With a number of mutual clients in the CGT industry, the companies are integrating BINOCS and OCELLOS, their respective Software as a Service (SaaS) solutions, to offer therapy developers even more control and visibility over their manufacture and supply processes. BINOCS will support them in managing and scheduling their workforce, equipment, clean rooms and specific business rules across production and QC teams. Meanwhile, TrakCel will implement OCELLOS to track and report client Chain of Identity (CoI) and Chain of Custody (CoC), critical measures for ensuring patient safety and in supporting the volatile CGT supply chain.

Despite their exceptional therapeutic and curative nature, CGT products are prescribed at a very fragile point in a patient’s treatment. Ensuring that each patient receives their drug product in a predictable and timely fashion is critical for patients and their families. Exceeding patient and caregiver expectations should be the baseline operational goal set by companies and manufacturers delivering these therapies.

• Starting materials (apheresis, bone marrow or tumor biopsy) should be collected in a way that is both convenient for the patient and adheres to pre-agreed schedules
• No patient should be expected to return for another collection (unless necessary) due to inadequate manufacturing capacity or logistical errors
• Health Care Providers (HCPs) are busy, especially in the recent turbulent times, so minimizing disruptions to their schedules is also essential. Providing visibility on the most feasible starting material collection (in line with manufacturing capacity) is key to providing high customer satisfaction and service standards

As more therapies progress from clinical studies to commercial products, the number of available treatments and treated patients will continue to increase and so supply chains will become more complex. BINOCS and TrakCel are delivering an integrated solution that will address the current challenges in scaling-up supply chain and manufacturing operations.

“This partnership with TrakCel showcases our vision of becoming the standard for scheduling and operational management in this fast-growing industry. BINOCS is already supporting QC operations for commercial CGT products, and we have further expanded our offering to include production scheduling and planning,” said Geert Vanhove, Executive Vice President of BINOCS. “Integrating with TrakCel will enable us to further expand our value and footprint in supporting CGT products and associated supply chains. BINOCS’ unique zero-code interfacing enables us to integrate with other systems seamlessly and we have successfully delivered multiple integrations with third-party providers like LIMS and ERP systems. We aim to deliver an ecosystem with TrakCel and others that offer great value to our clients and ultimately the patients and caregivers.”

“OCELLOS is the most advanced CGT Orchestration software yet being built on the Salesforce.com platform with MuleSoft connectivity,” Dr Fiona Withey, CEO, TrakCel commented. “We recognise the value that connecting OCELLOS with solutions like BINOCS offers customers real-time information about each patient’s treatment at their fingertips enabling even more visibility and greater control.”

About BINOCS

BINOCS is a leader in scheduling and capacity management created by Bluecrux Inc. Bluecrux is a rapidly growing solution provider for value chains headquartered in Belgium, with offices in New Jersey, Ireland and Netherlands. BINOCS was created in 2015 and has since become a market leader in supporting QC, Research & Development and Process Development operations across the world. The solution has been adopted by many major pharmaceutical, CRO, contract laboratory and biotechnology companies.

About TrakCel

TrakCel is the leading innovator of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel's software platform, OCELLOS, has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The OCELLOS TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining treatment collection to administration compliance and traceability. TrakCel is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey.