For CGT developers from clinical to commercial, establishing and tracking Chain of Identity and Chain of Custody is critical to ensuring therapies are provided safely and promptly and that data is secure, auditable and in a reportable format.
Achieving this at trial phase reduces costs and errors, ensuring materials are in the right place at the right time and that quality and efficacy are not impacted by supply chain issues. However, cell orchestration has historically been inaccessible to early phase developers due to cost, time to deploy and the need to have defined supply chain processes.
OCELLOS Lite has been built to address this.
Connecting the Supply Chain
Fast, simple and effective to deploy and use, OCELLOS Lite will allow scientific and medical resources to focus on the therapy’s science and patients rather than supply chain administration.
TrakCel have launched OCELLOS Lite as a solution for early clinical stage that can grow with a therapy through to commercialization. It has been designed to be cost effective at under 5% of the cost of an average early phase clinical trial and deploys in under 12 weeks.
The system has been pre-configured based on a proven CAR-T therapy process to simplify and speed up deployment without compromising functionality, security or future features.
OCELLOS Lite can seamlessly scale to OCELLOS by opening up more integrations, treatment personas and users. This means there is no need to re-train staff or re-spend resources to be ready for commercialization.
Full reporting suite
Who is OCELLOS Lite for?
OCELLOS Lite is an accessible route into cellular orchestration for therapies in early phase clinical trials or transitioning from pre-clinical to clinical.
Mapped to an autologous therapy with an apheresis based starting material supply chain (such as a CAR-T therapy). OCELLOS Lite offers complete Chain of Custody and Chain of Identity tracking from the first patient. Records are electronic so reportable and searchable to all stakeholders in real-time.
This easily auditable, electronic audit history not only helps manage the therapy as it grows but makes it simpler to demonstrate control and consistency of process at key growth points.
Fast, simple, effective
Simple integrations into couriers, manufacturers and compliant label templates ensure that your team can focus on your therapy, not logistics without compromising quality or safety.
Upon patient registration, OCELLOS Lite will calculate the optimal timeline for key milestones in the therapy journey and display these for the healthcare user who is co-ordinating treatment timetables.
OCELLOS Lite allows manufacturing users to enter schedules and availability and makes these visible to healthcare users in the scheduling process. Integrations with couriers and labelling ensure that logistics flow smoothly and efficiently.
Electronic records eliminate paper trails and keep data organised and reportable at all times and OCELLOS Lite will grow with you, when the time comes to add functionality e.g. commercialization, this can be done without having to redeploy or retrain.