A European virtual biotech company approached PCI Pharma Services seeking integrated drug development, manufacturing, packaging and distribution support to progress their innovative siRNA based injectable therapy from preclinical studies to FIH clinical trials. After securing their drug substance supply, the client company had aggressive clinical timelines and needed an end-to-end clinical drug product development and packaging solution to ensure their lead drug candidate was available for phase 1 trials within a 5 month timeframe.
Process and Solution
The client required a global CDMO with expertise in sterile development and manufacturing, packaging and cold chain distribution of fragile large-molecule formulas. The CDMO needed to be a responsive outsourcing partner with strong formulation development know-how and with available sterile filling capacity who could provide a tailored, scalable solution.
Although the initial project requirement was ultra-low volume batch requirements (150 vials) the partnering CDMO needed to be able to support the client’s journey through the clinical lifecycle towards commercialization. With limited internal resources, the client company preferred a streamlined supply chain with single point of contact for ease of project management and communication.
PCI’s Speed to Study™ proposition of sterile filling, clinical packaging and distribution all provided from our San Diego, US facility was the ideal solution for the client. Our innovative advanced robotic gloveless isolator aseptic vial filling platform has the capability to de-risk the filling step of their valuable product (no human intervention) and more importantly for the client, the instant capacity access to fill their siRNA therapy into small batches of vials using readily available component stock.
Upon being appointed as the clients preferred partner for their lead clinical drug product, the PCI San Diego leadership team brought together a multi-disciplinary project team of experts from sterile development, manufacturing, clinical packaging operations and distribution. The Project Manager developed a fast tracked project and communication plan with key milestones throughout the 5 month period and was the clients’ single point of contact for all operational deliverables.
The Cytiva Microcell Vial Filler used for this early phase clinical project provided small batch flexibility with closed robotic isolator technology. With multiple sources of risk eliminated through single use parts, pre-sterilized flow paths, ready to use containers and no human intervention, an enhanced quality and sterility assured drug product for FIH dosing was delivered.
Providing a truly integrated, end-to-end solution, streamlining the supply chain, mitigating risk and reducing timelines, the onsite PCI clinical packaging team labeled and packed the vials for shipment to clinical sites in ample time of the initiation of the clients phase 1 trial.
At PCI, together with providing flexible scalable solutions, delivering best-in-class services efficiently and effectively, we are committed to meeting the dynamic needs of our client’s clinical journey. We immerse ourselves in every client project, working in partnership to provide collaborative, creative and tailored approaches to deliver upon our mission of being the bridge between life-changing therapies and patients.