Meeting accelerated early-phase clinical timelines for small and emerging biopharma 

Today, small and emerging biopharmaceutical companies are overwhelmingly driving innovation.  In 2022, emerging biopharma companies were responsible for two-thirds (4,500) of the molecules in the global R&D pipeline, and in the same year originated 67% of all new US drug approvals and launched 69% of those, indicating more independence on the part of these companies in taking their drug products from innovation to market. 1

With innovative therapies transforming the lives of patients around the world every day, biopharmaceutical companies are challenged to develop and deliver these products in a dynamic, ever-changing market. This coupled with inflationary market conditions and funding pressures, means that speed to patient and efficiency are more critical than ever.

New technologies and processes are helping to address these needs, by accelerating sterile manufacturing while improving efficiency, reducing costs, and increasing drug product quality all while delivering sterility assurance.  For these reasons, robotic processing is gaining huge popularity for the primary filling of Ready to Use (RTU) containers. Robotic aseptic fill-finish technology and the use of isolator-barrier systems are emerging as vital capabilities to supply life-changing therapies to patients as quickly and efficiently as possible.

Addressing this need, PCI Pharma Services has expanded our global sterile fill-finish capabilities with the addition of three new robotic gloveless isolator sterile filling technologies.  This investment includes one Cytiva Microcell platform located at our Melbourne, Australia facility and a second Cytiva Microcell located at our San Diego, US facility which is further complemented by a larger scale Cytiva SA25 platform co-located at the same site.   

Utilizing the latest advancements of robotic sterile filling technologies, these investments provide flexible aseptic fill-finish solutions for both small and large-scale clinical production runs across a variety of dosage forms including vials, syringes and cartridges for use in autoinjectors, addressing our clients’ scalable aseptic manufacturing needs from preclinical, through First in Human (FIH) trials and beyond, delivering products to patients safely and efficiently.

The Microcell platforms located at our San Diego and Melbourne facilities offer fully automated, gloveless filling, performed through closed robotic isolator technology that provide both small batch flexibility and standardized manufacturing. The agility of these technologies makes it suitable for the production of both personalized medicine batches, preclinical and early phase clinical trial supplies delivering true speed to patients. Superior drug product quality is assured through advanced automation, removing the need for operator intervention during the filling process and limiting product contact. Importantly, the Microcell technology can fill up to 1,200 units per batch with fill volumes ranging from 1.0–50mL.

Providing a scalable aseptic solution in support of clients progressing through the clinical lifecycle towards commercialization, the SA25 Aseptic Filling Workstation is a larger-scale, gloveless, isolator-based filling technology offering small and larger-scale batch production of up to 20,000 units, supporting fill volumes from 0.2 – 50mL. This technology provides flexible manufacturing solutions with the ability to fill multiple delivery device formats including vials, syringes and cartridges through the aseptic process.

For both the Cytiva Microcell and SA25 technologies, precise, programmable robotic functions cover all aspects of the fill process, including isolator leakage tests, VHP sterilization of the container closures, filling into the CCS of choice, capping and batch delivery. Importantly, they are also compatible with RTU containers and closures, removing the container and closure preparation stage, aiding speed of delivery of a quality and sterility-assured drug product.


Client CDMO Case Study: Meeting Accelerated Early Phase Clinical Timelines

Meeting accelerated early phase clinical timelines for small and emerging biopharma | International Clinical Trials, November 2023, pages 64-65. Samedan Ltd

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