Company insight Cutting edge D
riven not only by the pandemic but also by the increasing demand for innovative therapies and the continued rise in chronic disease areas such as oncology, the biologics market has grown exponentially over the past few years. As a result, there has been a rapid growth of aseptic processing that is expected to reach $24.36 billion by 2031, growing from $10.63 billion in 2020, witnessing a CAGR of 7.9% (2021–2031). Administered parenterally to patients, vaccines and other biologics require specific production processes to optimise both particulate and bioburden control whilst ensuring uncompromised sterility throughout the manufacturing process to maximise patient safety and to reduce risks of any adverse complications resulting from contamination. Protecting drug products from contamination has led to the development of aseptic transfer and containment methods for clinical and commercial sterile injectable products. Through looking for advanced ways of improving efficiency, reducing cost and increasing sterility assurance, robotic processing has been gradually gaining huge popularity for the primary filling of Ready to Use (RTU) containers such as vials, syringes and cartridges. Robotic aseptic fill-finish technology and the use of isolator-barrier systems are emerging as key to keeping pace with these requirements.
Complementing PCI Pharma Services sterile fill-finish and lyophilisation capabilities across North America and Europe, PCI has invested significantly in state-of-the-art robotic technology platforms at both our San Diego, US and Melbourne, Australia facilities. Utilising the latest advancements of the Microcell and SA25 technologies, the
fill-finish solutions
Utilising the latest advancements of the Microcell and SA25 technologies, PCI Pharma Services delivers flexible aseptic fill-finish solutions for both small and larger-scale production runs across a variety of dosage forms, helping to meet clients’ scalable aseptic manufacturing needs, delivering products to patients safely and efficiently.
company delivers flexible aseptic fill- finish solutions for both small and larger- scale production runs across a variety of dosage forms including vials, pre-filled syringes and cartridges for use in auto injectors, helping to meet our clients’ scalable aseptic manufacturing needs, delivering products to patients safely and efficiently.
Advantages of robotic processing There are several advantages to robotic processing that includes, among other benefits, sheer speed and accuracy. Expediting the filling process with automation while increasing accuracy, robotic platforms with high-precision Dynamic Peristaltic Pumps ensure accurate fill volumes with minimal product losses during the manufacturing process. This is a significant benefit to our clients, who are often developing life-changing, high-value drug products with the need of progressing through the clinical pipeline with efficiency and speed. Minimising product losses not only conserves valuable drug product and reduces cost, but ensures clinical supply needs are met and key milestones are achieved as the product progresses towards commercialisation. With a robot performing the processes in a recipe driven, validated system and utilising single-use parts, pre-sterilised flow paths and RTU containers, multiple sources of risk are eliminated including: cross-contamination, human error, electro-mechanical filling and closure activity failures, environmental control failures, cleaning and set-up errors, and product loss.
Using press-fit vial closures with integrated rubber stoppers not only reduces the risk of particle contamination
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but also simplifies the manufacturing process with the press-fit closures being a one-step application that presses closures on top of the vials, versus the traditional two-step process of stoppering and aluminium crimp capping. All this combined means clients are able to move more rapidly through the clinical stages and provide safe, life-changing therapies to patients.
Robotic technologies are designed for maximum flexibility while maintaining high aseptic processing rates. Meeting the needs to fill many different products and process multiple projects with minimal changeover time between batches, provides ultimate savings in time allowing PCI to better support clients who have urgent drug product supply needs.
Seamless sterile solutions The addition of these innovative robotic aseptic fill-finish platforms at our San Diego and Australian facilities enhances our renowned global sterile and lyophilisation capabilities. These advanced technologies not only expedite the filling process with automation but being able to pivot between filling multiple dosage formats, brings even broader sterile fill-finish solutions to PCI clients across the entire drug product life cycle bringing therapies to market with increased speed and safety. Combining our expertise in aseptic manufacturing with specialist biologic packaging, labelling and cold chain distribution provides a valuable end-to- end solution, simplifying the supply chain while delivering time and cost efficiencies for our client partners. ●
www.pci.com 23
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