The biologic market has grown expediently over the past few years, driven not only by the pandemic but also by the increasing demand for innovative therapies, the continued rise in chronic disease areas such as oncology and the loss of patent exclusivity of leading biologic drugs.
This has led to a rapid growth of aseptic processing which is expected to reach $24.36 billion by 2031, growing from $10.63 billion in 2020, witnessing a CAGR of 7.9% (2021–2031)1
With the pharmaceutical industry’s growing pipeline of biologics, the need for technically advanced manufacturing and specialised packaging support has grown considerably. Global contract development and manufacturing organisations (CDMOs) such as PCI Pharma Services are playing a vital role, stepping in to fulfil industry needs, providing the expert capabilities and scalable capacities for the development, manufacture, packaging and supply of these life-changing drug products for patients.
Acquire, Invest, Grow
In response to the evolving industry landscape and as part of PCI Pharma Services’ global strategy to increase our sterile fill-finish capabilities and help alleviate the worldwide capacity shortage for sterile drug manufacturing and packaging, we continue to invest and grow our service offering through acquisition and investment in state-of-the-art technology and our people.In December 2021, PCI Pharma Services acquired Lyophilization Services of New England (LSNE), a premier CDMO headquartered in Bedford, New Hampshire. The acquisition was a key step for PCI, as LSNE expanded the breadth of our services as a global CDMO, building on our expertise in specialty manufacturing, clinical trial supply, and pharmaceutical packaging. PCI now offers integrated large and small-molecule solutions for our clinical and commercial clients, including global manufacturing capabilities in complex formulations, high potency, sterile fill-finish, and lyophilization.
Lyophilization is a common commercially validated process used to address formulation stability challenges and reduce the complexity associated with cold chain logistics for biologics. The use of lyophilization for pharmaceutical drug products has grown over recent years with demand for this process due to increase as more biosimiliars and novel biologics are developed.
Meeting this growing demand, PCI Pharma Services has doubled our large-scale lyophilization capacity at our Madison, Wisconsin facility providing a seamless solution to help our clients progress their drug products through the clinical cycle to commercialization and product launch.
Further enhancing our integrated development to commercialization sterile fill-finish offering, we have committed to over $100 million investment at our Bedford, New Hampshire campus. This investment will see new facilities, capabilities and increased capacity all using state-of-the-art isolator technology including high-speed, large-volume sterile fill-finish lines.
Aseptic Filling
Administered parenterally to patients, products such as vaccines and other biologics, require specific and unique production processes to optimise both particulate and bioburden control whilst ensuring uncompromised sterility throughout the manufacturing process to maximise patient safety. This has led to the development of aseptic transfer and containment methods to protect drug products from contamination for clinical and commercial scale sterile injectable products.
As a result, the industry is looking for advanced ways of improving efficiency, reducing cost and increasing sterility assurance, with robotic processing 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, and PCI Pharma Services is leading the way by investing in this cutting-edge technology to further enhance our global sterile fill-finish operations.
Robotic Aseptic Platforms at PCI Pharma Services
Complementing our global sterile fill-finish and lyophilization manufacturing capabilities across North America and Europe, PCI Pharma Services has invested significantly in state-of-the-art robotic technology platforms at both our San Diego, US and Melbourne, Australia facilities. These technologies are positioned at locations where a high volume of early phase clinical trials take place and also allow our clients to benefit from the 43% tax rebate incentive for clinical trials conducted in Australia.
Utilising the latest advancements of the Microcell and SA25 technologies, we deliver flexible aseptic fill-finish solutions for both small and larger-scale production runs across a variety of dosage forms including vials, prefilled syringes and cartridges for use in auto injectors, helping to meet our clients’ needs delivering products to patients safely and efficiently. Our investment in multiple robotic technologies provides a scalable solution for our clients, meeting requirements from smaller Phase I trials through to commercialisation and beyond.
The Microcell platforms in San Diego and Australia offer fully automated, gloveless filling, performed through closed robotic isolator technology that provides both small batch flexibility and standardised manufacturing. The fast changeover and agility of the technologies make it suitable for the production of both personalised medicine batches and 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 large-scale batch production of up to 20,000 units, supporting fill volumes from 0.2– 50mL. It provides flexible and standardized manufacturing, and the ability to fill multiple delivery device formats including vials, syringes and cartridges through an aseptic process.
For both the 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. They are also compatible with ready-to-use (RTU) containers and closures, removing the container and closure preparation stage, aiding speed of delivery of a quality and sterility-assured drug product.
Robotic Advantages for Our Clients Speed and Accuracy
Expediting the filling process with automation while also increasing accuracy, the robotic platforms with high-precision Dynamic Peristaltic Pumps ensure accurate fill volumes with minimal product losses. 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 therefore reduces cost, but ensures our clients clinical supply needs are met and key milestones are achieved as the product progresses towards commercialization.
Quality Assurance and Sterility
With a robot performing the processes in a recipe-driven, validated system and utilizing single-use parts, pre-sterilized flow paths, and ready-to-use (RTU) containers, multiple sources of risk are eliminated including; cross-contamination, human error, electromechanical 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 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 our clients are able to move more rapidly through the clinical stages and provide safe, life-changing therapies to patients.
Flexibility
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 us to better support clients who have urgent drug product supply needs.
Seamless Sterile Solutions
Our clients have the aim of accelerating their sterile drug development lifecycle and seek readily available capacity, reducing time to clinic and ultimately commercial launch. They seek experienced partners able to meet their fill demands with state-of-the-art technology to minimize the risk of failure, particularly in the early-stage development of complex, high-value products that by nature can be difficult to handle. Any failure during the aseptic fill-finish process can lead to product degradation affecting a drug’s efficacy and safety. The importance of mitigating risk cannot be overstated: failure in a batch can mean significant time to replace it at substantial cost and may put the entire timeline in jeopardy, delaying clinical trials, launch plans, and commercialization and ultimately impacting patient lives.
The addition of these innovative robotic aseptic fill-finish platforms in our San Diego and Australian facilities enhances our renowned sterile and lyophilization capabilities across our global network. These advanced technologies not only expedite the filling process with automation but being able to pivot between filling different sterile medications into multiple dosage formats, brings even broader sterile fill-finish solutions to PCI clients across the entire drug product lifecycle bringing therapies to market with increased speed and safety.
Providing integrated end-to-end solutions and helping to reduce supply chain complexity and risk, our clients can also access our expert secondary packaging, labeling and distribution solutions available across our extensive global network, leveraging the benefits of with working with a single supplier. Combining our expertise in sterile fill-finish manufacturing with specialist biologic packaging, labeling, and cold chain distribution provides a valuable end-to-end solution, simplifying the supply chain while delivering time and cost efficiencies.
Future Outlook
As more new biologically derived therapies such as antibody, mRNA, and SRNA treatments are discovered, the need for specialized sterile fill-finish capabilities and capacities will continue to increase. And, as the biopharmaceutical industry seeks to reduce the time to market for new therapies and lower the risk associated with high-cost product loss whilst increasing sterility and patient safety, robotic platforms will be a true differentiator, offering an additional level of assurance and delivering products to clinic as rapidly as possible without compromising drug product quality or patient safety.
Robotic Aseptic Processing. – seen in International Pharmaceutical Industry Journal – October 2022
REFERENCES
1. Aseptic Pharma Processing Market – Industry Analysis, Trends & Forecast 2031 | BIS Research
We are committed to supporting clients at every stage of the manufacturing cycle, delivering best-in-class services efficiently and effectively.
Find out more about our fully integrated CDMO Services.