PCI Pharma Services: Enhanced Sterility Assurance with Robotic Aseptic Processing

Driven 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 biologic market has grown expediently over the past few years.  As a result, there has been 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

Aseptic Filling

Administered parenterally to patients, vaccines and other biologics require specific production processes to optimize both particulate and bioburden control whilst ensuring uncompromised sterility throughout the manufacturing process to maximize patient safety.  Protecting drug products from contamination has led to the development of aseptic transfer and containment methods for clinical and commercial sterile injectable products. 

Looking for advanced ways of improving efficiency, reducing cost and increasing sterility assurance, robotic processing is 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 sterile fill-finish and lyophilization 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. 

Utilizing 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’ scalable aseptic manufacturing needs, delivering products to patients safely and efficiently. 

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 standardized manufacturing. The fast changeover and agility of the technologies make it suitable for the production of both personalized 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.

Advantages of Robotic Processing

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.  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.  Minimizing 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 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 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 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.

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 PCI 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, commercialization and ultimately impacting patient lives.

The addition of these innovative robotic aseptic fill-finish platforms at our San Diego and Australian facilities enhances our renowned global sterile and lyophilization 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 lifecycle bringing therapies to market with increased speed and safety. 

Combining our expertise in aseptic manufacturing with specialist biologic packaging, labeling and cold chain distribution provides a valuable integrated end-to-end solution, simplifying the supply chain while delivering time and cost efficiencies for our client partners.

As the industry seeks to reduce 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.

Author: Tom McGrath, VP Global Quality, Manufacturing, PCI Pharma Services

Tom McGrath is currently the VP, Global Quality, Manufacturing at PCI Pharma Services, an integrated global CDMO.  Mr. McGrath has over 25 years of in drug development, quality, and regulatory roles, with the last decade or more focused on aseptically processed pharmaceuticals and medical devices. Prior to assuming his current role in 2014, he was Sr. Director of Quality for Aseptic Services at AMRI–Burlington (now Curia), where he led successful remediation efforts. Before that he held development and quality positions of increasing responsibility at AMAG Pharmaceuticals, CombinatoRx and Praecis Pharmaceuticals. Tom received his B.A. degree in Chemistry from The College of the Holy Cross.

1 (Aseptic Pharma Processing Market - Industry Analysis, Trends & Forecast 2031 | BIS Research)