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PCI Pharma Services – Robotic Aseptic Processing

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 the 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.

PCI Pharma Services – 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 speciality 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 biosimilars 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 commercialisation and product launch.

Further enhancing our integrated development to commercialisation 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.