PCI Pharma Services

Chris Dobbs

At PCI, we are continuing to expand our European Biotech capabilities with a further $13.5m investment in the latest, state-of-the-art packaging technologies, complementing and mirroring recent investment in our U.S. Biotech Centre of Excellence at PCI’s Philadelphia facility. The planned European investment will enhance our capacity to process the novel drug delivery systems required for biologic products, providing our customers with end-to-end packaging solutions to meet growing market demands.

The packaging of biologics is highly complex, often requiring very specific packaging, storage and logistics solutions. An understanding of the potential risks to the product throughout the life-cycle is critical; as a result, using an expert partner able to take a product from the early stages of clinical development through a scalable process to commercial launch can be a cost-effective way of minimizing risk whilst expediting timelines.

PCI has been delivering biotech services in Europe for over 20 years and has developed a wealth of experience and expertise in managing such products. It is well recognized that worldwide forecasts for biologic drugs, including the increasing prevalence of biosimilars, has seen significant growth over the last decade, a trend set to continue over the coming years. As a result, this latest investment follows PCI’s continued strategy of investing in technology and capacity today to offer the best possible solutions for our client’s future demand. Another noteworthy trend is that of more personalized therapies and self-administration by the patients in the home setting. This has led to an increase in the range of delivery formats and packaging presentations required, expertise in which is essential. When considering the commercial packaging of biologics and biosimilars, at PCI we are able to support a diverse portfolio of conventional and speciality delivery forms. Our capabilities and expertise include the packaging of ampoules, vials, cartridges and standard prefilled syringes (PFS), as well as advanced safety syringes, auto injectors and pen devices including dial-based and reusable formats.

Our technologies provide a highly flexible approach to the packaging of parenteral products. All processes are fully scalable, allowing us to customize our solutions to meet the needs of every client in terms of pack complexity and batch size to deliver forecasted sales volumes. In addition to the increasingly complex packaging requirements, almost all biologic medicines require cold chain management. To manage this growing demand and in anticipation of future growth, PCI has also expanded its overall cold chain infrastructure. In handling biologics, we already maintain a comprehensive cold chain and ultra-cold chain portfolio with temperature ranges including refrigerated (2–8 °C), frozen (–20 °C, –40 °C, –80 °C) and cryogenic (–196 °C) for advanced therapy medicinal products (ATMPs). All cold chain storage solutions have full operational redundancy and incorporate real-time monitoring, ensuring the products do not experience any temperature excursion or exposure to conditions that may compromise quality or integrity. As part of our “build today for future demand” ethos, PCI plans to double the capacity of refrigerated (2–8 °C) storage across our UK sites, which in absolute terms means in excess of3000 pallet locations.

In line with our approach to always deliver best-in-class technologically advanced solutions, PCI has collaborated with Marchesini on this latest investment, further building on a successful and longstanding relationship. (Marchesini is a leading global provider of automated pharmaceutical packaging machines, based in Italy’s “Packaging Valley” in Emilia Romagna.)

“Leading global CDMO, PCI has further expanded its European biotech packaging capabilities with investment across Europe in both the UK and Ireland facilities”

Across PCI’s European sites, the automated parenteral packaging lines will deliver a combined initial capacity of over 50 million PFS units and 70 million vials per year, including fully integrated inspection for the critical to quality attributes (CQAs). Serialization and aggregation capabilities are also inbuilt as standard. The use of integrated and multi-layered Serialization technology ensures the highest standards of regulatory compliance, ultimately providing patients with safe and effective medicines. The new Biotech packaging lines across our European facilities will commence operations in Q2 2022.

Furthermore, to support global commercial product launches, PCI provides customers with a dedicated New Product Introduction (NPI) team to ensure a seamless technical transfer into our facilities, aiding speed to market. Globally, we support in excess of 50 product launches each year, 15 of which are from the European facilities. Our committed team of experienced professionals ensure excellence in customer service for the duration of the project, whilst providing the flexibility required to meet the ever-changing demands of the product lifecycle.

In addition to our Biotech packaging capabilities, PCI is able to provide a range of services for more traditional oral solid dose formulations, including blistering and bottling. PCI also supports the packaging of controlled drug substances, hormones and drug products containing highly potent APIs, along with medical device packaging services. In addition, we are able to offer in-house packaging development services from design to commercialization, including the ability to develop prototypes using photorealistic rendering, rapid prototyping technologies and lab scale equipment.

Importantly, all services are supported by our in-house analytical laboratories providing full global release testing including release into the EU.