Current Edition

Demand, Design, Delivery: High Potent Packaging at PCI Pharma Services

In a fragmented marketplace, drug discovery organisations are increasingly looking to work with fewer outsourcing partners. As such, CDMOs that are able to provide true end-to-end services are becoming more in demand. By partnering with full-service CDMOs, drug discovery organisations simplify and de-risk their supply chain, saving both time and money by maintaining production under one roof, or within one organisation. Shaun Engelhardt, PCI Pharma Services’ Director of Engineering and Innovation, discusses how recent investments in their UK-based high potent facility has created this ideal scenario for clients.

Demand-led Investments in PCI

Drug products containing highly potent APIs (HPAPIs) present unique challenges to CDMOs, and not all of them have the true capability to manufacture or package them from clinical to commercial scale. PCI has significant experience in this arena, with our first Contained Manufacturing Facility (CMF) launched in 2013. With industryleading containment solutions capable of handling APIs down to an OEL of 0.01 µg/m3, and geometrically scalable equipment trains able to manufacture lab- and commercialscale batches, the CMF proved hugely successful.

However, PCI is always looking for ways to provide a greater level of services to our clients. As such, recent CAPEX investments have led to the construction of a brand-new potent packaging facility at the Tredegar site, alongside a second CMF that doubles our commercial-scale high potent manufacturing capacity. The result is a true end-to-end, integrated service solution for clients who need their highly potent solid oral products manufactured, packaged and distributed globally from a single site.

This investment is a significant milestone for PCI and particularly the Tredegar site, allowing an increased capacity to manufacture and package our clients’ products from clinical supply to commercial launch. By investing in these new facilities now, we are confident that PCI can remain a major player in this arena for years to come.

Design Considerations

When designing such a facility, an important early step is for the team to consider what an ideal, best-in-class facility should include. Amongst these considerations were the needs and demands of the marketplace; any fundamental regulatory requirements; the industrial best practices, and whether any of these are likely to remain steady or change in the years to come. Once these aspects were determined, we can then identify a ‘wish list’ and an outline specification. For example, having an excellent flow of materials is vital, ensuring a seamless movement of the drug product from manufacture to primary and secondary packaging, and onto the final step of serialising the packaged product. Another important factor is ensuring a good flow of personnel in terms of how staff enter the facility, where they gown, and how they enter the production areas.

These expansions at the Tredegar facility are the largest in terms of footprint that the site has undertaken. As such, a great deal of consideration was required in terms of the aforementioned personnel and material flows, as well as the facility design, engineering requirements, environmental monitoring systems for the critical environments, and regulatory influences. The integration into the existing site was therefore vital, particularly in light of any potential future site expansions.