Current Edition

Talking Point with PCI Pharma Services

PCI Pharma Services is a trusted partner for globally integrated CDMO services. Can you tell our readers the brief history of your company, how the company got started and your growth so far?

Established in 1971 and trading as Packaging Coordinators Inc. (PCI), the company provided contract packaging solutions to the pharmaceutical industry. Over the last decade, PCI has made a number of strategic acquisitions to both increase its global packaging footprint as well as add manufacturing capabilities. One such acquisition in 2014 was Penn Pharma, bringing with it a state-of-the-art contained manufacturing facility for the safe processing of highly potent drug products. In 2015, the organisation rebranded under the name PCI Pharma Services and has since continued to grow both organically and by way of further acquisitions, with Lyophilization Services of New England (LSNE) being the most recent acquisition building upon its expertise in speciality manufacturing, delivering on the company strategy to become a truly integrated, global, CDMO. Today, PCI Pharma Services is a global $1 billion CDMO with 30 GMP facilities throughout North America, Canada, the UK, Europe, and the Asia Pacific region. We are proud to serve in excess of 1,700 customers with unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialisation, delivering speed-to-market and commercial success for our customers. Our continued growth enables us to support over 3,100 clinical trials, over 450 commercial molecules, and each year launch over 90 commercial products. Our industry-leading experience, operational flexibility, commitment to safety, supported by innovative technologies and our exemplary quality and regulatory record make us the partner of choice for biopharmaceutical companies around the world.

PCI is committed to supporting clients at every stage of the clinical cycle, delivering best-in-class services efficiently and effectively. What are the core clinical trials services you provide and where?

Our clients come to us seeking solutions to often complex and unique opportunities due to our reputation in offering unmatched flexibility, a client-centric experience and a consultative approach. We deliver a seamless clinical service for almost all dosage forms and drug products including pharmaceutical development, clinical manufacturing, packaging, labelling, storage and distribution. Our scalable solutions ensure we are able to support our clients from early first-in-human (FIH) studies through to late phase clinical trials and ultimately commercialisation. Through facilities in North America, Europe and the Asia Pacific, PCI provides a global service with a localized focus, delivering over 200 protocols a year in over 100 countries, utilising best-in-class technologies combined with experienced and dedicated teams.

PCI’s “Contained Micro-Dosing Xcelodose® Technology” is a very innovative solution. Can you explain what that is, and why do you claim that this technology leads to faster first-in-human studies?

Xcelodose® is a precision powder micro-dosing system that allows API to be filled directly into capsules and vials. This approach removes the need for the development of a powder blend, as would be the case for a more traditional development process. At PCI, we operate both the Xcelodose® 120 and the 600S models, filling up to 120 and 600 capsules per hour respectively, making them ideal for clinical manufacture from early to later stage clinical programs. We have also invested in Xcelohood™ and Xceloprotect™ containment systems, further enhancing our world-class engineered contained manufacturing capabilities for the safe processing of highly potent drug products. By eliminating the requirement for preformulation activities, excipient compatibility and associated stability studies, as well as simplification of method development processes, utilizing the Xcelodose® technology allows products to be manufactured and delivered to the clinic up to 6 months faster than the more traditional route. Dosing directly into capsules also helps to reduce the amount of API required, helping to eliminate wastage of often-valuable APIs which is particularly important at the early stages of proof of concept if API is in short supply.