PCI Pharma Services (PCI), full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, has announced a significant expansion of its onsite cold chain storage capabilities at its Hay-on-Wye, UK site.
The announcement is the latest in a series of strategic investments at PCI, demonstrating its market-leading presence in biotech therapies, supporting medicines destined reach to more than 100 countries around the world.
As a Centre of Excellence for clinical and commercial packaging, PCI’s Hay-on-Wye site is always seeking to improve on the services offered and to provide innovative market-leading solutions based on customer need. During the past 2 months alone, development at the site has included
- the addition of onsite 2-8 °C refrigerated storage by 200 pallet locations – increasing onsite capacity by a further 250%
- additional expansion of on-site frozen storage – including the doubling of onsite -40 °C freezer capacity and the further doubling of onsite -80 °C freezer capacity
- additional serialisation lines – doubling PCI’s serialisation capabilities at Hay in advance of FMD requirements
- investment in equipment – enabling the labelling, packing and serialisation of vials, auto-injector pens and syringes.
PCI has continued to make important investments in its cold chain and serialisation offering across its global network as key elements in its business growth strategy.
PCI’s cold chain investment reflects increasing market demand for parenteral delivery forms and medicines requiring strict end-to-end cold chain logistics. It recently celebrated a significant milestone in the protection of global drug products with the installation of its 80th serialisation line, further extending its advanced position across its global supply network.
“A large proportion of the 50 products we launch on average each year are drugs with end-to-end cold chain storage and logistics needs. Meanwhile, across PCI we have taken a long-term approach to ensuring highly specialist serialisation and anticounterfeiting preparation for the new global security requirements that will be coming into effect soon,” commented Gareth Lewis, PCI’s Commercial and Supply Chain Director at Hay-on-Wye.
“These extensive installations at our Hay site reflect our continued and considerable investment in both areas, and our commitment to ensuring the highest quality service for our customers worldwide.”
PCI has been actively serialising commercial products for the US, European and other international markets for more than 6 years. During the past 2 years, PCI has focused on tripling its overall serialisation capacity across its global network in compliance with the US Drug Supply Chain Security Act (DSCSA), and the impending European Falsified Medicines Directive (EU FMD), as well as in-country requirements in emerging markets.
These additional serialization lines at Hay-on-Wye enhance the site’s existing security capabilities in advance of the final phase of the EU FMD, which will be implemented from 9 February 2019.
PCI’s increased Cold Chain facilities for 2-8 °C, -40 °C and -80 °C temperatures at its Hay-on-Wye site support medicines needing specific refrigerated or frozen conditions. The additional storage is complemented by further infrastructure to meet fast-growing market demand for injectable delivery forms with vial labelling, syringe labelling and assembly, as well as labelling and assembly of autoinjectors and pens.
“The expansion at our Hay site reflects our strategy for investment across our global PCI network, which is focused on delivering industry leading customer experience through state-of-the-art technologies, offering secure, adaptable, easy-to-use and scalable solutions,” said Chris Dobbs, PCI Head of Technical Engineering at Hay-on-Wye.
This facilities installation announcement is the latest reflecting PCI’s commitment to ongoing expansion and investment in global cold chain infrastructure, as well as continuing to make considerable capital investments in facilities and capacity expansion.