PCI Pharma Services Announces European Clinical Site Expansion to Support Growth

September 20, 2016 – Manufacturing and Packing –

Philadelphia, USA – September 20, 2016. Leading pharmaceutical outsourcing services provider PCI Pharma Services (PCI) has announced the expansion of its Bridgend UK Clinical site. Ground works and Construction began on September 12, 2016 of a new Clinical services facility at Central Park on Bridgend Industrial Estate, one of four PCI European-based locations supporting investigational study materials.

The facility expansion at the Bridgend location will provide 37,500 sq ft of additional space in support of the secondary packaging and logistical services provided at the Clinical Services Center of Excellence. PCI features highly specialized capability and expertise in supporting temperature-sensitive therapies, including Cold Chain and Ultra Cold Chain, at temperatures ranging from Controlled Ambient 15-25∞C, 2-8∞C, down to -20∞C, -30∞C -40∞C, -60∞C to -90∞C and including liquid nitrogen vapour phase storage below -150∞C for Advanced Therapeutic Medicinal Products (ATMPs), as well as bespoke refrigerated and frozen temperatures according to client needs.

This is the latest in a series of significant investments by PCI in developing its Bridgend site as its business has flourished: most recently with a purpose-built and dedicated -40∞C facility; as well as a broader Cold Chain capacity expansion that increased site storage by over 400%; in addition to continued expansion of frozen storage at -80∞C. These investments at Bridgend mirror PCI investments at other European and North American sites, supporting services for Clinical Trials and its considerable business growth in this segment.

The new building, which is expected to open for business in early 2018 following internal fit-out and a period of validation and licensing, will be adjacent to PCIís current facilities at Bridgend. Purpose-built for storage and Clinical therapy distribution, there will also be additional office space to meet staff growth plans, demonstrating PCIís commitment to and continued investment in its Clinical provision.

Kevin Williams, Operations Director at PCI, said: ‘We are excited to see the initial construction begin on our new Clinical facility expansion. With the market growth in Biologics and the advent of Biosimilars, the need for temperature-controlled therapies continues to increase dramatically.

‘It is estimated that up to 37% of all drugs in the Pharmaceutical Industry pipeline currently are Biologics. Likewise with advances in cell therapies and other cell- and tissue-derived treatments, there is increasing need for cryogenic temperature storage. These trends, coupled with investigational studies increasingly being executed in more distant geographies, has demonstrated the need for expert specialist services in support of investigational studies.

‘PCIís continued investment in this area allows our clients to realize a safe and secure supply chain, ensuring their life-saving treatments are delivered on a timely basis to patients around the world with the highest degree confidence and assurance.’

Complementing its services for commercial medicines, PCI Clinical Services provides a broad range of support for investigational study materials including drug development and manufacturing, packaging and labeling, as well as global network for storage, distribution and returns management for providing study materials to investigational sites around the world.

To find out more about PCI, please visit www.pciservices.com.

About PCI

The global healthcare industry trusts PCI for the drug development solutions that increase their productsí speed to market and opportunities for commercial success. Only PCI brings the proven experience that comes with more than 50 successful product launches a year and over four decades in the healthcare business. Leading technology and continued investment enables us to address global development needs throughout the product life cycle ó from Phase I clinical trials through commercialization and ongoing supply. Our clients view us as an extension of their business and a collaborative partner, with the shared goal of improving patientsí lives. For more information, please visit www.pciservices.com or follow us on Twitter at @PCI_Social.

Join PCI Pharma Servicesí experts at this yearís CPhI Worldwide event (Barcelona, October 4-6, 2016)

PCI has secured two slots at the ICSE Exhibitor Showcase: the presentations will focus on the safe handling and manufacture of Potent Molecules (October 4 at 13:30-13:55) and Serialization strategy and implementation (October 5 at 12:00-12:25). Visit the PCI Pharma Services stand at 3B16.

Contact

Chantel Richman / Carrie Lowe at Remarkable Content

chantel.richman@remarkablegroup.co.uk

carrie.lowe@remarkablegroup.co.uk

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