Pharmaceutical outsourcing services provider PCI Pharma Services (PCI) has announced the expansion of its Bridgend UK clinical site.
Ground works and construction began on 12 September of a new clinical services facility at Central Park on Bridgend Industrial Estate, one of four PCI Europe-based locations supporting investigational study materials.
The expansion will provide 37,500ft2 of additional space in support of the secondary packaging and logistical services provided at the Clinical Services Centre of Excellence.
PCI has highly specialised 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 more than 400%; in addition to continued expansion of frozen storage at -80°C.
These investments 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 PCI’s current facilities at Bridgend.
Purpose-built for storage and clinical therapy distribution, there will be additional office space to meet staff growth plans, demonstrating PCI’s 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, have demonstrated the need for expert specialist services in support of investigational studies.
'PCI’s continued investment in this area allows our clients to realise 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 labelling, as well as a global network for storage, distribution and returns management for providing study materials to investigational sites around the world.
