Cell and Gene Therapy World: PCI Pharma Services Expert Presents Case Study of ‘The New Cold Chain Challenge‚Ä™
January 12, 2016 – Manufacturing and Packing –
Philadelphia, USA – January 12, 2016. Leading pharmaceutical provider PCI Pharma Services will bring its expertise to the stage at Cell and Gene Therapy World (January 25-27, 2016) when it presents an international case study on ëThe New Cold Chain Challengeí.
On January 27 at The Grand Hyatt, Washington, Washington DC, PCIís Rachel Griffiths, Associate Director, Technical Services, will outline how the company used its cold chain storage technology to solve the challenges of a trial in which approximately 100 patients were treated in the UK, Germany and Netherlands with one study site in each country.
The presentation will be part of the session entitled ëLogistics: What Progress in Enabling the True Globalization of Cell and Gene Therapies?í
The challenge of the case study was that treatment was autologous, so samples were taken from the patient in Europe and transferred under dry ice to the US where the material was transformed into an autologous therapy and then flown back to PCI in the UK. There it was stored briefly whilst the Qualified Person (QP) release was completed and then sent back to the clinical site for patient treatment.
The case study presentation will discuss the logistical aspects of the study regarding maintaining temperature, timelines, sample integrity and how this was put into place for the trial, and the QP release process. It will also discuss the regulations involved, because the initial sample comes under the Human Tissue Authority (HTA) and transfers into the MHRA/clinical trial regulations upon receipt into the manufacturer.
‘Cell and Gene Therapy World is a global stage for PCI to demonstrate how our leading expertise and technology is ready to solve the new problems faced by pharma companies in the modern age.
‘I hope the information we convey adds some real-world, practical detail to the wider session and gives attendees a better grasp of how the technology is responding to the pharma industryís demands. Itís a growing and developing sector of the industry, so weíre advising people to pre-register now to be sure of a seat,’ said Rachel.
PCI is a market leader in the provision of international cold chain management services and has extensive capacity, flexibility and unrivaled expertise to accommodate clientsí refrigerated and frozen storage and distribution requirements. PCIís extensive cutting-edge cold chain shipping technologies and storage areas are all fully validated, continuously monitored and alarmed, and offer different storage temperatures, from Controlled Ambient (15-25∞C) down to -196∞C.
To hear more from Rachel Griffiths and the PCI team, register for Cell and Gene Therapy World by visiting: http://pciservices.com/events/cell-and-gene-therapy-world-2016
