Leading pharmaceutical provider PCI Pharma Services will bring its expertise to the stage at Cell and Gene Therapy World when it presents an international case study on ‘The New Cold Chain Challenge’
Leading pharmaceutical provider PCI Pharma Services will bring its expertise to the stage at Cell and Gene Therapy World (25-27 January 2016, Washington DC, US) when it presents an international case study on ‘The New Cold Chain Challenge’.
On January 27, Rachel Griffiths, Associate Director, Technical Services, PCI, 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 ‘Logistics: What Progress in Enabling the True Globalization of Cell and Gene Therapies?’.
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 while 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,' said Griffiths. '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 industry’s demands. It’s a growing and developing sector of the industry, so we’re advising people to pre-register now to be sure of a seat.'
PCI is a market leader in the provision of international cold chain management services and has extensive capacity, flexibility and unrivaled expertise to accommodate clients’ refrigerated and frozen storage and distribution requirements. PCI’s 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.