VALIDATED COLD CHAIN LOGISTICS
FOR ANY TEMPERATURE RANGE
Medical treatments are becoming more complex involving human cells and genetically manipulated human cells. The results of these treatments have been truly amazing, dramatically restoring functions to the patient’s body that have been absent since birth. Developments in Cell & Gene Therapy (CGT) are happening so quickly that the technology to support cold chain logistics is desperately trying to keep up with extraordinary user requirements. CGT shipments require highly intricate timing, absolute compliance, and dedicated personnel performance above and beyond the call of duty.
In the EU the donation, procurement and testing of Tissues and Cells are covered by Directive 2004/23/EC, whereas the processing, preservation, storage and distribution are regulated by other Community legislation e.g. The ATMP Regulation. The further manufacturing steps are covered by Directive 2001/83/EC relating to medicinal products for human use.
2 – 8° GENE & CELL THERAPY SHIPMENTS
Cells needed for Gene & Cell Therapy (CGT) are normally withdrawn from patients in hospital, transferred by road at 2-8°C to an outside laboratory for processing and then transported back to the hospital for re-administration to the patient. The challenge comes when the outside processing laboratory is >1,000Km away, in a different country on a different landmass and the cells need to be strictly maintained at 2-8°C and after expansion and processing delivered back within 24 hours for administration to the patient. With security increasing at borders and the x-ray of trucks and cargo almost obligatory, CGT Shipments require specialised, validated temperature controlled transport containers and careful planning and coordination with border authorities.
At Biostór we are currently involved in a number of ground-breaking CGT trials. Contact us before applying for Marketing Authorisation or if you need advice for upcoming shipments. Every product has specific requirements so that each specific shipment must be carefully risk-assessed.
LN2 DRY SHIPPERS
LN2 Dry Shippers, with their 10-14 day window at -190°C, have proven to be extremely effective and durable for effortlessly transporting cryopreserved human cells around the globe. However, real-time autologous therapies, requiring the transport of cooled live cells, present new challenges for the logistics industry and the competent authorities policing our borders.
Transport conditions have a crucial impact on the quality of CGT products and samples. The Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products (ATMP) state: ATMP Transport conditions should be defined in writing; Transport conditions should be qualified; Transport conditions of samples being sent for testing should be representative of the batch; Transport conditions of samples and products should be checked before certifying any batch of CGT and comply with the terms of the Marketing Authorisation (MA).
DRY ICE SHIPPERS
The procedures for shipping frozen biological samples on Dry Ice are straightforward and reliable. Biostór Dry Ice shippers have optimised packaging for efficient shipping and handling of frozen biological samples @-80°C. These shipments typically travel as non-infectious specimens under UN 3373 Biological Substance Category B and meet all IATA specifications, ensuring operator protection and compliance with regulations.
The 72 hour validated shipper with internal dimensions of 255 x 210 x 170 mm and a payload ~1 litre. And the 96 hour validated shipper with internal dimensions of 320 x 320 x 320 mm and a payload ~750 ml or four standard cryoboxes.
The roles and responsibilities for compliance with the defined transport conditions should be described in a Service Level Agreement (SLA) with the transport provider. The people responsible for Production and QC/QA, need to approve the validation of the transport conditions.
BIO-LOGISTICS MONITORING & TRACKING
Temperature control and maintenance of the cold-chain is critical to product, sample quality and patient safety. Biological specimens have precise temperature requirements for storage and distribution. Cell and Gene Therapy products have highly specific temperature specifications from production through storage to distribution which are specified in the terms of the Marketing Authorisation (MA).
The maintenance and monitoring of transport temperatures presents a challenge due to the impact of the environment and the constantly changing environmental conditions throughout the year.
Biostór supply a wide variety of monitoring solutions from high spec, cost effective data loggers to advanced temperature and location tracking systems which provide our clients with peace-of-mind and reassurance that the transport conditions are in compliance. We utilise sophisticated GPS tracking and real time data visibility for road based cryopreserved shipments of human cell therapy products throughout Europe.
Ask the Expert Team at Biostór to manage your Cold-Chain Transport.
30 plus years of Supply Chain know-how
EU licensed Tissue & Cell Establishment for distribution of Cell Therapy products throughout the 28 countries of the EU
Qualified/validated transport equipment, temperature Controlled Packaging
24/7 real time monitoring & GPS tracking
Responsible person for management of all QA relevant aspects
Risk assessments and Contingency Planning
- Validated Shipping
- Comprehensive SOPs in place
- Packaging & shipping in compliance with: ISTA, UN3373, UN2814 and IATA
- Customised and uniform shipping containers
- Shipments in Liquid Nitrogen Shippers, Liquid Nitrogen Freezers, on Dry Ice, Cold Packs or Ambient
- Network of trusted agents throughout Europe.
|Guidance Documents for Cold Chain Logistics|
|DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells|
|COMMISSION DIRECTIVE 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells|
|COMMISSION DIRECTIVE (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.|
|REGULATION (EC) No 300/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002|
|IATA Dangerous Goods Regulations, Division 6.2 Infectious Substances, 58th Edition, January 2017|
|IATA Dangerous Goods Regulations, Packaging Instruction Y645|
|Regulations for UN3373 – http://www.un3373.com/info/regulations/|
|WHO Guidance on regulations for the Transport of Infectious Substances 2007– 2008, WHO/CDS/EPR/2007.2|