Home / Knowledge Centre /
Blog

What are the considerations for handling a drug product with Ultra-Low Temperature requirements?

Advanced Therapy Medicinal Products (ATMPs) offer ground-breaking opportunities for treatment of disease. ATMPs, such as cell and gene therapies, require very specific measures and pose unique challenges throughout the supply chain. Many of these products must be held at ultra-low temperatures (ULT) between -20 and -80 degrees Celsius, with very little scope or time for deviations away from their target temperatures. 

When working with a CDMO, a manufacturer should appreciate that this is a bespoke and collaborative process, meaning that it is vital to share all information that is known about a product’s temperature parameters and handling requirements from the initial stages. If a product’s temperature has not been assessed, the manufacturer should partner with the CDMO to conduct a proof-of-concept work. This will assess any changes to the product’s temperature over the course of various handling procedures. The goal of this activity is to ensure repeatability of results, and to prepare a detailed report on what will be required throughout the process. 

Key considerations when defining, and streamlining the packaging process include: 

  • The allowable time out of condition  
  • Conditioning time requirements when taken from one environment to another  
  • Material specifications for labels and cartons 
  • Label design 
  • The need to pre-print batch numbers and expiration dates on labels and cartons to minimize time of controlled environment 
  • The final pack-out configuration with any ancillary components (i.e., patient information leaflets) 
  • The level of serialization aggregation required (from carton to shipper to pallet, for example)  
  • Temperature controlled distribution and global supply chain

It is important to allow sufficient time for process validation, and also equipment validation depending on the client and product requirements. After establishing the temperature parameters for the ATMP, a validation cycle should be implemented. Performing all validation activities and reporting takes time, manufacturers should be prepared for a 3-4 month validation window. 

Successful partnership with an experienced CDMO can ensure a customised approach to the handling of an ATMP. Having a knowledgeable team of technical experts work intensively with you facilitates a deep understanding of both your product and patients.

Read about why Almac Pharma Services was a natural choice for PTC when looking for a partner to design the supply chain for a new brain-infused gene therapy for children suffering with a rare inherited condition: Irish Times | Critical supply chain to save lives of very ill children designed and run from Ireland

Find out more about our Ultra-Low Temperature capabilities today.

Download here instantly

This website uses cookies. By continuing to browse the site, you are agreeing to our use of cookies