Entegris Blog | Ensights

3 Questions to Ask When Choosing a Secondary Container for your Bulk Drug Substance

Written by Entegris | May 25, 2022

Freezing down bulk drug substance (BDS) isn’t something you can play around with. This is a high value product where any failure or contamination due to the bag breaking can lead to delays in medicine getting to the patient. Making sure you pick the right solution to protecting that product makes a big difference.

Here are three questions you should be considering:

  1. How does this shell protect better than what I already have?
  2. Will this container maximize storage space in our freezer?
  3. How will this fit into my organization’s facility?

With large investments in drug development, a complex global supply chain and regulatory requirements, the journey to the patient is formidable. Next time you’re looking for a secondary BDS solution, ensure your manufacturer takes these factors into consideration:

Material Performance

  • Offering robust solutions that won’t comprise during a bag drop, throughout the freeze/thaw process and in transport that will meet performance demands.

Support and Flexibility

  • An applications engineering team, offering bespoke and off-the-shelf solutions to create end-to-end solutions committed to quick response times.

Supply

  • Having quick turnaround and availability for wide variety of offerings.

Cost

  • Looking at total value, how does the competition fare? Does the performance, support and supply compete?

Scalability

  • Providing reliable BDS freeze/thaw solutions allowing customers the ability to scale their operations from initial R&D evaluation to large scale production.

Trusted Partner

  • Having total support providing robust and reliable single-use solutions for bulk drug freeze thaw backed by a robust supply chain.

We understand the implications of a faulty container for your single-use solution and continue to work on ways to protect the integrity of product throughout the biopharma process. Ensure your next partner does the same.

For more information about our secondary containers and single-use solutions,
visit our website: cold-chain bioprocessing.