January 18, 2019

Why single use systems are the optimal solution when storing and shipping frozen substances

At Single Use Support we have been pondering the processing and – more importantly – the shipping of frozen biopharmaceutical substances utilizing single use systems. Our developments on the basis of single-use bioprocess containers offer manufacturers of biopharmaceuticals an almost 100% reliable logistics process for liquid substances such as single-use bags.

But why single-use?

It has become standard procedure to geographically detach the processing of biopharmaceutical substances from production of the final medicinal drug product: Large batches of the active ingredient are being manufactured at one location; the ingredient is then divided into many smaller frozen units that are shipped to various sites around the globe for the final processing.

By now, integrated single use freeze-thaw systems with single use bags, hoses and connectors have become standard as they offer higher efficiency and flexibility while at the same time being more cost-effective. The ideal frozen storage and shipping solution for biopharma.

The freezing of biopharmaceutical substances in single use containers offers manufacturers of biopharmaceutical drugs the following advantages:

  • increased range
  • increased process flexibility and efficiency
  • reduced demand for capital
  • reduced labor costs thanks to processing in batches
  • increased number of patients treated in a shorter period of time
  • no cleaning and sterilization required for single use systems
  • reduced maintenance and validation times
  • large volumes of expensive drug substances can be frozen in batches to facilitate the production of medicinal drugs on the basis of commercial or clinical real-time requirements

The same applies to autologous cell therapies like CAR-T. In order to safeguard patient safety, a smooth shipping process is imperative. The concerned patients’ cells are collected at the hospital and then sent to the lab for manipulation before being returned to the hospital for injection.

Time and safety play a crucial role. Due to their already mentioned advantages, single use systems can contribute to an improvement of ailing patients who receive cell or gene therapies.

Why it makes sense to freeze drug substances for storage and shipping

Basically, it is far more reliable and practical to store and ship biopharmaceutical liquids in a frozen state. Medicinal drugs made of big molecules are particularly prone to being damaged – and damages can be prevented by freezing valuable liquid drug substances. Like this, the drug’s biological integrity is preserved while necessary logistical measures are organized. Furthermore, freezing ensures the quality of biopharmaceutical products in-between the separate production steps.

Frozen substances make it significantly easier to comply with temperature check requirements. In addition, frozen biopharmaceuticals through a pharma freezer have less interaction with their containers than non-frozen liquid substances, plus mechanical stress can be clearly reduced. There is no more need to move giant containers between premises or even between countries.

The integrity of liquid substances is particularly important in case of gene-, cell- and tissue therapies. All of those therapies are expensive and valuable. Factors such as time and patient safety play major roles.

The advantages of freeze-thaw based on single-use

Single-use freeze-thaw systems contribute to a simplified quality management for biopharmaceutical liquids. Contrary to freeze-and-thaw processes in stainless steel tanks or bottles the risk of cross contamination is significantly reduced when using single use systems. Manual interventions during the freezing and thawing processes, as well as during handling and shipping become void.

Liquid substances contained in single use bags can be frozen and thawed more consistently, which leads to a more homogenous compound of biological components and – as a result – to a far more stable product. This is a result of the reduced distance from the container’s edge to its center. Furthermore, it is easier to store single use bags than stainless steel reactors – they can simply be stored in freezers of varying sizes.

Finding the right single use system

For shipping purposes, biopharmaceutical substances are normally stored at temperatures between -4 and -112 degrees Fahrenheit (-20 und -80 Grad Celsius). A successful freeze & thaw process requires a thorough check of the single-use system’s physical and thermal properties as well as the substance’s integrity and quality.

In order to guarantee all of the above, tried-and-tested, well-built and robust single-use systems are required. They should have been thoroughly tested in real-life conditions, taking into account normal and abnormal scenarios such as variations in temperature. The best validation results can always be achieved in cooperation with your supplier’s scientists and engineers.

Apart from the single use bag containing the liquid, the protective sleeve (single-use bag protection), hoses and connectors as well as the secondary packaging need to be designed to protect the valuable content not only throughout the entire shipping process but also its entire life cycle.

At Single Use Support we offer exactly that: Precise and tested single use systems that offer a reliable freeze-thaw process and in addition cover the entire logistics process. And what is even more: Our standalone systems are maximally scalable and efficient, irrespective of the brand of single use bags you use. Why don’t you see for yourself? This video shows you our entire end-to-end process.

Frozen single use bag in RoSS shell single use bag protection

Michael Eder

Senior Marketing Manager