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Single Use Systems in Biopharmaceutical Manufacturing

17 Nov 2022

Nigel O'Leary

With recent announcements of new facilities that will utilise Single Use manufacturing systems from companies such as MSD, Zoetis, Janssen and Regeneron and with companies such as Meissner and Artesyn manufacturing such systems here in Ireland it’s clear that Single Use Processing is becoming a key platform for the biopharmaceutical industry.

With recent announcements of new facilities that will utilise Single Use manufacturing systems from companies such as MSD, Zoetis, Janssen and Regeneron and with companies such as Meissner and Artesyn manufacturing such systems here in Ireland it’s clear that Single Use Processing is becoming a key platform for the biopharmaceutical industry.

The name suggests, Single Use systems are designed to be utilised purely for the manufacture of a single batch and then disposed of in their entirety, with new components then installed for the next batch whether that is for the same drug or a different one.

The production of biopharma products e.g., complex drugs, vaccines and therapeutic proteins using living materials, is much more complex than that of traditional, chemistry-based Pharma products. As a result, they are overly sensitive to any deviations in the process or contaminations. Previous systems using large stainless-steel bioreactors required extensive cleaning and sterilisation between processes requiring large amounts of chemicals, water, and energy due to the extreme temperatures involved. One key advantage of Single Use processing is the elimination of potential contaminants in the system using new sterile components for each batch. This also leads to large savings, for example, one study has shown a 46% reduction in water and energy usage.

This can also increase the flexibility of a site in terms of reducing scheduling times, improving changeovers, increasing operational efficiencies and, in many cases, reducing the cost of production.

There are some trade off’s though, chiefly the added testing required for Extractables and Leachables and the question around Sustainability.

Given that the products in a Single Use system are in constant contact with different types of plastic and polymers a key component of the testing to ensure their safety is to check if the system itself has introduced any contamination. Extractables covers compounds that can contaminate the product because of extreme conditions such as the presence of a solvent or high temperatures whereas Leachables are compounds that can contaminate the product just by exposure the normal conditions of the system. The testing involved usually uses HPLC or a Mass Spectrometry such as ICP-MS, GC-MS or LC-MS.

Sustainability is a key consideration in Single Use systems; after all it involves disposing of plastic components after each batch. Surely that must be worse for the environment than a reusable system that could be built to last for years or decades. This is still an important debate in the industry, but Cytia produced several Life Cycle Assessment reports that have been peer reviewed and they show that when a holistic view of the system is taken, for example factoring in the high energy cost and water usage of stainless-steel systems, Single Use can deliver a lower carbon footprint. Plus, a 2020 report on Pharmaceutical Sustainability showed that less than 0.01% of global plastic waste generated annually stem from single-use technologies used in biopharma.

Nigel O'Leary is Assistant Manager with Brightwater's Life Sciences division