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20 June 2019

Single use, multiple applications

At the end of the week I find myself throwing away over 20 bioreactors, never to be used again. Has my experiment failed? Am I going to be fired? Will my CEO have to ask his ex-PhD supervisor for a small loan of a million pounds? Hopefully none of the above because these are single-use bioreactors, pre-sterilised, ready to use off-the-shelf as a part of a sustainable system.

Single-use technologies can be applied throughout all stages of the bioproduction process, they are modular and designed to fit customers’ needs, with manufacturers jumping over each other’s heads to offer new advancements.

The global market is projected to keep growing up to $4.3 (£3.2) billion in 2021. Single-use technologies are here to stay, so what is it all about?

Perhaps the biggest impact and the flashiest equipment can be found in the upstream labs, with stainless steel juggernauts being phased out by plastic bags, integrated optical sensors and easily scalable vessels.

With the current advances in biopharmaceutical manufacturing, the trends are turning towards faster turnarounds, multiple products and smaller batches.

Single-use bioreactors are designed to meet these requirements, ranging in size from several millilitres to thousands of litres, suitable to take a product from early development all the way to large scale manufacturing.

Many market leaders provide complete solutions for process development across a wide range of scales, facilitating the need for high throughput and quick turnaround.

ambr®15 system developed by TAP biosystems (part of Sartorius Stedim) provides a multi-vessel platform for testing a range of conditions using an integrated Design of Experiments (DoE) approach.

ambr®15 system also provides control and monitoring capabilities of full scale bioreactors at millilitre scale without compromising scalability of the vessels. Oxford Genetics makes use of this system as a core part of the upstream process development and production optimisation, fully embracing the benefits of single-use bioreactors.

As the demand increases so does the size of bioreactors, with multiple suppliers offering a wide range of soft and hard plastic vessels and bags tailored for specific applications.

Single-use bioreactors used in biopharmaceutical manufacturing currently reach 2000L capacity and are usually a less risky investment than a dedicated stainless-steel reactor.

Single-use technologies improve process flexibility and safety, provides pre-sterilised environment and eliminate the need for extensive cleaning in place and reduce process timeliness.

It’s a new approach to process development and manufacturing, flexible to work with multiple products, e.g. (proteins, viruses and cells) but this is not where the single-use revolution ends.

Upstream processing is only the beginning of the biologics lifetime and single-use technology follows it throughout the journey to the patient. Single-use solutions are available for clarification, tangential flow filtration and chromatography. They reduce preparation time, provide flexibility and in most cases are easily scalable with the process development progress.

Suppliers are currently providing complete solutions for single-use processes and in extreme cases even entire purpose-built manufacturing plants with highly flexible, pre-validated equipment is intended to reduce set-up and regulatory approval timelines.

However, single-use technology is not without its flaws. A common consideration are leachables and extractables which are impurities that can be introduced into the process through interaction between the materials used in single-use vessels and media, cells and products.

While suppliers continue to improve their technology to limit the impact of leachables and extractables, the drug manufacturers must demonstrate that the materials used in the process do not affect the final product quality.

This highlights the increased pressure on the supplier to comply with specifications and regulations and to ensure product consistency. Some drawbacks of single-use technology are balanced by their benefits e.g. the environmental impact of increased waste is balanced by reduced energy and chemical use for sterilisation and cleaning.

As you can see, single-use technology is making its way into bioprocessing, creating new opportunities but also bringing new challenges for suppliers, manufacturers and regulators. Given the unique benefits and drawbacks it’s easy to recommend single-use technologies for flexible processes.

However, stainless steel remains attractive for large scale single-product facility, but where does the industry draw the line? As always, the decision lies with individual companies, leaders and scientists who must ensure best fit for their process and business.

If you would like to learn more about applications of single-use technologies at Oxford Genetics or would be interested in discussing a collaboration, get in touch.