Embracing single-use technologies to advance biopharma manufacturing

Manoj K Ramakrishna, Biopharma Commercial Leader-South Asia, Cytiva Lifesciences talks about Single-Use Technologies (SUTs) and explains why they are gaining prominence

Evolution of Single-Use Technologies (SUTs)

The evolution of SUTs represents a significant shift in the overall landscape of biopharma manufacturing. What began primarily with single-use bioreactors in the early 1990s¹, has expanded and evolved to include single-use components through both early upstream processes and downstream activities, extending seamlessly into commercial manufacturing. Over the past decade, the adoption of single-use technologies has experienced consistent growth, with approximately 85 per cent of all pre-commercial biomanufacturing operations now employing single-use methodologies.

The COVID-19 pandemic, which was characterised by the need to quickly roll out vaccines with greater efficacy, saw biopharmaceutical companies looking to single-use bioprocessing technologies and equipment. This shift is evident in the notable increase in the utilisation of single-use technologies in downstream clinical manufacturing, rising from 38 per cent in 2015 to 66 per cent in 2021. Similarly, in commercial manufacturing, the adoption of single-use technologies grew from 17 per cent in 2015 to 38 per cent in 2021.²

According to a research report by Markets and Markets (2021), the global single-use bioprocessing market is expected to reach $20.8 billion by 2026 from $8.2 billion in 2021, at a growth rate of 20.5 per cent ³ during the forecast period. The demand for single-use technologies in India is expected to grow in line with India’s ambition for self-sufficiency and to be a global biomanufacturing hub – the country is seen as a high-potential segment for single-use systems – backed by government support, rising private investments in bio-manufacturing infrastructure, and the presence of a skilled workforce.

Why are SUTs gaining prominence?

The single-use segment today includes an array of components, such as bioreactors, tangential-flow filtration devices, depth filters, disposable filter cartridges, media biocontainers, mixing systems, tubing assemblies, sampling systems, and others. These single-use components offer several advantages over conventional stainless-steel systems. In this regard, cost-efficiency emerges as a compelling advantage, as SUTs require less upfront capital investment, which positions them as an attractive option.

Furthermore, the twin pillars of speed and flexibility define the key benefits of the SUTs. The utilization of SUTs in biopharmaceutical manufacturing accelerates the development of products by quickly advancing development efforts. Moreover, the disposable and replaceable nature of all process parts, including hoses, biocontainers, and seals means that manufacturers have the agility to swiftly adapt to evolving industry demands.

Moving forward, prevention of cross-contamination risk stands as a linchpin in biopharmaceutical manufacturing, and SUTs excel in this regard, as is also endorsed by stringent regulatory requirements. By systematically replacing components in single-use systems, the risk of contamination is significantly reduced, particularly for processes handling potent materials such as viral vectors and Antibody Drug Conjugates (ADCs).

Another benefit of embracing single-use systems is enhanced throughput. SUTs optimise efficiency by minimizing downtime during equipment cleaning and sterilisation, leading to a more streamlined manufacturing process that keeps pace with the industry’s rapid advancements.

A closer look at the environmental implications of SUTs

As the biopharma industry continues to swiftly adopt single-use technologies for their efficiency, speed, and flexibility in R&D and manufacturing, a crucial responsibility lies on the shoulders of companies to assess and mitigate their environmental impact.

SUTs have been criticized for their environmental impact. A streamlined lifecycle assessment of single-use technologies in biopharmaceutical manufacturing reveals that the use phase with a significant contribution to environmental impact is the utilization of electricity⁴ in a cleanroom environment. By embracing higher-yielding processes⁵ that operate in less time, consume fewer resources, and are housed in more compact facilities relative to their processes, biopharma companies can achieve substantial reductions in environmental impact.

SUTs generate plastic waste, which raises concerns about their environmental impact. Biopharma companies, in this regard, should proactively assess their plastic usage and minimise their environmental impact – incorporating the principles of reduce, reuse, and recycle should guide biopharma companies in minimising plastic consumption, reusing materials, and implementing robust recycling solutions. Embracing these principles, Cytiva collaborates with Triumvirate in the United States—an environmental solutions firm—to collect their plastic film waste. This waste is then repurposed for use in various industrial applications, including composite decking, shipping pallets, and compression molding products⁶. Similar initiatives are being explored in the Asia Pacific region.

Further, the disposal of single-use materials, often through methods such as commercial landfilling or incineration, raises ecological questions that necessitate immediate consideration. Research suggests that sending single-use equipment to incineration results in as much as an 8 per cent increase, or an increase of 1.28 tons CO2 eq per 1 kg of biological bulk drug substance⁷. In this regard, exploring end-of-life options such as remanufacturing and recyclability can divert plastic waste from landfills or incineration, benefiting both the industry and the environment. To move towards reducing plastic waste from reaching landfills or incinerators, Cytiva has collaborated with TerraCycle and customers to recycle filtration devices across nine countries so far⁸.

Additionally, the SUT supply chain – comprising phases such as packaging and transportation, is also believed to carry environmental implications. In view of this, Cytiva is embracing a circular approach by working across the supply chain to develop recycling and waste-management solutions by 2025⁹.

Way forward

SUTs have gained immense significance over the past decade and will do so in the coming years. As far as environmental considerations go by exploring renewable energy sources, embracing process intensification, reducing plastic waste, switching to sustainable packaging, and exploring end-of-life alternatives, the biopharma industry can effectively address environmental concerns and make strides towards sustainability.

Furthermore, single-use components are constantly being redesigned – leading to more efficient, improved, and enhanced products. However, to truly embrace technological innovations such as the SUTs, it is imperative for the manufacturers to consistently demonstrate regulatory compliance and compatibility with the production process and final biologic drug products or vaccines. This ensures the efficacy.

Here, it becomes important to realise that single-use systems, despite their advantages may come with some risks which are mitigated by industry organisations, including BioPhorum (formerly BPOG), a global consortium of major biopharmaceutical manufacturers, through best-practices for conducting extractables studies which are widely adopted as the gold standard for testing SUS component extractables and leachables. Furthermore, Cytiva with over 40 years of validation expertise, has also played a pivotal role in shaping these standards. Contributing to critical filter validation and advocating for the adoption of continuous processing technology¹⁰, Cytiva remains at the forefront of industry advancements.

Moreover, when it comes to SUTs, it also becomes crucial to ensure that there is a thorough assessment of their design, construction, and assembly to mitigate potential quality risks related to particulate contamination. The proactive management of contamination risks should commence within the supply chain.

SUTs are, thus, here to stay and will continue to transform biomanufacturing by offering manufacturers the benefits of agility, flexibility, and minimizing cost-contamination risk. As an industry, collaboration and commitment to quality will serve as our guiding principles, so that the biopharmaceutical industry not only continues to advance innovation for the benefit of patients, but also in consideration of our impact on the planet – shaping our legacy for years to come.  

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