How Do Single-Use Bioprocessing Systems Help Biomanufacturers Improve their Operational Efficiency and Productivity?

Key takeaways:

• Introduction
• Growing popularity of single-use bioprocessing systems
• Latest product launches in the sector

Single-use bioprocessing refers to the use of plastic or polymer materials such as polyvinyl chloride, polyethylene, polycarbonate, polypropylene, etc., in biomedical and pharmaceutical applications. The term ‘single-use’ denotes that these products are specifically designed to be used only once and then disposed of. Typically, these single-use solutions are used to develop upstream processing systems such as bioreactors, samplers, media bags, bioprocess containers, membrane absorbers, and disposable mixers. However, with advancements in polymer sciences, these compounds are now also used for downstream bioprocessing systems, including connectors, disposable filter cartridges, tubing, etc.

Increasing preference for single-use bioprocessing products impacting the industry positively

In the last few decades, especially after the global epidemics and pandemics such as H1N1 flu and COVID-19, the demand for biopharmaceuticals has increased drastically. Also, government entities and private medical companies are investing heavily to increase the scope of healthcare infrastructure to make these services available, affordable, and accessible to all sections of the global population. Along with this, advancements in biomedical instrumentation technologies have increased the utility of single-use compounds as they are now also used for manufacturing biologics such as vaccines and monoclonal antibodies. Due to these factors, the single-use bioprocessing industry, which accounted for $7.0 billion in 2020, is anticipated to gather a revenue of $38.8 billion by 2030, rising at a CAGR of 18.4% during 2021-2030.

Another important reason behind the growing adoption of single-use products in biomedical applications is that they help reduce energy consumption significantly. Long-term research has demonstrated that biotechnology companies using these advanced products have around 40% lower carbon emissions than those compared to businesses having stainless steel bioprocessing units. Along with this, the deployment of single-use systems improves the productivity of biotech companies in the long run as processes regarding cleaning, sterilizing, and validating are either completely omitted or simplified. This not only boosts the efficiency of the enterprise, but also brings down the operational, maintenance, and repair costs. Moreover, the use of single-use bioprocessing units eliminates the expenses required for employing labor to perform these complicated activities.

The flexibility and scalability offered by single-use bioprocessing units aid companies in significantly improving their profit margins. These systems can be scaled, configured, or reconfigured to perform different tasks and match the dynamic supply-demand changes in biomedical production. The overall time required for start-up, validation, and changeover is reduced substantially since sterilization and cleaning procedures are eliminated.

Heavy investments by top businesses broadening the scope of the industry

Prominent healthcare and pharmaceutical companies such as Merck have been actively engaged in R&D activities to develop new products and open new avenues for growth in the sector. Recently, in April 2023, the German science and technology company unveiled its Ultimus® Single-Use Process Container Film. The product features a proprietary woven nylon structure to provide durability and flexibility to biomanufacturers. Moreover, the single-use material offers protection against tears, leaks, and abrasions which makes it an ideal solution for bioprocessing liquid applications.

Similarly, in September 2023, Getinge, a leading healthcare company, announced the launch of AppliFlex ST GMP, a single-use bioreactor designed specifically for clinical cell and gene therapies. Sean Herdlein, VP of the Bioprocessing Department at Getinge highlighted that the product is available in different sizes and offers a holistic cGMP manufacturing solution for researchers and producers. The company has been active in this single-use bioprocessing industry for the past 40 years and has made huge investments in advanced technologies and medical innovations to cater to the demands of its customer base comprehensively.

On the other hand, SaniSure, a major biomanufacturing company, launched its Fill4Sure™ single-use filling assembly technology in April 2024. The solution has been developed to accelerate drug product-filling processes and improve the efficiency and security of the repetitive tasks involved in these activities. It features high-performance tubing, low-particulate 2D surge bags, adhesive-free OEM and custom-designed needles, and silicone over-molding to ensure the purity and integrity of the drug. Such ingenious product launches are expected to help the company improve its revenue share in the company and expand the scope of the industry in the coming period.

In summary, the single-use bioprocessing market is anticipated to grow at an exponential rate in the near future on account of the rising applicability of advanced materials in biomanufacturing applications. Furthermore, the various advantages offered by these systems are predicted to impact the industry positively.

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