A growing bulk of this demand comes from biologics which have become the mainstay of treatment methods from cancer to autoimmune disorder to viral infections. For 25% of the world’s R&D companies headquartered in APAC, this trend has implications for manufacturing and process design.[2]   It has become imperative, now more than ever, for the industry turn to sustainable practices.

Estimates suggest that 80% of existing production infrastructure is unable to support 80% of drugs in development. Since 2021, a vast majority of drugs in development are produced between 100kg –500 kg per year, up from less than 150 kg just a decade ago.  This change has highlighted the need for scalable production processes, paving the way for single-use technology (SUT), flexible manufacturing, and modular facilities.

As a global provider of technologies and services for the development, manufacture and delivery of therapeutics, Cytiva ensures that environmental sustainability remains at the forefront of these technologies and processes for the biopharmaceuticals industry.

The benefits of SUT in biomanufacturing

Aside from its adoption in supply chains, configurable plastics-based single-use technology (SUT) products allow biopharmaceutical companies to execute safe and secure multi-batch and multi-drug production. This in turn, provides companies with the agility to expand global manufacturing operations when needed.

Plastic use comes at a great cost to the environment, and remains a priority area for the biopharma industry, where it is used not just in packaging and shipping but also in production through SUT. Cytiva is adopting a circular approach by working across the supply chain on recycling and safe waste-management solutions. By 2025, we are targeting 50% of single-use products and components to be widely acceptable for recycling or through an accessible recycling stream.

Notably, a 2022 study published in New Biotechnology by Budzinski et al on the life cycle of a biomanufacturing process utilizing SUT shows that across all impact categories, the contribution to the environmental footprint is minimal.[3]  The study also revealed that the largest contribution to the life-cycle environmental impact is the electricity needed for operations.

Therefore, to address the environmental impact of biomanufacturing more comprehensively, we are looking beyond SUT.

Agile manufacturing to reduce environmental impact

In the aforementioned study, operational changes are nominated as one of the best strategies to reduce the life-cycle environmental impact of biomanufacturing, as they can increase process efficiency and reduce delivery time.[1]

To increase process efficiency and save time in manufacturing, biopharma companies need to get the process and facility design right the first time. This means that the equipment should be flexible enough to suit production of individual products through a single-use flow path that can be sized accordingly.

At Cytiva, our enterprise solutions, consisting of FlexFactory  and KuBio production platforms and process design services, provide customers with options to achieve their goals at every level of biomanufacturing — process, capacity, equipment, automation, and human competencies.

FlexFactory is our scalable, integrated upstream and downstream single-use or hybrid platform. It gives customers rapid access to a cGMP manufacturing capacity while providing flexibility in their production process when their needs change.

KUBio is our cGMP-compliant process and prefabricated facility solution for monoclonal antibody production. With KUBio, biopharmaceutical companies can be operational in just 18 months, instead of 3-5 years and at a fraction of the cost of a non-prefabricated setup. Solutions such as KuBio and FlexFactory not only save companies time but also reduces resource wastage.

Sustainability through the value chain

A key effort in improving sustainability is reviewing our supply chain including our own manufacturing standards, our supply sources and vendor criteria to promote the reduction of carbon emissions.  This means that the responsibility doesn’t just rest on a single company but on every organisation within the entire value chain.

If the biopharma industry adopts more agile ways of operations and careful planning of biomanufacturing process at the pre-clinical, clinical and commercial stages, we will be one step closer to a sustainable future.

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[1] “Biologic Therapeutic Drugs: Technologies and Global Markets.” https://www.bccresearch.com/market-research/biotechnology/biologic-therapeutic-drugs-technologies-markets-report.html.

[2] “Pharma R&D Annual Review 2021: Navigating the Landscape,” p20. https://pharmaintelligence.informa.com/~/media/informa-shop-window/pharma/2021/pharmaprojects_jp/pharma-rd-annual-review-2022_lr_rvsd_en_final.pdf.

[3] “Streamlined life cycle assessment of single use technologies in biopharmaceutical manufacture.”  https://www.sciencedirect.com/science/article/pii/S1871678422000024#bib0080