EXCLUSIVE: Vaccine development made easy with single-use bioprocessing systems

December 20, 2021
Narayana Rao,

Global solutions provider Avantor has stepped up its single-use biomanufacturing footprint by 30% to include novel cell and gene therapies, as well as vaccines for COVID-19. Single-use bioprocessing systems are much sought after for their ease of use, cost-efficiency, flexibility, and sustainability – Narayana Rao, Avantor’s Vice President, Biopharma for AMEA, explains further about single-use systems in a recent interview with Healthcare Asia (HCA).

HCA: Briefly explain single-use bioprocessing systems and how they are relevant to healthcare – how are they tied to vaccines?
Nara: In recent years, the demand for single-use systems has grown exponentially into a thriving market. Single-use assemblies are designed to be plug-and-play disposable systems, as compared to traditional stainless-steel equipment, which often requires laborious cleaning and cleaning-related validations. With the rapid speed and efficiency needed to create novel vaccines, including mRNA, DNA, and viral vectors, single-use solutions provide the needed flexibility required to develop COVID-19 therapies.

Investments in single-use systems will also support growing customer demand for monoclonal antibodies (mAbs), novel cell and gene therapies for oncology and other diseases, as well as vaccines.

EXCLUSIVE: Vaccine development made easy with single-use bioprocessing systems

To cater to the critical requirements of our customers, our team at Avantor designed and manufactured complex single-use assemblies with multiple components from various suppliers. This included products such as tubing that could withstand 48 hours of continuous operation with filling needles and various makes of pre-sterile and redundant filters in the same line to provide most optimal performance. There were also many instances where we transported assets overnight to ensure our customer’s single-use equipment needs were met.

HCA: Please explain the global advent of single-use bioprocessing systems and its revolutionary benefits.

Nara: The shift to single-use products has allowed for benefits such as improved batch turn-around times, reduced risk of product cross-contamination, and greater sustainability with less water and steam being used than more traditional bioproduction methods. Single-use technologies are more flexible as well as quicker to set up at a lower cost than traditional stainless-steel equipment.

The global single-use bioprocessing market is expected to reach US$20.8 billion by 2026 from US$8.2 billion in 2021, at a growth rate of 20.5% during the forecast period, noted a market research report by Markets and Markets (2021). According to market research and consulting company Grand View Research, which features thousands of statistics and in-depth analysis on 46 industries in 25 major countries worldwide, the global single-use bioprocessing market size is also expected to reach US$33 billion by 2027.

HCA: Asia Pacific (APAC)’s key role in the future of single-use manufacturing?

Nara: The Asia-Pacific region has grown exponentially alongside the growing global single-use bioprocessing market. The Asia-Pacific market for single-use bioprocessing systems, which stood at US$495 million in 2015 according to the European Pharmaceutical Review (2019), is expected to grow by 12.5% by 2024 with a value of US$1,417.2 million by the end of 2024.

China is a high-potential market for single-use systems, closely followed by India, due to strong government support, rising private investments, the growing trend of outsourcing to emerging Asian markets, and the presence of a skilled workforce, according to a report by Markets and Markets (2021).

Avantor is tapping into that growth potential as well. This year, we acquired RIM Bio, a leading China-based manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical manufacturing applications in Changzhou, China. The facility provides a complete range of 2D bags, 3D bags, tank liners, bag assemblies and multi-bag manifolds used in the manufacturing of biologics, vaccines, and advanced therapies. This will be our first Asian single-use facility and will help boost its global capabilities and capacity on the back of continued demand, as well as capture long-term opportunities in the growing AMEA bioproduction space.

HCA: Please explain about the challenges and opportunities for biopharmaceuticals to break into the single-use bioprocessing market.

Nara: Adapting to single-use hybrid production strategies will provide the critical flexibility, speed, and cost reduction required to support the growth of COVID-19 therapeutics. Single-use systems are also now used for roughly 85% of precommercial scale (preclinical and clinical). The commercial scale up of these systems will certainly add to increased demand for these systems in the future.

With the rapid growth of single-use systems by drug manufacturers with multiple locations across the globe, there are also many risks associated with underestimating the regulatory compliance, manufacturing, and quality requirements of these systems. For example, using single-use systems introduces new logistics challenges that, if not properly understood and planned for, can leave biopharma manufacturers vulnerable to supply chain complexities.

To minimise these risks, biopharma manufacturers can benefit by adopting a global single-use supply chain strategy early in the drug development life cycle and carefully evaluate their chosen single-use equipment and materials suppliers. When reviewing a prospective supplier, there are two primary considerations for biopharma manufacturers to keep in mind: the regulatory and quality compliance of the supplier as well the operational excellence of a supplier’s supply chain. Avantor prides itself on our focus and attention to its quality and regulatory systems as well as our global supply chain footprint that allows us to serve our customers globally.

Category: Features, Top Story

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