Competition is driving innovation in monoclonal antibody manufacturing, say researchers, who predict that single-use technology will play an even greater role in production in years to come. Johnson & Johnson’s immunosuppressant Orthoclone OKT3 established the commercial monoclonal antibody market in 1986 when it gained FDA approval for the prevention of rejection in kidney transplant patients.

In the decades since more than 100 mAbs have been approved. Manufacturing methods have matured, and industry has established reliable, consistent production processes. But manufacturing methods can still improve, notes Jessica Whelan, PhD, assistant professor at University of Dublin’s school of chemical and bioprocess engineering, who says competition has rekindled innovation.

“mAb biomanufacturing processes are relatively mature. The current challenges facing the industry are primarily focused on cost reduction to address increased competition from biosimilars, accelerating time to market for new products, and increasing the level of flexibility and agility in manufacture to cope with increased numbers of products with typically lower volumes required,” she tells GEN.

Whelan’s take is in keeping with analysis by McKinsey, which suggested the global biosimilars market is undergoing “monumental growth” and will be worth $60 billion a year by the end of the decade, up from $20 billion in 2020.

Improvements

Efforts to reduce costs will need to be wide-ranging, according to Whelan, who says there is room to improve all technologies and reagents used in mAb production.

“Further development of single-use technologies is needed to help address the flexible, multiproduct facility requirement while minimizing downtime and risk of product changeover,” she continues. “Protein A remains the single biggest contributor to the OpEx costs and approaches to either replace Protein A with alternative technologies or increasing efficiency of its use by for example multiproduct reuse are of significant interest.”

And disposable manufacturing technologies are likely to play an even greater role in commercial mAb production, Whelan points out, citing the growth biosimilars market and the increasing number of companion diagnostics entering development as major drivers.

“Over the next 10 years, there will be significant advances in diagnostics to support more targeted treatment of cancers and other conditions. This, in conjunction with greater numbers of biosimilars, will result in a larger number of approved mAb based products on the market with a lower average annual demand,” she explains.

“This will continue to push the industry further towards single use, smaller, more flexible multi-product facilities. The spectrum of mAb products will diversify further to include greater numbers of ADCs, bispecifics, and FAb fragments.”

The industry is also embracing innovative technologies, says Susan McDonnell, PhD, professor, University of Dublin, and Whelan’s co-author on a study examining the use of emerging technologies in mAb production, and cites automation as an example.

“Automation enables a reduction in the labor required in addition to alleviating human error as a source of deviation from the GMP manufacturing process. It increases the level of reproducibility achievable in these inherently complex and variable bioprocesses,” according to McDonnell.

“Data analytics and approaches such as AI, machine learning, etc., are of growing interest in the sector as they are key to enabling Industry 4.0. For example, multivariate data-based process models can be used to predict and prevent unwanted process issues through the real-time monitoring of plant performance against the desired/expected, also known as the ‘golden batch’ in these instances.”

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