Innovation in the drug R&D lab prompts bioprocessing technology innovation, according to experts who say the cell and gene therapy and antibody drug conjugates (ADC) sector demand for better, faster production systems is the key dynamic.
The cell and gene therapy market is expected to grow significantly over the next decade. Deloitte recently predicted such products will generate revenues of $12 billion a year by 2025, which is an impressive jump for a market valued at just $1 billion three years ago.
Deloitte said the prediction was based on the high level of activity in cell and gene therapy R&D—more than 1,000 clinical trials were ongoing in 2019—and the large number of developers entering the space.
ADCs are also poised for growth according to analysis by Clarivate. The analysts pointed to recent approvals—six of the 11 ADCs on the market have been cleared since 2019—and demand for cancer drugs to support their forecast.
Whether either of these growth predictions pan out will depend on biopharma’s ability to manufacture the products efficiently, according to Travis Whitfill, a partner at biotech venture capital firm Bios Partners, who says new bioprocessing technologies are needed.
“The major innovation happening in manufacturing in my opinion is in cell and gene therapy and more complicated biological products which are increasing the use of single-use systems and in-line processing,” he tells GEN.
This view is shared by Nitin Naik, healthcare and life sciences global business leader at Frost & Sullivan, who notes, “The need to launch innovative therapies, such as cell and gene therapies or mAb combination therapies, faster and at lower cost has pushed industry to innovate. The ability to step up manufacturing in terms of its productivity and scale up across global sites is critical.”
Outsourcing
In the small-molecule and traditional biologics sectors the predominant way of increasing scale and accelerating product development has been to outsource production. And outsourcing is also used in the cell and gene therapy space, according to Whitfill.
“There’s an increasing tendency to outsource because biopharma companies have limited personnel that are very costly, so in many cases, they would like to reallocate those resources to other activities like R&D instead of manufacturing,” he explains.
However, cell and gene therapy production are more complex than small-molecule drug production, particularly in terms of achieving consistency. As a result, it is important that developers looking to outsource to CDMOs also work with technology suppliers to make sure production is consistent, Naik says, adding that “Technology suppliers have a big role to play to influence biopharmaceutical companies in adopting process simplification mind set. Suppliers are leveraging advanced materials or analytical tools to expand bioprocessing applications to a wide range of conditions and improve portability of the processes.”
AI-based production processes are an example. According to Naik, “There are several proof-of-concepts using AI and machine learning that have demonstrated reductions in manufacturing cost or higher productivity.
“However, these approaches rely on consistent equipment performance and access to sophisticated process analytical tools. Equipment performance variation across global sites remains a challenge and so does integration. So, platform ability is the biggest barrier.”
