Bioprocessing analytics is so complex that even PhD-level scientists may not have the skills they need to use certain monitoring and analysis instruments required for bioprocess development and bioprocessing. Recognizing this, developers are working to democratize their tools so they can be used more easily by everyone who needs them at the point of need.
As a tool developer, “our mission is to make analytical tools easily accessible so the bioprocess scientists developing processes can perform key analysis themselves,” rather than having to hand off analyses to other labs, Graziella Piras, a senior director at 908 Devices, tells GEN.
The benefits for biomanufacturers accrue in the form of accelerated processes, lower analytical costs, and process intensification, culminating in reduced time to market.
For example, 908 Devices’ Rebel at-line cell culture media analysis device claims to reduce analytical process time from the conventional three to six weeks to 12 minutes. In the biopharma industry, such time savings add up to major money savings.
“One month of process development costs approximately $1 million,” Piras said, citing a 2020 study by University College London and AstraZeneca.
That study showed that to achieve an overall 12% approval rate for Phase I drugs, for material preparation alone, a biopharma company should expect to spend about $60 million from preclinical to Phase II and about $70 million for Phase III to regulatory review. For a 4 percent success rate—like that of drugs targeting Alzheimer’s disease—the costs increase 2.5-fold.
Therefore, she said, “If you can save a couple of weeks’ time, it matters.”
Real-time analysis matters
On the biomanufacturing side, the focus is on maintaining drug quality and efficacy. “We’re talking about living cells,” she stresses. Anything less than optimal conditions can reduce the quantity of drug produced. Even a small reduction can have “a huge effect on the cost of goods.”
To manage that, Piras advises real-time monitoring and analysis to pinpoint where and when optimal parameters vary, and to enable near-real-time responses. When Terumo Blood and Cell Technologies (a client of 908 Devices) implemented real-time monitoring to control glucose and lactate concentrations in cell cultures, sampling data points increased from one or two per day to as many as 720 per day, thereby providing deeper insights into the process. The risk of contamination also was reduced by eliminating the need for manual sampling.
It’s important for process specialists to not only have the data in real-time, but also to have the interpretation of that data immediately, she points out.
The challenge, Piras says, is that, “the industry is slow to adopt innovative solutions. In that regard, biopharma companies have a fear of being first. They are risk averse.”
That’s natural in highly regulated industries, but regulators, she points out—including the FDA—are eager to work with companies. The FDA wants to help developers adopt platforms that enhance development and manufacturing efficiency and improve drug safety and efficacy.
To reduce the risks, Piras advocates becoming involved in consortia, like NIIMBL, that bring together industry, academia, and innovative tool developers. By collaborating early on, they can advance biomanufacturing innovation.
