The Bioprocessing 4.0 concept seeks to apply automation and technology to the digital transformation of biologics manufacturing. As the paradigm moves forward, it faces barriers to its adoption, according to Eric Langer, president of BioPlan Associates. “Perhaps the greatest challenges involve unsecured links and adapting the applications to areas where automation is critically needed today,” says Langer. “Unresolved security issues could seriously affect a company’s data in a regulated environment, so they will need to have iron-clad anti-hacking protection in place. Unfortunately, cyber security is not yet a top focus for the industry.”
Langer sees the biotech mindset as quite different from that which pervades Silicon Valley. “In the computer industry, companies seek to be on the vanguard; but in bioprocessing, where the risk of failure is high, and regulators look harder at novel technologies, few want to be on the cutting edge,” he continues. “So we see a lot of laggards on the new technology adoption curve. Many feel that if what they have is working, if it is good enough, they don’t feel the necessity for radical change.”
This is of course understandable as a failure in a system that regulates the lights in your house may have trivial consequences, but a bioprocessing program that fails to flag a dangerous drug would be catastrophic.
“Today we see important developments on the horizon, such as predictive programming, that will enable the introduction of technologies that people may not be explicitly demanding. But bear in mind that before they were introduced, nobody felt they needed a smart phone, either,” notes Langer. “So somebody has to be the first to demonstrate to regulators that technologies such as off-site monitoring can be sufficiently secure as to guarantee the quality of their drug product.”
From his interactions with people in the industry, Langer observes that while off-site monitoring technology is moving ahead, the industry has been relatively slow to adopt it, and needs to have safeguards in place, with a track record that isn’t yet available.
“Cell therapy operations, for example, could be a challenge with multiple sites. Although the specific IT applications that are being created today may not be exactly what is needed, what is being developed will likely establish a foundation and path forward,” he says. “These next generation systems such as compute file processing, lab information management, and clean room automation will be just some of the applications requiring Bioprocessing 4.0 in the future. I think we can be confident that the industry is building the infrastructure today for which there may not at present be a crystal-clear need, but when they are developed, applications for these new technologies will be found.”