By Gareth Macdonald
Demand for real-time access to manufacturing data is driving the adoption of digital bioprocessing technology in the contracting space. The biopharmaceutical industry is usually slow to embrace new technologies because the rules covering manufacturing are strict and changes to approved production processes need to be verified. The amount of regulatory work such verification creates is significant and can put firms off.
But contractors are the exception. CDMOs are “early adopters,” according to Rob Perry, senior director of manufacturing engineering for Thermo Fisher’s Pharma Services business, who says that in the services sector, customer demand is the key driver.
“Customers want to understand the technologies we are using. They want to ensure they will have quick access to their data and that we are using the best technologies to create the highest quality products in the most efficient way possible. Today, we see our digital technologies as a differentiator, while we also know the industry is moving quickly on this front,” Perry says.
So CDMOs are adopting digital technologies to meet customer demand. But there are other pluses of using bioprocessing systems that gather process data in real time.
According to Perry, “There are numerous benefits. Digital technology will reduce paper on the shop floor. That helps with reducing documentation errors, improving productivity, and better visibility of manufacturing performance. It removes process inefficiencies and could, therefore, improve our ability to expand capacity more quickly than through traditional capital expenditure investments.
Stronger training programs
Digital supports stronger training programs as well as removing barriers like access to information needed to make good decisions.”
“We are investing in manufacturing equipment that is digitally driven and connected as well as an infrastructure that allows better accessibility and control,” he continues.
Staff development is another factor, notes Perry, who says helping engineering gain the skills needed to use new systems has numerous benefits.
“We are improving the operator experience by bringing augmented and virtual reality tools into training programs, and to support activities on the shop floor. We also can provide virtual tours of our facilities, which was a particularly big help during COVID-19,” he explains. “Maybe most importantly, we are investing in our people by increasing their capabilities around digital technology and creating value for the organization with the data the technology collects.”
Ultimately whether a CDMO invests in a particular technology will depend on the benefits it can derive, adds Perry, citing artificial intelligence-based systems as an example.
“While AI technology is currently ahead of the regulatory guidance on the topic, regulatory agencies are working with industry to help manage this. Technology moves quickly so lifecycle management of it can be challenging. And there’s a lot of technology out there so organizations need to make sure they adopt those that will bring their company the best value.”