Representatives of the biopharmaceutical industry joined forces to deepen the level of collaboration and competitiveness of operations collectively in what is known as the BioPhorum Operations Group (BPOG), comprising more than 2,060 active participants. The group’s recent technology road mapping mission was completed to accelerate industry innovation by focusing the community, providing direction, resolving critical needs and ensuring technologies are delivered and adopted.
The process is a dynamic and evolving collaborative technology management process for determining precompetitive critical needs and drivers, identifying technology and/or manufacturing targets, assessing/modeling potential solutions and coordinating implementation projects.
“It took a lot of effort and a lot of discussions,” explained Rajesh Beri, technical director, R&D, biomanufacturing, Lonza, who talked about the process and shared its results when he addressed the Life Sciences Forum at Automation Fair in Philadelphia this week. “It was a two-year effort among 37 different organizations. We also brought in supply partners. In July 2017, we published a roadmap, which was 400 pages of content, divided into eight sections.” It had been downloaded more than 5,000 times as of July 2018.
“We did a survey of the people who’d downloaded the roadmap, and 70% of them said they agreed with it,” said Beri.
The roadmap includes the why, the what, and the how of the BPOG vision.
Market trends and business drivers—the why—are cost pressure, the uncertainty of regulatory approvals and competition, market growth and new product classes.
Biotechnology manufacturing scenarios—the what—are defined by five facility types, ranging from high-volume, large-scale batch production to low-volume, small-scale personalized medicines.
The assortment of enabling technologies and capabilities—the how—were in turn sorted into six groups: process technologies, in-line monitoring and real-time release, modular and mobile, automated facility, knowledge management and supply partnership management.
After the roadmap was published, BPOG and the supply partners identified 10 projects addressing needs and categorized them within identified technology groupings.
Continuous downstream processing, buffer preparation and cell harvesting fell under process technology.
Rapid release testing through in-line monitoring and rapid methods for adventitious detection and sterility assurance were classified as in-line monitoring real time and release technologies.
Standard facility design was the sole modular-and-mobile technology identified.
Automated-facility technologies were big data to smart data, robotics and plug-and-play. And knowledge management was identified as a technology.
Robotics, in particular, are of interest to our speaker. Noting that labor is a valuable resource, Beri said the use of robotics allows more efficient use of personnel.
Beri noted that 65% of analysis is done at-line or off-line. And robotic systems are widely used in discovery and in development/QC labs. “The opportunity for robotics was in the good-manufacturing-practice (GMP) areas. Our goal now is to create awareness of collaborative robots.”
The end result of the BPOG road mapping efforts will be a white paper and journal articles. “Just like the robotics project, each of the other nine projects has a charter, and we’ll see how those go,” said Beri. “In two or more years, we will know if our efforts have been successful.”