“Adoption of continuous perfusion operations, for example, has shown increases in productivity, but to realize the benefits of the upstream gains, the downstream unit operations must keep pace with the increased mass of protein being produced from the bioreactor. Connectivity of the upstream and downstream without interruption will maximize benefits. This requires robust process, analytics, and automation technologies to quickly adjust the process on demand,“ Merrilee Whitney, head of the BioContinuum platform, Merck, told BioPharma-Reporter.
How deeply entrenched are continuous processes currently in biopharma manufacturing, and what is behind this trend?
“We are seeing a rise in the adoption of continuous processing steps in the biopharmaceutical manufacturing sector such as perfusion, multi-column chromatography and flow through polishing,” she remarked.
Merck, continued Whitney, expects to see this trend expand as regulatory acceptance increases and technology to control and automate connected unit operations evolves. “The evolution of process and data analytics with machine learning (ML) and artificial intelligence (AI) will drive advancements in digital maturity and the reality of fully digital and adaptive manufacturing facilities towards ‘lights out’ manufacturing.”
Centralizing management processes
In terms of what she sees as the biggest bottleneck in the biopharmaceuticals production process today and how Merck’s centralized viewing platform, Orchestrator, can address such challenges, Whitney said: