Automating Upstream Processes Helps Sync Workflows

Automation solutions for upstream bioprocessing have proven to be beneficial, saving labor and time. Automating upstream bioprocesses can also provide a tighter feedback loop for process control and can alleviate the challenges traditionally posed in this stage of biomanufacture.

Ongoing challenges in upstream bioprocessing include maintaining quality control (better control of temperature, humidity, pressure, and other factors influencing quality and cell growth), traceability, and labor savings, says Chris Barnes, strategic account manager, Life Sciences, Omron Automation Americas.

Chris Sandusky, director, Automation Solutions, Cytiva, notes that automation is a large area of study and focus. “If you look at just basic automation of a machine, it allows for the repeatable manufacture of a step or process within defined boundary conditions. When this is applied to upstream bioprocessing, it allows for tighter control of process variables that have an impact on the growth profile of a bioreactor,” he states.

There is also the benefit of knowing that automation ensures that the process is stable and is controlled within the critical process parameter (CPP) boundary limits. “Without automation, the process would need to be manually monitored and controlled,” says Pamela Docherty, life sciences industry manager at Siemens Industry, USA. “Automation is the backbone for data collection. Without automation, data would need to be captured manually, [possibly resulting in] errors and gaps,” she states.

Adopting automation

Automation is being more widely adopted in bioprocessing. It allows for more precise control of process variables to within established boundaries based on a particular step in a process, notes Sandusky, who explains that the process can be rather simple, involving control of the temperature of a vessel, or a bit more complex, involving control of a tank level with a simultaneous inflow and outflow from a vessel. “These process variables can be classified as critical quality attributes (CQAs) or CPPs; they define the acceptable manufacturing ranges for automation, allowing for more accurate and repeatable control of these items than manual control would allow,” he says.

Adoption of automation in upstream bioprocessing is also beneficial to the cell culture environment within the bioreactor. The health (including quality, lifespan), growth, and reproduction rate of cells are dependent on their living environment, Barnes emphasizes; therefore, the precise control of temperature, humidity, pressure, and other conditions are vital. These can be consistently achieved through automated process control. In addition, new artificial intelligence (AI) controllers can aid with process optimization, he states.

All upstream unit operations use automation to varying degrees, says Sandusky. He states that the biggest differentiation with automation is how units interact with each other, such as with automated transfers or manual transfers, and how units are started–either with a manual start or with an automated batch/recipe start. Another area where automation is adopted is with a manufacturing execution system that further documents the process for electronic batch recording, Sandusky adds.

Automation is found on almost all manufacturing scales, adds Docherty, who points out that the market is seeing a spike in the adoption of process analytical technology (PAT). “PAT enables the understanding of parameters that cannot be read through traditional instruments. With more data capture and knowledge gathering we are now able to solve more advanced problems,” she states.

However, the current level of adoption of automation in the biopharma industry can be difficult to assess. “It is a moving target, as automation technologies are rapidly evolving, often faster than the technologies can be adopted and incorporated into processes,” says Barnes. “The time delays of regulatory approvals and long design engineering cycles often mean that a newer technology is available by the time one is implemented.”

What automation does not yet solve

Automation is not yet ubiquitous in bioprocessing. For instance, the loading of consumables remains a typically manual operation, says Sandusky. In addition, the replacement of tube sets and single-use bags are still performed manually. Looking to the future, however, a robotic system would be capable of loading consumables, he notes.

Meanwhile, the knowledge of the scientist remains an area that may not easily adopt automation, although some may argue that, with the advancement in AI, the industry may be approaching that ability, observes Docherty.

Furthermore, Barnes points out that although new AI controllers can help to identify outliers or abnormalities in the process, they cannot identify the root cause, such as whether the cause is contamination or cell mutation.

Biopharma manufacturers can look to fast-evolving automation technologies for new ways to address the constant goal of better quality and more rapid production.

About the author

Feliza Mirasol is the science editor for BioPharm International.

Article Details

BioPharm International
Vol. 35, No. 1
January 2022
Page: 24

Citation

When referring to this article, please cite it as F. Mirasol, “Automating Upstream Processes Helps Sync Workflows,” BioPharm International 35 (1) 24 (2022).