Automation in downstream bio processing
The development of biotherapeutics is evolving with advancements in equipment, automation, and process optimization. As biotherapeutic modalities become more complex, manufacturing trends must adapt to maintain efficiency and scalability. Different experts discuss the various challenges and advances.
Smriti Khera, PhD, global head of life sciences strategy and marketing at Rockwell Automation mentions some important categories of challenges. “For one, in bioprocess development today, more than ever, there is a need for bioprocesses to be well aligned with the manufacturing supply chain and distribution strategy that is intended for that product right from the get-go,” she says.
Small-scale versus large-scale
Furthermore Khera mentions two parallel but opposing megatrends. On the one hand there is large-scale drug production which focuses on increasing yield and efficiency through automation, digital twins, and process analytical technology (PAT).
On the other hand, precision medicines like cell and gene therapies (CGTs) require customized small-scale manufacturing with strict logistics. Patients can be anywhere on the globe and need a fast delivery.
The more traditional challenges in bioprocess development are around determining and monitoring set points for critical process parameters (CPPs) and critical quality attributes (CQAs). CPPs can be dramatically different at different scales, so maintaining conditions correctly, such as homogeneity, temperature, and dissolved oxygen, can be very different at different scales and must be monitored. This can be very labor-intensive. There’s a big opportunity for using advanced data-driven models and machine learning (ML) to optimize process conditions and reducing manual experimentation.
Single-use technologies
Anthony Christopher, commercial manager of bioprocessing at Kent Elastomer Products (KEP) emphasizes that one of the most prominent recent developments in the biomanufacturing space is the increased adoption of single-use technologies (SUTs). It can help reduce contamination risks, streamline cleaning requirements, and enable faster changeovers. Other evolutions that are becoming more prevalent are continuous manufacturing, modular production units, and integrated analytics. Automation technologies, such as digital twins, automated sampling, and smart bioreactors, enhance efficiency and monitoring, though full automation remains rare.
Scaling up with automation
Integrating automation into biomanufacturing enables a smoother transition from process development to GMP production. Standardized platforms help avoid costly reprogramming and retraining. Companies like Cytiva are leveraging simulation tools and automation libraries to optimize production, while PAT technologies improve real-time quality monitoring. “PAT enhances monitoring at “moments of truth,” where critical control points impact drug quality, safety, and efficacy”, says Nicolas Pivet vice-president of Cytiva. “Integration with manufacturing execution systems and laboratory information management systems ensures full process visibility.”
Future outlook
Automation, AI, and robotics are driving the industry toward fully automated facilities, but challenges such as cost and regulatory compliance remain. Experts predict that "lights-out" biomanufacturing—fully autonomous production—could become a reality within the next 5–10 years.
Source: https://www.biopharminternational.com/view/progressing-toward-full-automation-in-biomanufacturing