May 5, 2021 CDMOs Embrace Industry 4.0 to Satisfy Customer Demand
As a premium CDMO, our strategy drives us to not only offer exclusive services, but also make digital differentiating capabilities available to our clients. These include data-driven manufacturing elements that are central to the Industry 4.0 approach. The use of “smart” and autonomous systems to enhance the computer control of biopharmaceutical manufacturing are increasingly gaining relevance.
Jadranka Koehn, Senior Director Innovation Partnerships and Wolfram Schulze, VP Information systems and Organization spoke to Genetic Engineering & Biotechnology News about our digital agenda in context of the digitalization of bioprocessing technology.
“There is no doubt that innovative bioprocessing techniques and technologies provide a competitive edge in our sector. This new dimension of digital maturity and capability is becoming increasingly important in the CDMO selection process, and its relevance extends beyond pure bioprocessing technologies. This trend is reflected in the new FDA regulations, where data integrity and process control are two important cornerstones. Regulatory authorities expect us to understand our process and product in its entirety, hence the need for data, especially high-quality data,” said Jadranka Koehn.
She cited digital innovations such as mixed reality (the visualization of real and virtual objects), natural language processing, and context-sensitive human–machine interfaces as examples of technologies helping the CDMO sector to more fully model and control manufacturing processes.
The extra effort and investment in these technologies are worthwhile, advised Wolfram Schulze. Although he acknowledged that the validation steps followed for a traditional process differ from those for an innovative process, he insisted that the result “has to be the same.”
“With more high-quality data available, robust processes can be developed that act as an enabler for early-stage development. Full data integration and modeling enable faster process development than is possible with traditional techniques and technologies. Ultimately, agility, automation, and an iterative incremental approach will not only drive a learning culture, but also provide a safety net of semiautomated processes. This in turn will facilitate transfer of knowledge from the software domain with each successive step, resulting in increased quality,” he said.
Please follow this link to read the entire interview here.
Rentschler Biopharma SE
Dr. Cora Kaiser
Senior Director Corporate Communication