Have you wondered how some of the leading pharmaceutical and biopharmaceutical manufacturers have developed and tested their COVID-19 vaccine candidates in record time? In a Pharma Manufacturing article, The new requirement to fast-track vaccines, Emerson group president for the Systems and Software business, Jim Nyquist, shares ways in which these feats were accomplished.
A digital transformation was needed to dramatically shrink the typical timeline for vaccine development. Jim opened noting:
…dozens, if not hundreds, of behind-the-scenes technologies and services will be critical to help connect the dots and push the development process forward at rapid speed from end to end. Digital transformation, often taken for granted, is playing a hugely important role to help global pharmaceutical companies move a vaccine from research and development to clinical trial to manufacturing to patient delivery. Digital transformation technologies will turn the typically serial process of a drug’s life cycle into compacted parallel processes leveraging digital automation, turning years into months and months into days.
The traditional process for technology transfer through the development required a new approach.
By providing common building blocks in each development stage, process automation enables the translation and transfer of recipes, process steps, critical quality attributes and critical process parameters across the vaccine’s life cycle.
Managing knowledge throughout the lifecycle is also imperative. It requires:
…a process and knowledge management solution that supports everything from the initial recipe structure and associated material and equipment parameters to its automated integration into the individual site automation systems, as well as the necessary change management tools to ensure appropriate version controls as the data and recipe evolves.
One important technology is digital twin simulations.
For example, a digital twin can help connect experts to design, build and test strategies; virtually train operators for abnormal situations; and develop and test process improvements offline. Real-time modeling software can also provide optimized scheduling to determine the facility’s optimum capacity and automate scheduling to meet that capacity. In addition, cloud engineering will help compress capital project schedules and enable 24/7 engineering work to be globally distributed and remote tested.
During the production process:
…efficient production is essential to reduce batch variability, ensure quality and “right-first-time” production, and perfectly replicate subsequent batches. Releasing the vaccine in real time will require review-by-exception and automated release strategies that ensure everything was manufactured correctly and any deviations were addressed before releasing products.
Read the article for more for other ways to shrink the development lifecycle including real-time scheduling and predictive maintenance, optimizing equipment and material control processes, cold chain tracking throughout the supply chain, electronic production records management and more.
Visit the Control Systems and Software for the Life Sciences Industry section on Emerson.com for more on the technologies, services and solutions to drive a step change in manufacturing performance. You can also connect and interact with other pharmaceutical and biotech industry experts in the Life Sciences group in the Emerson Exchange 365 community.