Smart Biomanufacturing: next-generation biopharmaceutical production
Data-driven processes can make biopharma solutions not only smarter, but more agile and reliable as well
Next generation smart biomanufacturing is driven by three key topics: personalization, modularization and digitalization. There is an increasing reliance on small-scale production lines for advanced therapies or for flexible clinical manufacture. Single-use and flexible components drastically increase efficiency and speed of a production line, whilst ensuring product quality. However, such processes need the matching, flexible and intelligent automation technology to ensure right-first-time quality and ease of operation.
Creating insights for smarter processesTo improve yield, reduce time to market and facilitate process validation, Smart Biomanufacturing processes must deliver insights into biological behavior as well as process and product quality. Digitalization enables a deep process understanding for continuous, real-time quality control.
Integrated flexibility and quality for right-first-time production
The automation and IT systems in smart bioprocesses need to be able to cope with two principle challenges:
Firstly, small-scale and single-use processes often use mobile equipment that can be used in several locations. They are set up for a process by combining units in a “plug and play” environment, with flexible numbers and types of sensors and actuators. This necessitates a flexible, plug-and-play automation system with advanced tracking options and a highly intuitive operator interface.
Secondly, technology is increasingly used to monitor and evaluate product and process quality, often in real time. For example, innovative and cloud-connected process sensors and process analytical technology (PAT) help to directly track microbial production in bioreactors.
Siemens is providing flexible automation systems that are easy to configure, powerful PAT tools that enable process data integration and advanced modelling, as well as proven systems for electronic batch recording. Siemens is therefore helping companies to achieve a deeper process understanding while increasing production flexibility – and help win the race for smarter biomanufacturing.