Smart Biomanufacturing: next-generation biopharma processes
Data-driven processes can make bio API production not only smarter, but more agile and reliable as well.
The race for smart biopharma processes is driven by the emergence of three trends: personalized drugs, often tailored the genome of the patient, as a new treatment option for both rare and widespread diseases; flexibility as a means to make plants smarter and adaptable and finally using digitalization to acquire a deep level of process understanding. The industry increasingly relies on small-scale production lines for both testing and optimizing existing processes and for developing new procedures and performing pilot scale productions. In this context, single-use or disposable components drastically increases 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 challenges. First, small-scale and single-use processes often use mobile equipment that can be used in several locations and is 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.
Second, the design and implementation of smart technology as well as direct evaluations of the quality of the resulting products through novel, networked process sensors and process analytical technology (PAT) will help the industry directly track microbial production in bioreactors - still a field where there is much room for improvement.
By providing flexible automation systems that are easy to integrate and set up, including powerful PAT tools to integrate process data with advanced modelling, and proven systems for electronic batch recording, Siemens can help companies achieve a deeper process understanding while increasing production flexibility - and help you win the race for smarter biomanufacturing.
Sartorius automation platform
Sartorius Stedim Biotech (SSB), a leading supplier for the biopharmaceutical industry, will preferably use Siemens automation technologies in the future.
Here hardware and software components will be employed in many products and solutions that SSB offers its customers for the development and manufacture of biopharmaceuticals, such as vaccines and monoclonal antibodies.
Right now single-use manufacturing has a lot of manual steps. With the new automation platform those manual steps should be covered and turned into a really automated process, as flexible manufacturing calls for flexible automation.
The result: higher efficiency, quality and flexibility, as well as faster time to market.
Find further information in the joint Press Release by Siemens and Sartorius Stedim Biotech GmbH.