Industry 4.0 In Biomanufacturing – Implications And Opportunities

By Michael Mühlegger

Biomanufacturing per se is defined as an industrial production using scalable, validated processes that utilize microorganisms and biological systems like animal cells, plant cells or stem cells to develop and produce biomolecules and -materials to use for therapeutics. So while the aim of biomanufacturing companies is to improve the quality of life of humans with the development of ever-new products - from stem cell therapies to genome sequencing and therapeutics - all of which are based on organic microbes, artificial intelligence plays another important role.

Industry 4.0, also known as the fourth industrial revolution, which the biotechnology and bioprocessing industries are currently experiencing as Pharma 4.0, goes to prove the point: The integration of IoT in synthetic biology, is not a new reality. Many biomanufacturing processes have been subjected to digital transformation for years, resulting in improved unit operations as well as an overall favorable track record, while obviously complying with both regulatory requirements and GMP standards. This also goes for single-use technologies, which aim at making supply chains more efficient and reduce product loss by providing specific protective technologies, equipped with Pharma 4.0 mechanisms.

While some newly developed or upgraded industrial applications may still need improvement, in the long run they promise dynamic process optimization and increased levels of agility. At the same time, the increased introduction of single-use technology will allow for more flexibility in terms of seamless adjustments as well as scale-up.