The main objectives of bioprocesses are to reliably deliver drugs in a relatively short time frame with high quality within a tight regulatory framework. Bioprocesses are highly complex, the level of automation is moderate, and there is constant pressure to improve efficiency and costs. In addition, climate change and resource scarcity mandate a reduction in the environmental footprint of bioprocesses and production facilities. In the biopharmaceutical industry, two extreme production scenarios are applied: a fully disposable factory with the characteristics of full flexibility and speed, or a fixed large-scale plant with high capacity. Forward-looking solutions and ideas will be discussed how to combine new processes and environmental friendliness for the benefit of the patient, security of supply and profitability. The concept will be extended to large scale production of proteins for food and non-pharma applications, e.g., in material science and a roadmap towards a future plant will be laid out.

While packed bed chromatography, known as conventional chromatography, has been serving the biopharmaceutical industry for decades as the bioseparation method of choice, alternative approaches are likely to take an increasing leading role in the next few years. The high number of new biological drugs under development, and the need to make biopharmaceuticals widely accessible, has been driving the academia and industry in the quest of anything but conventional chromatography approaches. In this perspective paper, these alternative approaches are discussed in view of current and future challenges in the downstream processing field.