Bioprocess Technology Working Group

We want to build bridges between the “omics” sciences, process development and scale up for industrially relevant processes for biopharmaceuticals, secondary metabolites and renewable energies 

                                                          GOALS

The Research and Development Vision of our group is the

Method development for efficient and scientifically based bioprocess development

Research Motivation:

Paradigm-Change: Pushing for more scientifically based processes

FDA actively supports the development of a „Design Space“, in which process may vary without additional approval anlong Quality by Design (QbD) principles. Real time Assessment via Process Analytical Technology (PAT) of single unit operations may replace batch release on final product specification (ICH Q8)

On-line, In-line and At-line Sensors are now available for the measurement of multiple compound

• Photometric and chromatographic methods
• Non-Invasive methods

Algorithms for data reduction are in place

• Quick data treatment allows on-line exploitation
• Multivariate Data Analysis (e.g. PCA)
• Knowledge Based Methods (Neural Networks)

Data-generation and scientifically based exploitation must also be possible in industrial scale!

Motivation Summary

Scientifically based process development enters regulatory constraints:

• Regulatory framework set
• On-line Sensors and exploitation methods can be provided, for process development as well as for industrial scale

Bioprocess Engineers to act 

• Build interdisciplinary bridges
• Develop exploitation tools
• Integrate tools, methods, systems and biological know-how

The important aspect in developing process understanding is the transformation of data into information and further into knowledge.