White Paper

Biomanufacturing Complexity

Source: BIO-G

Biopharmaceutical manufacturing is characterized by significant, and at times overwhelming, complexity, from the intricacies of the technology itself to the need to understand many interacting processes and systems. Biotech facilities also have unique challenges not seen in any other industry. It is a constant struggle to remain
flexible under the constrictions of GxP validation and heavy industry regulation.

In this complex environment, seemingly minor changes can have massive impacts on facility utilization, utilities consumption, variability and risk of contamination. In this whitepaper, we discuss ways of modeling the complete system and, as a result, managing complexity in biomanufacturing facilities. Modeling can be used by your organization to find bottlenecks, increase throughput, lower risk, and accurately understand outcomes that can be expected from process changes.

Biopharmaceutical manufacturing is a fundamentally different paradigm from other high technology manufacturing industries. While other industries also have to cope with yield and manufacturing variability, much of this variability can be engineered or designed out of the process. Biopharmaceutical manufacturing, on the other hand, uses living organisms to grow target molecules. Those living organisms are imperfectly understood, as are the exact conditions they require for optimal growth. This means that variability is inherent to the biomanufacturing
process. That variability needs to be completely envisaged if bottlenecks are to be found and throughput and other metrics are to be improved.