Vocabulary Chemical Engineering in Pharma
A quiet revolution is occurring in the pharma industry where now chemical engineering methods are introduced in research, design, development, and implementations by many pharmaceutical companies. This quiet revolution is due to the fact that regulatory bodies such as the FDA play an active role in this [1], and that process technology providers develop process designs fitting to the specific pharma needs, such as ZETON [2].
Here is a vocabulary of terms used in this new field:
Flow chemistry
Flow chemistry means continuous processing (rather than batch processing) for a new medicine or Active Pharma Ingredient (API). Often it means, in addition, that process intensified technologies are used. Outside pharma the term is also used by some university researchers when researching process intensified small process equipment.
Scale-up
The scale-up term used in the pharma industry means product scale-up. It means that in several phases more of the new medicine is produced for specific tests. The specified pharma phases are discovery, pre-clinical, clinical phase I, clinical phase II, Clinical phase III, Approval, and finally manufacturing [3] . When someone want to talk about new process development in a pharma environment it is better to avoid for that specific activity the word scale-up, otherwise confusion may start.
Quantitative System Pharmacology (QSP)
Quantitative System Pharmacology means that chemical engineering methods and practices are applied in pharmaceutical companies to rapidly find new medicines for specific diseases [4].
The two main methods applied are.
- Chemical reaction engineering concepts and models to generate medicine options
- Designing, constructing, and testing with physical analogues, using chemical engineering principles such as hydrodynamics, mass transfer and reaction.
The physical analogue can contain an analogue of the human body, such as the lungs, and contain the medicine admission technique, such as an inhaler.
References
[1] Lee SL. Current FDA perspective for continuous manufacturing. In2nd International Symposium on Continuous Manufacturing of Pharmaceuticals, Cambridge, USA, 2016 Sep 26.
[2] ZETON, pharma-biotech plants for continuous manufacturing of Active Pharmaceutical Ingredients (API), sourced 222 Nov. 2022, https://www.zeton.com/industries/pharma-biotech/
[3] Kahn A. Phase-appropriate formulation and process design, Pharmaceut. Techn.40 (1) 42-45, 2016.
[4] Cesar Pichardo of Astra Zeneca and Roberto Abbiati of Boehringer Ingelheim, presentations, Chemical Engineering as applied to Medicine, EFCE forum meeting, Paris, 5th of December 2022.