Chemical Engineering for pharmaceutical process design and scale-up
I attended the European (Bio)Chemical Engineering Congress (ECCE14, ECAB7) in Berlin 17-21 September 2023 and selected for the parallel sessions the topic ‘Chemical engineering for medicine’. This topic covered about 12 % of all topics, a large increase from previous ECCE conferences. Main chemical engineering methods for medicine production presented were modelling, process design and experimental validation at small scale.
An excellent example of the power of this approach was provided by G. Vile of Politecnico di Milano. He presented a continuous packed bed purification chromatography unit operation consisting of three columns. The lab-scale columns are 10 cm long and 1 cm in diameter. One column is fed with the fresh feed and separates the desired component until the bed is saturated. Then the feed is switched to the second column. The first column is now flushed with a solvent to recover the product. The third column is used to rework some of the solvent. By switching between the three columns continuous operation is obtained. The separation purity and yield are superior to the batch chromatography separation and the waste production (spent solvent) is reduced by a factor 5.
In the lively discussion following his presentation Vile gave further details about his 3 column design. He has a dynamic model by which the lab-scale set-up is designed. That model is also to be used for the commercial scale design. Given that scale-up rules for packed beds are available from literature it implies that scale-up to commercial scale can be rapid from this lab-scale.
In the conference two working parties of the EFCE had organised a three-hour session on chemical engineering for medicine production. The room was quickly filled with 50 people and then the door had to be closed to prevent overcrowding. 13 % of the participants were from industry. In a questionnaire, the most important subject in pharma appeared to be scale-up. Topics covered in the session were: modelling to select formulation chemicals for affinity and shelf life, thermodynamic modelling of physical properties and of process design.
During the conference I met many peers from all over the world. I also visited the de Gruyter book exhibition, where our book ‘Multiphase Reactors’ by Jan Harmsen and René Bos, May 2023 was displayed. Karin Sora, the director, took a picture of the book and me, showing a remarkable colour resemblance.