Just before the Christmas break, Lars, Haneskog, Bio-Works R&D Director, presented a new and proven strategy for downstream processing at the New Horizons in Biologics and Bioprocessing conference. It was met with great interest and several enquiries and, for those that missed it, we asked Dr. Haneskog to give us a brief summary of what was discussed.
Improving downstream bioprocess economy depends on fine-tuning an enormous range of parameters, from culture and harvesting to purification and final polishing. Success depends on the ability to troubleshoot difficulties and identify novel approaches that will boost process efficiency in a cost-effective manner. This is particularly true when high-value chromatography columns are used in the process. Bioburden and cleaning-in-place procedures can reduce column lifetime and capacity, and threaten product quality and yield. An alternative approach that protects these valuable columns is to reverse the first two steps to remove the potentially damaging components of a feedstock before proceeding with highly selective capture followed by polishing. We call this ECP...
Peptide therapeutic agents are enjoying increasing success but they are challenging to produce and, not least, to purify. Purity requirements are, in fact, approaching those for small molecules. Synthesis generates a crude mixture containing failed sequences and chemical variants.
The environmental impact of pharmaceutical R&D and production is considerable. Although the industry is rather conservative and also constrained by regulatory guidelines, there is increasing interest in the implementation of sustainable practices that not only improve corporate social responsibility (CSR) performance but also reduce costs and increase efficiency. This effort is embodied in the concept of Green Chemistry and includes reducing the use of toxic solvents in production and purification, which is a considerable problem. Solutions include recycling and the use of upstream protective columns that remove bioburden to increase the life-cycle of columns used downstream, or even make certain solvent-consuming steps redundant altogether.