Dr Ralf Eisenhuth , principial scientist , and Dr Philipp Markolin , science marketing specialist , at Bachem , outline a new means of peptide and oligonucleotide API purification
MCSGP : Entering the era of continuous chromatography for large-scale ‘ tides ’ purification
Dr Ralf Eisenhuth , principial scientist , and Dr Philipp Markolin , science marketing specialist , at Bachem , outline a new means of peptide and oligonucleotide API purification
Increased global demand for therapeutic peptides and oligonucleotides , or ‘ tides ', has put formerly niche complex API manufacturers and CDMOs in the focus of pharmaceutical companies . With it came a need for the intensification of production processes and implementing substantially better , cleaner and more efficient technologies .
Historical shift
The intensification of production processes has been a driving force in the 20th century for many manufacturing industries . Shifting from batch-wise production towards continuous processing has been a trend across various sectors , from oil refining to food production to chemicals .
In pharmaceuticals , this evolution is not just a technical upgrade ; it is a strategic overhaul , aligning the evergrowing demand for cost-effective , large-scale production of new drug modalities with the industry ’ s stringent regulatory landscape . Continuous processes tend to increase product quality and are thus in line with quality initiatives from regulatory bodies like the FDA .
While flow chemistry is still far from displacing batch synthesis for most biopharmaceuticals , the last five years have seen a switch towards continuous processes during the chromatographic purification of APIs , including large biopharmaceuticals , such as monoclonal antibodies . 1 , 2
The renaissance in peptide and oligonucleotide therapeutics has further reshaped the pharmaceutical landscape . These large synthetic molecules , with their high specificity and potency , have emerged as vital tools in treating a range of diseases , from metabolic disorders to cancers , immunology and rare diseases .
Propelled by their therapeutic potential , tides manufacturers face the need for more robust and scalable purification processes that can also make a dent into one of the largest challenges of these new drug modalities .
PMI & the Pareto barrier
Due to the complexity of these large synthetic APIs , manufacturing tides is very-resource intensive . Process mass intensity ( PMI ) is one of the metrics used to assess the environmental impact of a manufacturing process calculated
Figure 1 - Contributors to process mass intensity for tides
48 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981