Despite the importance of downstream bioprocessing, there are many opportunities for improvement, according to a report by Alois Jungbauer, PhD, a retired professor of biotechnology at the University of Natural Resources and Life Sciences (BOKU) in Vienna, Austria, and his colleagues.
As these scientists noted: “Downstream processing plays an important role in the supply of pharmaceuticals and, in particular, biopharmaceuticals, where a large proportion of the production costs are attributable to the recovery and purification processes.”
Still, downstream processing impacts more than the cost of biopharmaceuticals. Most important, the safety of a biopharmaceutical depends critically on downstream steps.
“Patient safety is not only determined by the molecular structure, delivery, and dosing of the therapeutic drug product, but is also influenced by possible product variants and impurities that are not removed or controlled to specified levels during downstream processing,” according to the Jungbauer team.
Considering more purification options
Moreover, more options for purification could be considered, especially for certain biopharmaceuticals. As Jungbauer and his colleagues suggested: “New modalities could benefit from expansion of the current toolbox available for downstream purification, for example, new affinity ligands.”
Downstream steps in bioprocessing also offer opportunities to improve the industry’s sustainability. “Keeping in mind the enormous consumption of water during downstream processing, process intensification will have a substantial effect on the reduction of carbon emissions and also on the use of natural resources,” pointed out Jungbauer.
Some ongoing changes already make bioprocessing greener. As an example, Jungbauer and his colleagues explained: “It is evident that single‐use technology will reduce carbon footprint by reduction of water use for cleaning purposes, though at the expense of increased plastic waste, which, in turn, could be upcycled.”
Getting the most improvements from downstream bioprocessing will take teamwork. As Jungbauer and his colleagues concluded: “Industry, academic institutions, suppliers, and regulatory agencies working together can yield state-of-the-art downstream processes and prepare to efficiently deliver future therapeutic modalities.”
