Biopharmaceuticals have swiftly risen to great heights in the world of medicine, and it’s clear that they are here to stay. These life-saving drugs offer high efficacy and fewer side effects for many disease conditions and generated more than $275 billion last year in global revenue.1 But on the flipside, making these biological molecules is not simple – they are constantly evolving, with sophisticated structures that beget an equally complex set of operational and technological challenges. In tackling these challenges and achieving long-term manufacturing success, it’s important to establish an optimized production process and outcome.
In this article, we take a look at how the process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods. For a successful optimization, the teams managing the process must have a good understanding of its various elements and how they can be augmented to support an enhanced outcome. For example, things like streamlining operations, optimizing titers and yields, evaluating cell lines and cell culture media, and controlling raw material variability can play a pivotal role in obtaining a highly purified, safe, efficacious, and cost-effective product.