Biopharmaceuticals are becoming a core aspect of the pharmaceutical industry. These recombinantly produced therapeutic macromolecules currently account for 25% of the total pharmaceutical market (Walsh, 2018, Nature Biotechnology) and are today considered the fastest growing class of therapeutics. Their success is driven by their efficacy in disease areas with a high unmet medical need such as oncology and autoimmune diseases.
However, with an immense therapeutic potential comes an equally great structural complexity. Protein biopharmaceuticals are large molecules (a typical mAb is around 150,000 Da) and as a result of the biosynthetic process and subsequent manufacturing and storage heterogeneous in nature. In addition, the expression systems used to produce these molecules also generate endogenous by-products – such host-cell proteins (HCPs) – which have to be tightly monitored and characterized to ensure final product safety.
Consequently, the in-depth characterization of biopharmaceuticals is highly demanding towards analytics. Particularly this challenge has triggered the creativity of analytical scientists world-wide and has resulted in many innovative tools for studying these ever more complex products.
Tomorrow morning at the 16th HTC meeting in Ghent our CEO, Koen Sandra, will share some of his real-life biopharma experiences and will get you up-to-speed on the hot topics of the industry, like multidimensional liquid chromatography (picture above), micropillar array columns, instrument and column inertness and native mass spectrometry.
Questions after the show? No worries, just walk up to Koen and he will clear up any doubts you may have!