Deep Dive into Biopharmaceutical Analysis
Advanced tools across a number of analytical techniques are helping medicine makers better understand their biomolecules – ensuring both safety and efficacy.
Stephanie Sutton |
Why is deep biopharma characterization so important for the discovery, development, and manufacture of new biologic drugs?
Anurag Rathore: The importance, as well as significance, of characterization for biopharma arises from the complexity of the product. Biotherapeutics are complex nano-machines, designed to work at a specific rate, for a specific function. This specificity can only be assured if all the parts of the nano-machines are intact and aligned accurately. For this, it is important to first understand how different stresses impact the assembly. Moreover, as it is a product used in bulk (millions of molecules per dose), the range of contaminants and their effect on product function will vary.
Characterization helps define all of the above features in minute detail – and this understanding can then be used in all aspects of development and manufacturing as a signature of the molecule’s behavior. In the drug discovery phase, anomalies identified during characterization of a biotherapeutic for a certain target might also help identify treatments for other disorders. Characterization to some extent also helps understand and manage the risk involved with manufacturing, and can help alleviate the cost attached to clinical trials. In my opinion, there are very few industries where quality of the product matters so much to the consumers.
Ultimately, regulation of this quality comes down to efficient and accurate characterization.
Koen Sandra: Anurag summed that up very nicely. Biopharmaceutical products come with enormous structural complexity. The molecules are large (monoclonal antibodies have a molecular weight of 150,000 Da) and heterogeneous as a result of the biosynthetic process and subsequent manufacturing steps and final storage. Despite the fact that typically only one product is cloned, the final drug substance or drug product is composed of a mixture of hundreds of variants that differ in post-translational modifications and higher order structure. These different variants can have an impact on function, stability, efficacy, as well as safety. During development, these characteristics need to be determined in great detail using state-of-the-art methodologies and closely monitored prior to clinical or commercial release. For that, a wide range of analytical techniques and methodologies must be used.
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