Developing Trends in Biopharma Analysis

In addition to using peptide mapping concepts in Multi-Attribute Methods (MAMs), large biopharmaceutical firms are also using MS-based identity methods to unlock biologic medicines and drug materials.

FREMONT, CA: Efficient analytical methods are essential for the efficient production and commercialization of small and large molecule drug and consumer products. As the complexity of both biological and chemical drug compounds grows, analytical techniques must also change.

The most notable developments in analytical approaches include the use of Mass Spectrometry (MS) for process production and product release in both biologics and synthetic products. Additionally, they also comprise the enhancement of chromatographic techniques in specific Liquid Chromatography (LC), microcrystal electron diffraction, and methods for use as process analytical technology (PAT).

For biopharmaceuticals, MS was initially limited to the use of protein characterization to provide additional details for regulatory filings. Phase release/stability testing continues to be primarily based on traditional analytical methods like LC, Capillary Gel Electrophoresis (CGE), imaged Capillary Isoelectric Focusing (iCIEF), and Enzyme-Linked Immunosorbent Assays (ELISA) due to their simplicity and wide use in Quality Control (QC) laboratories. However, the incorporation of biosimilars, complex non-monoclonal antibody proteins (for example, fusion proteins), bispecific and hybrid drugs in the product pathway raises difficulties due to the failure to obtain a detailed understanding of these molecules through platform approaches.

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In addition to using peptide mapping concepts in Multi-Attribute Methods (MAMs), large biopharmaceutical firms are also using MS-based identity methods to unlock biologic medicines and drug materials. MAM is a peptide mapping assay based on LC/MS. Unlike profile-based traditional analytical assays, which rely on whole or partial proteins, MAM can classify and measure protein modifications at the amino acids level. It can provide more detailed information on attributes relevant to product consistency.

MAM is perhaps the most critical new analytical technique used in the production and release, and stability testing of therapeutic proteins. In small-molecule drug production and commercialization, MS detection systems are no longer called simply analysis instruments. They are primarily used for routine QC monitoring, such as determining extremely low-level impurities such as genotoxic impurities/potential genotoxic impurities.

These developments are most likely a response to new regulatory recommendations provided by agencies, but often due to particular problems that have emerged in the market, such as recent questions about N-nitrosamine residual discoveries in sartans.