The Column-12-12-2017

The discovery and development of biopharmaceuticals that target specific diseases can be transformative for people living with illness. However, bringing a new therapy to market is a prolonged and costly process mired in uncertainty. Ensuring safety, efficacy, and product quality is paramount. Biopharmaceuticals, by their nature, are highly complex. A myriad of heterogeneity can be intentionally functional, an unwanted consequence of manufacturing and storage, or generated by biological modification in vivo. Not all, but some post-translational modifications or biotransformations can impact development, manufacturing, safety, efficacy, and overall product quality. These critical quality attributes (CQAs) need to be identified, characterized, controlled, and monitored throughout the drug discovery and development cycle. Specialty measurement using mass spectrometry (MS) continues to play an ever‑increasing role across the continuum.

Colloidal interactions arising from surface-exposed moieties on therapeutic proteins, monoclonal antibodies, antibody–drug conjugates, and other biopharmaceuticals lie at the heart of drug product stability. Therefore, it is not surprising that much effort has been devoted to finding effective means to characterize these interactions and to rapidly screen drug candidates and formulations for optimal colloidal properties. The most common techniques for performing these analyses are based on analytical light scattering, in its two primary flavours: static light scattering (SLS) and dynamic light scattering (DLS). Recent advances in light scattering instrumentation, analytical methods, and algorithms provide developers of biologics with powerful tools to perform these studies.

Tips for effective use of chromatography and mass spectrometry (MS) for the analysis of antibody–drug conjugates, glycoengineered proteins, and biosimilars.

Biotherapeutics must endure in-depth testing to validate their efficacy and safety before their release to the medical community. Characterization and quantitation of these large molecule medicines is traditionally performed with ligand binding assays or radiolabeling procedures. Issues with selectivity, accuracy, and unavailability of applicable assays for the characterization and quantitation of certain biotherapeutics means that liquid chromatography–mass spectrometry (LC–MS) is becoming an increasingly selected method for biotherapeutics testing. Typically used for small molecules, LC–MS can be adapted for larger molecule analysis with additional high throughput and multiplexing capabilities. New method development has turned LC–MS into a highly sensitive option for biotherapeutics validation.

The LCGC Europe/HTC-15 Innovation Award was launched to celebrate the work of scientists who are innovatively evolving the field of hyphenated techniques.

The newly appointed Chromatographic Society Lecturer, Mel Euerby, visited the University of Sunderland in early November in the first official outing of the role.

Researchers from University College London have developed a novel method of characterizing the mechanical strength of agarose-based chromatography resins used in the manufacturing of biopharmaceuticals.

Avantor Inc. has completed the acquisition of VWR Corporation for an approximate amount of $6.5 billion.

Click the title above to open The Column December 12, 2017 Europe & Asia issue, Volume 13, Number 18, in an interactive PDF format.

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