Analytical Methods

Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.

A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an advancement over the traditional steady-state analysis of biomolecules.

As automation in biomanufacturing becomes more important, so does the need to integrate process data.

Leveraging vast quantities of analytical data requires digitalization and platform integration.

Determining a peptide’s purity is challenging because impurities are often structurally similar to each other and the API and can be present at very low concentrations. New approaches offer a solution.

When transferring a method from R&D to QC, success hinges on discovering where “the best” and “the most reliable” intersect.

Most extractable and leachable (E&L) studies are based on liquid formulations. This article examines options for E&L studies to evaluate leaching from primary packaging into lyophilized drugs.

SGS announces expansion of cell bank and bulk harvest testing services.

A new plasma B cell antibody discovery workflow launched by Berkeley Lights enables the shortening of antibody drug discovery from month to a day.

Kinetic models can be used to study aggregation and fragmentation to help ensure stability.

Microbial identity data can be critical for determining contamination sources.

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.

Application of multiple techniques at different conditions presents a more complete picture of a dynamic situation.

A project funded by BioProNET will investigate optimization for bioprocessing of gene therapy vectors using hydrodynamic fluid flow fields.

Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.

Experts discuss best practices for performing glycan analysis.

The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.

This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.

By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.

Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.

The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).