Biopharmaceutical Analysis

The author describes techniques that can be used to provide the analytical data required by ICH Q6B for characterization of monoclonal antibodies.

Overcoming limitations of volumetric techniques and detecting transparent particles.

Achieving multiproduct development within shortened timelines.

Making chemically defined media work.

Use it label-free, or add labels to detect contaminants in solution.

By providing information on the relative accessibility of locations within a protein, HDX by mass spectrometry opens new windows into the higher order structure of biomolecules.

Spectroscopic methods such as circular dichroism can detect subtle differences in higher order structure before and after changes in process and formulation.

Simple methods can characterize polysaccharide vaccines and recombinant cytokines at high resolution.

A systematic approach facilitates formulation component selection.

Salt-tolerant adsorption and unique selectivity are the major advantages of mixed-mode materials over single-mode resins.

Membrane chromatography ensures purity at high flow rates.

The two-one-sided t-test compares the equivalency of two data sets.

STIC allows polishing to be carried out without an interstitial dilution step, which reduces process time and avoids additional buffer preparation and hold steps.

A stable alternative to Protein A chromatography.

A case study implementing rapid microbiological methods.

A better method for trend analysis than CUSUM and control charts.

Select the best approach to determine critical quality attributes.

By following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical development and testing

Without a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost.

This article reviews some of the commonly used approaches for process monitoring as well as the evolution of process monitoring in the Quality by Design (QbD) paradigm.

Can increase in ionic strength result in higher viscosity?

Robust packing procedures can improve process performance and increase resin lifetime.

Data on the performance and variability of different formats.