White Papers

Downstream process chromatography scientists are constantly seeking for better and more selective ways to remove aggregates and other process related impurities from a monoclonal antibody (mAb) monomer.

This buyer's guide discusses the available instrumentation for protein stability characterization, and what to consider when choosing stability assays. Protein stability and higher order structure is used to assist with biocomparability studies.

This white paper examines the issue of counterfeit drugs, reviewing the various types produced and the nature and range of the damage they cause. The report then focuses on analytical methods for tackling the problem, in particular the use of X-ray powder diffraction (XRPD).

This application note shows that the Epsilon 4 is fully capable of identifying small differences in materials. The finger printing technique is applicable to all materials including liquids, powders and solids.

The properties of polymeric excipients can directly affect the clinical efficacy, safety, and quality of a finished pharmaceutical product and are routinely identified as critical quality attributes (CQAs).

The Morphologi® ID can be used to compare material and chemical properties of Active Pharmaceutical Ingredients (APIs) in a drug product using Morphologically-Directed Raman Spectroscopy (MDRS®).

The quality of a material produced by a manufacturing process depends entirely on the process itself, and the robustness built into that process during the development lifecycle.

The Enabling Technologies Consortium™ (ETC) is a group of major pharmaceutical and biotechnology companies who collaborate on issues related to pharmaceutical chemistry, manufacturing, and control (CMC) for the benefit of the pharmaceutical industry.

Antibody-drug conjugates (ADCs) are promising anti- cancer biopharmaceuticals with one of the highest annual growth rates. Four ADCs received market approval to this point.

Particle size and size distribution are often important parameters in defining product performance.