White Papers

MDRS used to demonstrate pharmaceutical equivalence

Concentration measurement and sizing of bacteriophages and viruses

Antibody-drug conjugates (ADCs) are promising anticancer biopharmaceuticals with one of the highest annual growth rates.

Modern chromatography resins were evaluated for the purification of a bispecific antibody.

The strong cation exchange resin TOYOPEARL Sulfate-650F offers high salt-tolerance, wide working pH range, and high dynamic binding capacity.

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).