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White Papers

Results 41–50 of 123

Increase mAb purity with salt-tolerant cation exchanger

| Contributed by Tosoh

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

Protein stability analysis technologies for the biopharmaceutical industry

| Contributed by Malvern Panalytical

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.

Technology for combating counterfeit medicine

| Contributed by Malvern Panalytical

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).

Toothpaste identification by FingerPrint

| Contributed by Malvern Panalytical

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.

Exploring the Value of GPC/SEC in Polysaccharide Characterization

| Contributed by Malvern Panalytical

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).

In vitro bioequivalence studies for oral solid dose products

| Contributed by Malvern Panalytical

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®).

De‐Risking the Process of Peptide Manufacture

| Contributed by Bachem

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.

Debottlenecking R&D with Automated Powder Dispensing

| Contributed by Mettler Toledo

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 Conjugate Mimic Purification with TOYOPEARL® PPG-600M HIC RESIN for DAR-Separation

| Contributed by Tosoh

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.

Early stage product development using laser diffraction analysis

| Contributed by Malvern Panalytical

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

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