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There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.
Effective analytics will eliminate failures, deviations, and non-conformances.
November 20, 2019
The new service will assist pharmaceutical companies with quality control and analytical requirements.
November 02, 2019
The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.
October 31, 2019
The company is expanding its bioanalytical capacity and capabilities to support biologic drug development, cell and gene therapy development, and biomarker analysis.
October 24, 2019
Pfizer has issued a voluntary recall of batches of its docetaxel injection 80 mg/8 mL due to impurity concerns.
October 02, 2019
The root cause of NDMA contamination may go well beyond manufacturing problems, to the molecule itself.
In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.
Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution.
The author provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in the API or drug product, and avoiding negative product regulation late in the development and/or marketing process, including expensive recalls.
Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
September 27, 2019
PPD is expanding its bioanalytical lab in Richmond, VA, to enhance its immunochemistry, biomarker, and chromatography services.