Analytical Method Development

Metrology has the potential to not only prevent harm to patients but also to support innovative therapeutic options.

The authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.

Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.

Bio-chromatography development and manufacturing company, BIA Separations, has signed a license agreement with the University of Zagreb to commercialize a novel elution method for virus and viral vector purification.

Synthetic biology can help researchers circumvent the challenges of traditional methods of antibody generation.

Analytical solutions are improving for raw material testing, drug product release process development, and more.

Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.

Past mistakes and misstatements have adversely influenced industry decontamination practices with vapor phase hydrogen peroxide, and this article endeavors to clarify the process.

The aim of this study was to prepare taste-masked drug-resin complex using ion exchange resin Kyron T-134.

GE Healthcare Life Sciences and Advanced Solutions Life Sciences (ASLS) are partnering on 3D-printing of tissues that can be used for discovery and cytotoxicity testing.

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.

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.

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.

At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.

As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.

GNA Biosolutions has completed its latest round of Series C financing in which it raised US$13.5 million.

The Tridex Protein Analyzer from IDEX offers the ability to directly measure protein titer from a bioreactor in real time.

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.

The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.

Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

Using advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.

Key considerations when searching for an analytical service provider include workflow, hardware, and regulatory support.

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.

Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Empty and prefilled syringes must pass a range of quality control tests.