Analytics

Researching excipient grades and sources, as well as screening suppliers and materials, form the basis of programs to mitigate risk.

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.

The partners will collaborate on developing scale-up chip-based technology to enable commercial-scale production of a third-generation DNA synthesis platform.

The company’s new Milliflex Oasis System provides enhanced result reliability, increased productivity, and advanced traceability.

The Ireland-based company can now offer complete elemental impurities testing services.

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.

Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development.

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.

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.

As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.

This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.

The new service will assist pharmaceutical companies with quality control and analytical requirements.

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.

The company is expanding its bioanalytical capacity and capabilities to support biologic drug development, cell and gene therapy development, and biomarker analysis.

Pfizer has issued a voluntary recall of batches of its docetaxel injection 80 mg/8 mL due to impurity concerns.

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.

PPD is expanding its bioanalytical lab in Richmond, VA, to enhance its immunochemistry, biomarker, and chromatography services.

Cell DIVE is a new cell imaging technology from GE Healthcare that allows for more precise biomarker analysis.

The new microscope gives fast, deep, and clear images for live observation over long periods and allows scientists to study a larger range of applications.

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.

The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.

The editors welcome technical article contributions from the bio/pharma industry.