Analytics

Regulatory bodies are taking a more stringent approach to excipient quality, but unlike guidance on GMP for APIs, those for excipients offer a framework only, meaning the onus lies with the manufacturer or supplier.

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.

Protagen Protein Services’ recently acquired Brucker Tensor II IR spectrometer significantly expands the company’s analytical capabilities.

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 design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.

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

Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.

Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.

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

Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.

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.

Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.

Tools help lab scientists capture and use more data and work to ensure data integrity.

Bio/pharmaceutical companies are adopting artificial intelligence for discovery, development, risk assessment, safety monitoring, and manufacturing.

Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland.

This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices.

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

The Gyrolab E. coli HCP Kit quantifies host cell protein impurities from Escherichia coli expression systems used in biotherapeutic production.

Cytek Biosciences’ Cytek Aurora advanced flow cytometry system uses five lasers to enable seeing more than 30 colors from a single sample.

SCIEX added new innovations to improve laboratory workflows and data acquisition from samples.

The new flow cytometer system boasts enhanced sensitivity and user-friendly features.

The new platform from Berkeley Lights allows scientists to more easily analyze large numbers of cells in a short period of time.