Analytics

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

In this interview, the main uses and benefits of NIR spectroscopy in tableting are discussed.


Putting NIR to Good Use in Tablet Formulation and Manufacture

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.


Regulating Excipient Quality, No Mean Feat

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

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

Balancing CMC Priorities

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


Tooling Up for Pharma

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


Analysis and Purification: Instrumental to BioPharma

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

Cambrex Announces Expansion of Scottish Solid-Form Screening Facility

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


Putting Endotoxins to the Test

Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.

Integrated First-in-Human Service Package for Poorly Soluble Small Molecules

Characterizing particles and understanding bulk powder behavior is critical to get the best pharma product.


Particles on Best Behavior

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Drug Substance Analysis