There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Anna Novikova, PhD, is a process analytical technology scientist at Fette Compacting, anovikova@fette-compacting.com.

Articles

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

The Road to Real-Time Release: At-line NIR Testing

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

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

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


Container Closure Integrity Testing of Finished Sterile Injectable Product

Wendy Saffell-Clemmer, BPS, is research director, R&D and innovation, at Baxter Healthcare.

Elizabeth Joseph is research scientist II, BioPharma Solutions at Baxter Healthcare Corporation.

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.

Stability Indicating Methods for Aluminum Adsorbed Vaccine Products

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

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

Plan Now to Share Your Expertise in 2020

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

New FT–IR Spectrometer Enhances Protagen Protein Services’ Analytical Capabilities

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

GNA Biosolutions Closes Latest Financing Round Backed by US/EU Consortium

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

Protein Analyzer Offers Ability to Measure Protein Titer Directly from Bioreactor

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

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

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes