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

Articles

Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.

FDA Cites Three Ipca Facilities for Multiple Violations

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.

The Use of 2D-NMR for the Assessment of Biosimilarity

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

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

Going Small to Achieve Commercial-Scale Success

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Performing a measurement uncertainty calculation is often seen as problematic.

Measurement Uncertainty without the Math

Agnes Shanley is senior editor of Pharmaceutical Technology.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Exploring New Connections in the Lab of Tomorrow

Keith Moore, vice-president of analytical services, Metrics Contract Services discusses gains use in dissolution testing.

UV Spectroscopy Gains Use in Dissolution Testing

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

Emerging Analytical Technologies Advance Biopharma Development

Advances for Bio/Pharma Analytical Laboratories

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

European Pharmacopoeia Publishes Chemometrics Chapter

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes