Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

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

Emerging Therapies Drive Analytical Advancements

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

Analyzing Exabytes

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

SmithKline Beecham Gets Warned for Contamination

July 19, 2016

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

EAG Inc. Rebrands Businesses, Including ABC Labs, as EAG Laboratories

July 12, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

EAG Laboratories announces new company identity and intent to expand testing, analysis, and characterization capabilities across multiple markets.

FDA Releases Draft Elemental Impurities Guidance

July 06, 2016

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

Planning a Biologics Facility Start Up

July 02, 2016

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

Evaluating Practical Uses of Molecular Isotopic Engineering

July 02, 2016

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.

PTSM: Pharmaceutical Technology Sourcing and Management