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

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Articles

New software platforms aim to help manufacturers implement connected technology and use data efficiently.

Using the Internet of Things to Manage Manufacturing Equipment

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilization

Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.

EAG Laboratories Opens Dedicated ICP-MS Lab

Idifarma has announced a growth of more than 50% over the past two years. Revenue is expected to hit approximately EUR5.3 million in 2016, growing from EUR3.5 million in 2014.

Idifarma Reports Record Growth

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

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

Application of QbD and QRM to Analytical Method Validation

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.

Dissolution Testing

World’s first systemFully automated sample preparation module for LC-MS

Nexera-i MTUHPLC and HPLC analysis on a single system

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

ICH Introduces Two New Guidelines

Recipharm announced that it has invested 5 million SEK in a new GLP bioanalysis laboratory in Uppsala.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes