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

The author discusses how to manage pending pharmacopeial changes.

Elemental Impurity Analysis

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.

A Statistical Review of ICH Q10 Pharmaceutical Quality System

Meticulous system configuration can prevent machines from taking over.

Technology Fights Back

The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.

GMPs for Method Validation in Early Development: An Industry Perspective (Part II)

Robert Clifford is industrial business manager at Shimadzu Scientific Instruments. rhclifford@shimadzu.com

Minako Tanaka is a scientist at Shimadzu Applications Development Center, Kyoto, Japan, minako@shimadzu.com

Cleaning validation provides assurance that the quantity of residual substances collected from equipment surfaces are within permissible limits, helping to ensure quality control and safety in pharmaceutical manufacturing facilities. Three different cleaning validation methods for measuring the carbon in residual samples of various pharmaceutical substances were compared.

Carbon Measurement Methods for Cleaning Validation: Comparing Direct Combustion with Rinse and Swab Sampling Methods.

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Experts share insights into analytical tools and techniques.

Analytical Tools for a Quality-by-Design Approach to Lyophilization

We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?

Product Neutralization for Rapid Microbiological Test Methods

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Industry experts share their insight on solid-dosage and sterile manufacturing.

35th Anniversary Special: Breakthroughs and Emerging Technologies in Manufacturing

IQ Consortium representatives explore industry approaches for applying GMPs in early development.

Careful attention to detail will help to prevent valuable assets from "melting" away.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes