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 International Society for Pharmaceutical Engineering will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide and contain practical information about technological advances in sterile manufacturing.

ISPE to Publish Updated Sterile-Product Manufacturing Guide

Powder Systems Ltd's (PSL's) new GFD&#153; isolator combines the latest innovation to provide a high containment lab scale filtration and drying solution with the same reliability and benefits as PSL high containment production size filter dryers.

New lab glass filter dryer isolator technology

The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be controlled during the compression process by adjusting certain machine parameters.

A Design of Experiments for Tablet Compression

Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.

FDA Perspectives: Understanding Challenges to Quality by Design

Might European officials reverse their position on acceptable production methods?

Regulators Debate Methods for Producing Water for Injection

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Industry buy-in is increasing as pharma companies proceed with select projects and research.

Continuous Progress in Continuous Manufacturing

New product reviews for September 2011 focusing on manufacturing.

In the Spotlight September 2011

The third in a series of eight case studies from the Product Quality Research Institute focuses on facility biocontainment and inactivation.

PQRI Case Study (3): Facility Biocontainment and Inactivation

Elham Blouet is Pharmaceutical Project & Development Manager, Pharmaceuticals & Cosmetics BU, at Roquette.

Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.

Carbohydrates For Injection

Dr Jerry Sellors is IR business manager, analytical sciences and laboratory services, at PerkinElmer.

Paul Smith is EMEAI laboratory compliance productivity specialist at Agilent Technologies UK Ltd, 610 Wharefedale Road, IQ Winnersh, Wokingham, Berkshire RG41 5TP, United Kingdom, paul_smith@agilent.com

By providing an information "fingerprint", infrared red spectroscopy is a useful tool for identifying counterfeit pharmaceuticals. The authors identify best practices for ensuring compliance.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes