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

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

Articles

Statistical analysis shows how much testing is needed to deliver a reliable estimate result.

Is a Sample Size of n=6 a 'Magic' Number?

Susanne Keitel, MD, is head of the European Directorate for the Quality of Medicines of the Council of Europe. EDQM is responsible for the European Pharmacopoeia.

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

Finished Product Monographs in the European Pharmacopoeia

John Yin is applications specialist, Freeman Technology, Tewkesbury, UK

Experimental work on wet granulation demonstrates the use of dynamic powder characterization to support continuous processing for tablet manufacturing.

The Role of Powder Characterization in Continuous Manufacturing

Challenges encountered when implementing a continuous monitoring system are reviewed.

Achieving and Maintaining Compliance Using Continuous Monitoring Systems

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

Determining Protein Oxidation Induced During Fill-Finish Operations

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

Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.

Extractables and Leachables Testing

Mass Spectrometer Enhances Performance in Protein Analysis

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

Data integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes