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

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

Europe Updates Elemental Impurities Strategy

B&W Tek’s director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using handheld Raman spectrometers.

Analysis of Raw Materials

The European Pharmacopoeia Commission adopted a chapter on chemical imaging for analytical development, quality control, and manufacturing.

European Pharmacopoeia Publishes Chemical Imaging Chapter

Ashleigh Wake is director of Biological Services, Intertek.

Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.

Characterization and Impurity Analysis of Oligonucleotide Therapeutics

Niels VÃ¦ver Hartvig, PhD, is a principal specialist, at Novo Nordisk A/S, SmÃ¸rmosevej.

Liselotte Kamper is a chemist, at Novo Nordisk A/S,SmÃ¸rmosevej 17-19, DK-2880 BagsvÃ¦rd, Denmark.

The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.

A Statistical Decision System for Out-of-Trend Evaluation

Natalia Markova is principal scientist, MicroCal, Malvern Instruments.

Isothermal titration calorimetry and differential scanning calorimetry are valuable tools that can help accelerate drug development.

Using Microcalorimetry to Accelerate Drug Development

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

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.

Analytical Method Validation Using QbD and QRM

Cherie Schneider is associate research scientist-microbiologist at Pfizer CentreOne.

Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.

Overcoming Low Endotoxin Recovery

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

The Uniformity of Dosage Units test is used to evaluate content uniformity or weight variation or dosage forms such as tablets and capsules. The author introduces two different acceptance value limits (n = 10 and 30) in this article.

Establishing Acceptance Limits for Uniformity of Dosage Units: Part 1

Agilent’s new facility in Folsom, California includes laboratory, order fulfilment, and warehousing space.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes