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

Industry–academia collaborations seek to address unmet needs in measurement science.

Precompetitive Research Spurs Innovation in Pharmaceutical Analysis

The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.

Analytical Best Practices for Raw Materials Testing

Agnes Shanley is senior editor of Pharmaceutical Technology.

By reducing the number of assays needed and allowing product quality attributes to be measured end to end, MAM promises to allow users to gain product and process understanding much sooner than they could in the past, and to ensure quality and safety in a more efficient, streamlined way, throughout the product life cycle.

Multiple Attributes Monitoring: A New Phase in PAT for Biopharmaceuticals

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.

Complex Protein Studies Demand Dynamic Techniques

Jonathon Salsbury is an associate director at PPD GMP Lab, Middleton, WI.

Jeff Driscoll is an associate group leader at PPD GMP Lab, Middleton, WI.

Greg Maj is a scientist at PPD GMP Lab, Middleton, WI.

If a vortex mixer produces too much energy during sample preparation for particle size analysis, the size and morphology of particles can
change. A study compares the applied shear to sample suspensions of ibuprofen to observe the effects of applied shear on the particle size
distribution.

The Impact of Vortexing on the Particle-Size Distribution of Pharmaceuticals

Mario DiPaola is senior scientific director at Charles River Laboratories, Woburn, MA.

This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.

Best Practices in Analytical Method Development and Testing

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.

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.

Uniformity of Dosage Units, Part 1: Acceptance Value

Survey results and record attendance show positive signs for various bio/pharma regions.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes