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 authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.

Silicone Microdroplets in Protein Formulations—Detection and Enumeration

Also, SOCMA changes name; two FDA approvals; Biogen Idec names chief operating officer; more...

Company and People Notes: EMD Serono to Open Cambridge, MA, site; Akorn Appoints Interim CEO; More...

The author reviews the types of reference-standard materials used in drug-product manufacturing, discusses current regulatory requirements, and outlines a reference-standard qualification program.

Reference-Standard Material Qualification

Brief pharmaceutical news items for April 2009.

Pharma Capsules

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA is poised to gain authority and resources to ensure the quality of food and drugs.

Congress and Obama Seek to Bolster Drug Safety

By reducing cycle time and implementing quality-by-design inspired engineering, advanced lyophilization systems are driving the industry toward greater efficiency and control.

Deep Freeze: Innovations in Lyophilization

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Standards data is helpful, but FDA needs to apply its information across the board. This article contains bonus online-exclusive material.

Insider Solutions: Device Database Can Help Pharma

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Obama's cost-containment and science-innovation initiatives need to overlap.

Parallel Tracks

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The financial and economic downturn is likey to have long-term implications for outsourcing.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes