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

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Articles

The incoming administration has renewed hope for stem cells, but less adequate copycats may follow.

A New Start for New Cells

Brief pharmaceutical news items for January 2009.

Pharma Capsules

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

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

The USP public-comment process exists for a reason. Industry needs to take advantage. This article contains bonus online-exclusive material.

Insider Solutions: Have a Say in USP Standards

Instead of hampering progress, cost pressures might inspire Big Pharma to get creative.

Will 2009 Bring Innovation?

Also, Crucell and DSM announce deals with GSK, Talecris, and CSL; Nobel Prize winner Luc Montagnier joins Viral Genetics; more...

Company and People Notes: Abbott to Acquire Ibis Biosciences; Pfizer Appoints Senior VP of Litigation; More...

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The US Food and Drug Administration issued a draft guidance, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.

FDA Issues Draft Guidance of Genotoxic Impurities

Also, BASF opens lab in Mumbai; Evotek president and CEO to resign; more...

Company and People Notes: Hovione to Acquire Pfizer API site; Xceleron Appoints Michael Butler President and CEO; More...

At its annual business briefing held last week, Merck & Co. outlined its short- and long-term strategy for growth. Its strategy is focused on increased penetration in emerging markets, the establishment of a business for developing follow-on biologics or biosimilars, and a new commercial model for product life-cycle management.

Merck Forms Follow-On Biologics Business; Emphasizes Emerging Markets

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the December 2008 edition from Spiroflow Systems and Sepha.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes