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

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Articles

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.

The Lifecycle Change of Process Validation and Analytical Testing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

Advances in PAT for Parenteral Drug Manufacturing

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

QbD paradigm advances process understanding in development and manufacturing.

Catching Up

New product reviews for March 2013, featuring automation, IT, and process control systems.

Product Spotlight: Automation/IT/Process Control

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

New handheld Raman technology is helping improve raw-material analysis and counterfeit-drug detection.

Handheld Point and Shoot Instrumentation Changes the Game for Raw-Materials Identification and Verification

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Equipment purchased today for the packaging line should be serialization-ready in preparation for upcoming requirements.

Be Prepared for Serialization

Two methods to evaluate retest data following out-of-specification results.

Calculating the Reportable Result from Retest Data

Mark Copley is Sales Director at Copley Scientific.

Even in an industry in which all product development is complicated by the intricacies of human biology, orally inhaled products (OIP) stand out as singularly demanding.

Improving Inhaled Product Testing: Methods for Obtaining Better In vitro-In vivo Relationships

Recent activity in standards-setting organizations has raised interest in the impact of testing for impurities that may enter the product before it is mined or harvested or even due to intentional use of some reagents.

Modernization of the Standards for Elemental Impurities

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Revisions to the United States Pharmacopeia (USP) General ChapterHeavy Metals have been much discussed over the past decade.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes