Pharmaceutical Technology-04-02-2009

Pharmaceutical Technology

Silicone Microdroplets in Protein Formulations—Detection and Enumeration

April 02, 2009

Peer-Reviewed Research

33

4

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.

Reference-Standard Material Qualification

April 02, 2009

Peer-Reviewed Research

33

4

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.

Insider Solutions: Device Database Can Help Pharma

April 02, 2009

Insider Solutions

33

4

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

Downpayment on Health Reform

April 02, 2009

Online Exclusive

33

4

President Obama's economic recovery plain includes goals such as reducing the number of uninsured citizens and improving the quality of healthcare.

Out of Control

April 02, 2009

Agent-In-Place

33

4

GMP agents report on old products, aseptic violations, and unexpected emotions.