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

Brief pharmaceutical news items for November 2008.

Pharma Capsules

Stefan Schuber, PhD, is director of scientific affairs at the United States Pharmacopeial Convention.

Anthony DeStefano, PhD, is 2013 president of the American Association of Pharmaceutical Scientists (AAPS).

Roger L. Williams, MD, is executive vice-president and chief executive officer, USP

William F. Koch, PhD, is chief metrology officer, USP

Darrell R. Abernethy, MD, PhD, is chief science officer, all at the United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8184, dra@usp.org

Attendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.

Inside USP: USP Metals Testing: A Workshop Report

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Pharma companies could benefit from the lessons learned in this fall's financial crisis.

Quality Counts

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Pharmaceutical Technology will feature video coverage of AAPS this month.

Bringing AAPS to You

Molecules called "chaperones" facilitate correct protein folding.

Coming Down the Pike: Chaperones

Diego Vargas is a senior engineer at Merck & Co.

Brian K. Meyer is a research fellow at Merck & Co., 770 Sumneytown Pike, West Point, PA 19486, tel. 215.652.3992, fax 215.652.5299.

The authors explain the factors that can cause a failure in a bubble-point integrity test and what to consider when a product-specific bubble point must be defined.

Establishing Material Compatibility, Process Conditions, and Bubble Points of Filters

Pascal Martin is a project manager at Merial SAS, Lyon, France, tel. +33 4 72 72 39 61, fax +33 4 72 72 34 93.

Magnus Stering is head of Application Services South Europe Filtration, Sartorius Stedim Biotech SA, Aubagne, France.

Jens Meyer is a product manager of integrity testing at Sartorius Stedim Biotech GmbH, Goettingen, Germany.

The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.

Improving the Integrity Test Assurance of Multiround Housings Assessments

Jonathan Royce is a senior application scientist at GE Healthcare.

Jeffrey Carter, PhD, is director of filtration R&D, at GE Healthcare, 14 Walkup Drive, Westborough, MA

Jakob Liderfelt is a scientist at GE Healthcare, Björkgatan 30, 751 84 Uppsala, Sweden.

Proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.

Guidelines for Selecting Normal Flow Filters

Yves Mayeresse is senior manager and head of freeze-drying at GlaxoSmithKline Biologicals.

The authors present an aseptic-filling process for freeze-dried liquids using the closed-vial technology.

Freeze-Drying with Closed Vials

Jerold Martin was the senior vice president of global scientific affairs at Pall Life Sciences and the chairman of the Board and Technology Committee at Bio-Process Systems Alliance.

The author examines re-use of hydrophilic- or hydrophobic-membrane sterilizing-grade filters in liquid sterilizing applications.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes