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 US Pharmacopeial Conventional added to its international sites with the official opening of its facility in Sao Paulo, Brazil.

USP Opens Site in Brazil

Also, Tekmira will collaborate with Bristol-Myers Squibb, Helicos Biosciences appoints Steve Lombardi CEO, more...

Company and People Notes: CSL to Acquire Talecris, Benda Appoints George Zhou COO, More...

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

Actavis Voluntary Recalls Products for GMP Violations

The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

FDA Releases Draft Guidance on Residual Solvents

Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more...

Company and People Notes: Genentech Rejects Roche's Bid, TorreyPines CEO Retires, More...

Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more...

Company and People Notes: Meda will Acquire Valeant's Western and Eastern European Businesses, Catalent Names George L. Fotiades Interim President and CEO, More...

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.

FDA and Medicare at Odds?

Stephen H. Wu, PhD, is a technical fellow in the Pharmaceutical R&D division of Mallinckrodt PharmaceuticalâCovidien Ltd.

The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.

An Alternative to the USP Disintegration Test for Orally Disintegrating Tablets

The authors consider several common techniques for verifying the accuracy of liquid-handling equipment and offer guidance for finding the appropriate technique for a given instrument.

Comparing Calibration Technologies for Liquid-Handling Quality Assurance

Poonam Kushwaha is a lecturer of pharmacy at Integral University, Lucknow, India.

A. K. Madan is dean of Pharmaceutical Sciences at M. D. University

Extractables and leachables are a growing concern for pharmaceutical manufacturers and regulatory bodies.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes