Analytics

Articles

The authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.

Methods for the Automated Manufacturing of an Autologous Dendritic-Cell Immunotherapy

Angie Drakulich was editorial director of Pharmaceutical Technology.

A roundtable moderated by Angie Drakulich.

Real Time Release Testing: Analytical Methods and Innovations

The author examines the process of method development, with reference to ISO 13320:2009 and relevant monographs from the United States and European pharmacopoeias.

Method Development for Laser-Diffraction Particle-Size Analysis

The author reviews test methods for microbiological cleaning processes and suggests ways to improve microbial bioburden method suitability studies.

Bioburden Method Suitability for Cleaning and Sanitation Monitoring: How Far Do We Have to Go?

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

A method for determining sample size is finally getting some respect.

Statistical Solutions: Bergum's Method Recognized

Janie Dubois is Product Manager, Analytical Imaging, Malvern Instruments (USA).

The author assesses the power and limitations of NIR chemical imaging and its future.

When and why should the pharmaceutical industry use NIR chemical imaging?

Alice Laures is an analytical chemist in analytical sciences/chemical development at GlaxoSmithKline in the UK.

George Okafo is a manager in Scinovo, Preclinical Development at GlaxoSmithKline (UK).

Patrick Johnson is an analytical chemist in analytical sciences/chemical development at GlaxoSmithKline in the UK.

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.

Reduced-Method Robustness Testing of Analytical Methods Driven by a Risk-Based Approach

Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain - traditionally produced vaccines take approximately 6 months.

Can new vaccine manufacture method cut time to market by half?

Pharmaceutical Technology talked to drugmakers, equipment vendors, and service providers to learn more about the advantages and disadvantages of rapid microbial-detection methods.

An Overview of Rapid Microbial-Detection Methods

Dr Martin Cockcroft, Operations Manager at Tepnel Pharmaceutical Services, an established business of Gen-Probe Inc., speaks about harmonized microbiology methods.

Analytical Method Development