Articles by Steven S. Kuwahara - BioPharm International



Articles by Steven S. Kuwahara

Steven S. Kuwahara

A 25-Year Retrospective on Bio-Engineering
July 1, 2012

Steven S. Kuwahara, PhD, principal consultant at GXP BioTechnology LLC, gives an update on "Engineering the Cell-System Interface."

A History of the OOS Problem
November 1, 2007

Contrary to popular belief, the out-of-specification problem started years before the Barr Decision.

Final Word: Political Will is the Backbone of Regulation Enforcement
May 1, 2007

Lax enforcement arising from a lack of political will creates the potential for a loss of public confidence.

Book Review: Advances in Biopharmaceutical Technology in China
April 1, 2007

This 1,230-page tome is a must-have encyclopedia for any person or organization planning to interact with the biopharmaceutical market in China. It contains 23 well-written chapters and five appendices written by individuals who are experts in the areas they address. Some of these experts are not well known in the US; thus the book also provides an excellent introduction to people whose knowledge and opinions are important when considering biopharmaceuticals in China. Many chapters were translated from Chinese and this is the first time that their information has been provided to the West.

Disposables in the Quality Control Laboratory
November 2, 2006

The deliberate reuse of disposables has caused many clinically significant problems.

Final Word: Outsourcing to Developing Countries
November 1, 2006

In the rush to save money, the consequences of potential problems often are ignored.

Validation of Microbiological Tests
March 1, 2005

The variety of microbiological tests makes it difficult, if not impossible, to prescribe a single, comprehensive method for validating all types of tests. By their very nature, microbiological tests possess properties that make them different from chemical tests. Consequently, the well-known procedures for validating chemical tests are not appropriate for many microbiological tests. Yet, it is necessary to validate microbiological tests if they are to be useful for controlling the quality of drug products and devices. Test-method validation provides assurance that a method is suitable for its intended use. Given this definition, any rational company would want to be sure that its methods are validated.



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