BioPharm International-10-01-2006

BioPharm International

A Guide for Testing Biopharmaceuticals Part 2: Acceptance criteria and analytical method maintenance

October 01, 2006

Articles

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The first part of this article, published in the September 2006 issue, discussed general strategies for validation extensions to other test method components, laboratories and even different test methods.1This second part provides practical tips on how to maintain test method suitability long after the formal completion of analytical method validation (AMV) studies.

Outsourcing: Procurement Pros Shrink Supplier Base

October 01, 2006

Columns and Departments

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A major shift is occurring in the way the biopharmaceutical industry sources goods and services. Price pressures at the retail end of the value chain and a difficult fundraising environment are forcing biopharmaceutical companies to take greater control of their costs. Purchased goods and services, including contract research and manufacturing services as well as raw materials and laboratory supplies, are a major expense in most companies, so control of those purchasing decisions is coming in for special scrutiny.