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Specification Equivalence—A Practical Approach

December 30th 2024

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.

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Roche Introduces New Mass Spectrometry Analyzer

December 26th 2024

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Integrating Advanced Technologies for Pharma Analysis

December 8th 2024

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Comparability in Accelerated or Stressed Stability Studies Using a Quality Range

December 6th 2024

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Abzena Expands Analytical Services with GMP Cell-Based Potency Testing in US and UK

November 22nd 2024

Biologics Quality Control: The Growing Need for Accessible Proteomics

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

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