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Chromatography in Biologics Manufacturing: Science, Purpose, and Resin Applications  Chromatography is a critical purification technique used in many evolving fields of biologics manufacturing including monoclonal...

Written by Paige Kane, PhD, CPIP   If you work in Life Sciences, you know that it is a complex, high-stakes operation.  I’ve been through my...

Elevating human performance in pharma starts with addressing the workforce shortage and continues by transforming how organizations develop and support their people. Through strategic collaboration...

Speed to patient is a primary driver behind the industry's shift toward modern commissioning and qualification (C&Q) practices, while still ensuring product quality and patient...

The 2023 revision of EU GMP Annex 1 reset the global standard for sterile manufacturing. It expands the guidance, tightens contamination-control expectations and aligns requirements...

The Windsor Framework (WF), which came into effect on January 1, 2025, is a significant agreement between the UK and the EU that replaces the...

August 11, 2025 – Indianapolis, IN — CAI, a global leader in operational readiness and excellence for high-stakes, regulated environments, is proud to announce the...

In 2008, the FDA issued guidance exempting most Phase 1 investigational drugs from the full scope of Title 21 of the Code of Federal Regulations...

CAI and Valkit.ai Form Strategic Partnership to Advance Gen2 AI-Augmented Validation (DVT) in Life Sciences  Indianapolis, IN – September 29, 2025 — CAI, a global...