Chromatography in Biologics Manufacturing: Purification Science, Resin Applications, and System Qualification
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...
Read MoreFrom Day One Success to Everyday Improvement: The OR → OE Continuum
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...
Read MoreWINDSOR FRAMEWORK: WHAT IS IT?
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...
Read MoreBalancing Scalability, Speed, and Quality in Pharma Startups
Pharmaceutical companies today face a high-stakes equation: launch faster, meet global demand, and maintain quality and compliance—without fail. That means simultaneously spinning up manufacturing sites,...
Read MoreNavigating Regulatory Complexity in Life Sciences: Turning Compliance into a Strategic Advantage
As global regulations continue to evolve, life sciences companies are facing increasing pressure to meet stringent compliance requirements without slowing down innovation or compromising product...
Read MoreEngaging Early: FDA’s Collaborative Pathways for AI in Regulatory Applications (Part 3 of 3)
Nick Armstrong, Senior Director of Digital Enablement at CAI and co-chair of the ISPE Community of Practice on AI, specializes in the intersection of artificial...
Read MoreA Framework for Trust: Understanding the FDA’s AI Risk-Based Credibility Assessment (Part 1 of 3)
Nick Armstrong, Senior Director of Digital Enablement at CAI and co-chair of the ISPE Community of Practice on AI, specializes in the intersection of artificial...
Read MoreInnovative Approaches to Quality and Engineering Management: Transforming Life Sciences Manufacturing
The path to operational excellence is continually being redefined. Today’s manufacturers face mounting pressure to enhance product quality, improve compliance, and optimize operational efficiency—all while...
Read MoreThe Future of AI-Driven Operational Readiness – An Outcome-Based Approach to Enhanced Process Validation and Asset Performance
As AI and related technologies continue to advance, the potential to reshape operational readiness grows exponentially. The future of AI for use in operational readiness...
Read More