04.17.25 -- Progress Report: Advancements In IDMP Readiness Efforts

The revised EU GMP Annex 1 mandates a comprehensive Contamination Control Strategy, continuous environmental monitoring, and species-level contaminant identification to ensure compliance.

Some drugs violate multiple Ro5 elements but remain developable, while some molecules adhere strictly to the Ro5, but their properties are not conducive to development.

What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.

Delve into why a biotechnology startup and CDMO views investment in a digitized validation lifecycle management system as crucial for accelerating innovation and reducing time to market.

Discover the latest trends and solutions in inhaled drug delivery, with a focus on overcoming dry powder formulation challenges to advance next-generation therapeutics.

Examine why organizations must integrate data and processes to enhance quality and insights to improve operational efficiency, patient health, and regulatory compliance.

Gain insight into the use of 3D cultured cancer models in the search for new therapies for complex diseases like cancer.

A drug manufacturer was facing challenges in buffer management. By implementing innovative inline buffer formulation technology, they were able to save space and increase efficiency.

Find out how a cost-effective high-content immunofluorescence workflow using the Revvity Opera Phenix™ system efficiently identifies small molecule protein degraders with multi-dimensional data.

Review the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

A pharma company faced a 4% yield drop and variability at a manufacturing facility. See how they leveraged an AI-based platform to unify data, pinpoint inefficiencies, and enhance consistency in yields.

CMOs and CPOs currently face significant challenges, including strong competition, high cost pressure, and more. Learn why being agile, flexible, and responsive is bound to pay off.