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Sterile Manufacturing Trends: What Pharma Companies Need from CDMOs in an Annex 1 Environment

Adapted from an article originally published in ONDrug Delivery. Sterile drug manufacturing is evolving rapidly. New therapeutic modalities, more patient-centric delivery formats and stricter regulatory expectations are reshaping how sterile products are developed, filled, monitored and scaled. For pharmaceutical companies, […]

How to Assess a Small Molecule HPAPI CDMO in 2026

Contents What Defines a High-Potency Active Pharmaceutical Ingredient Programme? Occupational Exposure Classification and Containment Strategy Small Molecule Formulation Expertise Analytical Development and Method Validation Technology Transfer and Scale-Up Readiness Regulatory and Good Manufacturing Practice Compliance Integration Across the Development-to-Supply Pathway […]

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