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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, […]

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 […]

CPHI (Convention on Pharmaceutical Ingredients) is the leading global gathering for the pharmaceutical industry. It brings together research, development and manufacturing experts to forge partnerships that drive new therapies and innovations for patients everywhere. Covering the full supply chain, from […]

How to Assess Pre-Filled Syringe CDMO Readiness Contents What Makes a CDMO Ready for Pre-Filled Syringe Technology Transfer? Aseptic Fill-Finish Infrastructure Container Format Compatibility and Platform Syringe Systems Automated Inspection and Zero-Defect Quality Standards Regulatory Certification and Multi-Market Readiness Commercial […]

For commercial pre-filled syringe manufacturing in Europe, a CDMO should combine five essential capabilities: proven sterile fill-finish expertise, prefilled syringe and device know-how, validated commercial-scale capacity, mature European GMP quality systems, and robust release testing and supply continuity. These capabilities […]

Sterile fill-finish capacity is one of the most critical outsourcing decisions in injectable drug development. For pharmaceutical and biotech companies, the challenge is not only to find a contract manufacturer able to fill a Phase I clinical batch. The real […]