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Sterile Fill-Finish Capacity Planning from Phase I to Launch

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 […]

GMP Quality Systems for Semisolid and Liquid CDMOs: What Sponsors Should Expect Before Outsourcing Commercial Manufacturing

Outsourcing commercial manufacturing is never only a capacity decision. For creams, gels, ointments and non-sterile liquids, it is a quality, supply continuity and patient safety decision. A sponsor can transfer a formula, a method and a target batch size. What […]

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