Abstract

The complexity of biopharmaceutical medicines meansthat each asset has unique features which need tobe considered fully to enable progression throughdevelopment: one size does not fi t all. Biotechnologycompanies are usually restrained by a lack of people,money and time which can cause challenges inoutsourcing biopharmaceutical manufacture. Successfuloutsourcing of manufacturing activities is howevercritical for biotech companies. With so much at stakeit is important that the biotech companies and theirinvestors rise to the challenges of outsourcing: budgetappropriately, have realistic timeframes, choose contractmanufacturing organisations CMOs wisely and if they donot have the resource or know-how, they engage expertswho do and early.