One of the most important decisions you'll face in the early stages of your biopharma journey is whether or not to entrust a CDMO (contract development and manufacturing organization) with the development of your molecule. The quality, regulatory, cultural, and longer-term scale-up implications are heavy, and the checklist to ensure your outsourced partner operates as a true extension of your team is long. You'll need to vet their personnel, their finances, their facilities and equipment, their technology infrastructure, their quality and risk management strategies, their communication and transparency, their regulatory commitment and track record, and more.
While some of this is common sense, much of it is in fact tied to the ICH, EMA, and FDA regulatory obligations and guidance that's ultimately owned by you, the sponsor. In Outsourcing Fundamentals For Emerging Biopharmas, we've aggregated a collection of recent articles on the topic—all of them authored by veteran independent consultants and biopharma leaders—to offer you sound advice and insight. From ensuring a corporate culture match to writing a bullet-proof contract to meshing quality data systems, this BioProcess Online ebook is required reading for new and emerging biopharma companies considering a CDMO relationship.