The Challenges of moving a Bioconjugate Candidate from Clinic to Market

The path to market of a novel drug is complex and uncertain. Under the growing pressure of regulation and competition, drug developers need to successfully navigate through the journey while carefully managing technical and financial risk. Besides the challenges of gaining regulatory approval, production at commercial scale, or planning carefully for capacity to meet market demand, going to market with a bioconjugates or ADC candidate implies additional complexity. These biotherapeutics are built of multiple different components, therefore their manufacturing and highly complex supply chain request specific know-how and capabilities to succeed in commercial settings.