CDMO challenges that keep us up at night


Lukas Utiger
President, Drug Substance

4815 Emperor Blvd., Suite 300, Durham, NC 27703-8580, USA

Outsourcing, Overcoming Obstacles

Innovator and generic pharmaceutical companies turn to contract development and manufacturing organizations (CDMOs) for their process development (drug product, DP and drug substance, DS) and commercial manufacturing needs for prescription drugs. These requested services usually come with unique challenges, including difficult scale-up steps, as well as inaccurate or fast-changing product volume forecasts. In the past, delays in development and increases in short-term volume forecasts were managed by accessible and underutilized manufacturing capacity at CDMOs. However, such solutions are not feasible anymore, due to increased demand and complexity of development and production requirements.


Small and mid-sized pharmaceutical companies, which have limited manufacturing infrastructure, are driving this increased demand for capacity. These companies rely on CDMOs for a range of services, including regulatory filings, quality assurance, procurement and supply management support. Many of these companies are led by highly-skilled scientists with limited technology transfer, scale-up or manufacturing exp ...