For many pharmaceutical companies that do not have their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical consideration in the management of parenteral products. This webinar reviews the importance of finding a partner with extensive experience in the parenteral arena as products move through clinical phases and toward commercialization.
Small contract development and manufacturing organizations (CDMOs) can often provide early-phase material but may not be able to meet the rigorous demands of late stages and commercialization. This article examines key criteria for selecting the right CDMO partner and includes a case study that shares the challenges involved in a late-phase technology transfer for a parenteral product.
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make those decisions.
It is clear that demand forecasting is a significant challenge when planning biologic drug substance production. Overestimating demand can lead to higher per unit cost and disposal expenses, while underestimating it can result in missed market opportunities and negative reputational consequences for the company.
The challenges, risks, and costs of bringing complex large molecule products to market are growing exponentially. Gaining a competitive advantage is more difficult. Drawing on 20 years of biologic experience, Thermo Fisher Scientific offers you flexible end-to-end solutions and expertise in development and manufacturing