Development vs Commercial Outsourced Manufacturing Practices: Biologics

Report Overview

Each year, more CMOs expand their service offerings to include specialized development capabilities, particularly contract manufacturers focused on biologic drugs. Cell line development, process, analytical and formulation development, clinical trial manufacturing and commercial manufacturing for drug substance and drug product may be obtained from a single provider with end-to-end services. Knowing whether this is the best approach for your organization is challenging. This report dives into how the decision-making process differs among drug innovators outsourcing development activities from those outsourcing commercial manufacturing when it comes to CMO/CDMO selection criteria, use patterns, preferences and perceived leadership. Readers will gain insight into four different outsourcing scenarios for biologic drugs enabling them to make more educated purchases of CMO services based on their unique needs. CMOs will gain a better understanding of customers’ requirements and how they change as a compound moves through the development to commercialization process.

How you can use this report:

Drug Developers

• Differences in CMO engagement and usage patterns based on outsourcing stage and internal capabilities and/or capacity
• Key differences in CMO selection drivers based on four different outsourcing scenarios: development-stage API manufacturing, commercial API manufacturing, development-stage drug product manufacturing and commercial drug product manufacturing
• Learn which CMO attributes are becoming more important to different types of outsourcing peers in order to gain advantages from their experiences

Contract Manufacturers

• Ways to improve your company’s sales and marketing strategies to specifically address the needs of different customer bases, as identified in CMO selection criteria, during specific decision-making scenarios
• Outsourcing propensity of the different buyers of outsourced services for both drug substance and drug product manufacturing
• How CMO awareness, familiarity, leadership, proposal volume, use and preference vary between outsourcers of development-stage or commercial-scale manufacturing in order to target specific audiences with the precise information they need

Major Topics:

• Outsourcing Philosophies and Practices
• CMO Perceptions and Interactions
• CMO Selection Drivers
• Study Data