Insights into CDMO Selection from the External Manufacturing Department

Report Overview

ISR conducted 14 in-depth interviews with professionals who work in the External Manufacturing department at biopharmaceutical companies of various sizes (based on employee numbers and revenue) in the US and Europe. The objective of the interviews was to understand their role at their company and the part they play as an intermediary between their organization and their network of manufacturing suppliers.

This report takes an in-depth look at how members of the External Manufacturing team identify and evaluate new CDMOs, tips on how to develop strong relationships with outsourced manufacturers, how various CDMO traits and capabilities influence their selection decision, and general preferences these interviewees have developed over their careers. Additionally, ISR asked about the main challenges External Manufacturing professionals are currently facing as well as potential solutions to these challenges.

What you will learn:

Drug Developers:

• How experienced outsourcers identify new CDMOs
• Potential solutions to outsourcing and supply chain challenges
• Key components to establishing successful relationships with contract manufacturers

Contract Manufacturers:

• Which CDMO traits matter the most when choosing a new CDMO
• How cost, equipment, and geography factor into CDMO selection
• What outsourcers look for during their due diligence site visit

Major Topics:

• External Manufacturing’s Role in the CDMO Selection Process
  • Identifying New Manufacturing Partners
  • Reasons why a sponsor might look for a new CDMO instead of allocating more work to an approved vendor
  • Resources used to identify new CDMOs
  • When in a product’s lifecycle the search for a CDMO typically begins
• The CDMO Evaluation Process
  • RFPs /RFIs
  • Frequency of site visits and what the External Manufacturing team looks for in an audit
  • Evaluation timelines and satisfaction level
• Factors that Influence CDMO Selection
  • Top CDMO selection characteristics
  • How a CDMO’s technology/equipment, location, and cost factor into the selection decision
  • Selection differences by product stage and/or type
  • Frequency of switching CDMOs
• Vendor Preferences
  • Full Service vs Specialty CDMOs
  • Analytical Testing Capabilities
  • Use of Strategic / Preferred Vendors
• Main Outsourcing Challenges and Potential Solutions