Selection of API CDMO - Part 1/3
Nelson M. Lugo, Owner and Principle Consultant of Nelson M Lugo Consultants
5 August 2019
Contract manufacturing provides a clear competitive advantage to many biopharmaceutical and traditional pharmaceutical organizations that do not have the time, capacity and resources to operate internal manufacturing activities. A vast majority of these firms do not have internal manufacturing capacity to produce the multitude of products expected in the market in the next decade. To this end biopharmaceutical firms must rely on and work closely with Contract Manufacturing Organizations (CMOs). A contract manufacturing organization (CMO), sometimes called a contract development and manufacturing organization (CDMO), is a company that serves other companies in the pharmaceutical or biopharmaceutical industry on a contract basis to provide comprehensive services from drug development through drug manufacturing including toxicological, clinical trial and commercial production. The primary objective of this article is to introduce the reader to the process of identifying, selecting, negotiating, implementing and managing API (Active Pharmaceutical Ingredient) CMOs or CDMOs. This is Part 1 of a Series of 3 segments outlining the pivotal phases in securing the right CDMO API partner with due diligence for long term success.
The API CDMO selection process incorporates multiple stages which set the frame work for continued relationship management. The steps and stages that will be covered in each segment include; marked up in bold below.
(Table of content)
- The Teams
- Stage 1 - Planning and Organization
- Stage 2 - Select
- Stage 3 - Negotiate
- Stage 4 - Implement
- Stage 5 - Manage
- Expected Deliverables
Keywords for the article: CMO (Contract Manufacturing Organization, CDMO (Contract Development and Manufacturing Organization), API (Active Pharmaceutical Ingredient)