Companies that offer CDMO (Contract Developing and Manufacturing Organizations) services are companies that make their capacities available to third parties to develop projects and produce medicines for other pharmaceutical companies. CDMOs provide comprehensive services incorporating external third-party projects and offering their knowledge and development and manufacturing capabilities. Companies seeking and contracting CDMO services may do so for various reasons:
- Not having their own facilities to develop their project on a larger scale.
- Having their own capacity already saturated with other projects and willing to develop a greater number of projects.
- Not having generated enough technical knowledge internally and preferring to work with an expert company with more experience in the project.
- Strategically focused only on initial developments and commercialization of drugs.
- Wanting to limit or control the financial risk of the project not being approved by the health authority.
In the recent years of the pandemic with the development and manufacture of vaccines for the SARS-CoV-2 virus, the support provided by CDMO organizations has been essential to be able to respond to the required global needs. Undoubtedly, subcontracting activities of third parties by large biopharmaceutical companies (e.g. AstraZeneca) is an element that will influence the future of the development of biological products in the future. It has become clear that lack of capacity is a very limiting element in organizations that develop complex medicines such as biologics, especially injectables and steriles. The CDMOs have proven that they are up to the highest requirements of quality, supply and commitment demanded by the pharmaceutical and health industry.
On the other hand, the number of small or virtual biopharmaceutical companies is increasing significantly in the sector, since it implies a lower initial investment. Generally, these companies do not have their own capacity and need the services offered by CDMO organizations to develop their products in a fast and safely manner. Among other services, CDMOs can offer:
- Analytical methods development, transfer & qualification
- Technology Transfer Process
- Upstream & Downstream development
- Demo runs
- Comparability/ Similarity studies
- Stability studies
- Scaling up optimization
- Pre-PPQ and PPQ (Process Performance Qualification) campaigns
- Commercial manufacturing
- Regulatory support
Finally, the level of experience and knowledge that a CDMO organization has is very important when selecting one. The number of previous projects, the commitment offered, the dedicated team, the reliability and the comprehensive service offered by the different organizations are key aspects to take into account when choosing one or another CDMO organization.