February 10, 2023
How to choose a CDMO? 7 Considerations to be made
Choosing the right CDMO (contract development and manufacturing organization) or CMO (contract manufacturing organization) to work with is an important decision. Irrespective of which stage - initial formulation during drug development or commercial production - biopharma and pharma companies find themselves in, there are certain things to consider that are valid for any stage throughout your production process.
Pharmaceutical companies are most likely looking for establishing long-term partnerships for their outsourcing rather than having to change their CDMO partners regularly. Topics to take into consideration for the selection are the level of product development and process development, but also questions regarding supply chain as well as validation and quality.
1: Status quo
Prior to making any decisions with regards to the ideal contract manufacturing partner, biotech and pharma companies should evaluate their status quo. Drug development will most likely come associated with different demands than for instance new drugs that have already got the necessary approval by FDA, EMA and other agencies. Potential CDMO partners are typically well-versed in any product-specific regulatory requirements and have a successful track record of compliance.
2: Identification of needs
Next comes the establishment of internal outsourcing drivers - after noting the status quo, the exact need for support or the type of support for API (active pharmaceutical ingredients) manufacturing can be identified. It certainly pays off to dedicate time and effort to identify outsourcing drivers and select a model that matches company needs and resources. By following some simple considerations, drug developers can build strategic outsourcing relationships where their in-house expertise is complemented by resources of an external service provider.
Identification of those issues will help drug developers prioritize needs, which is important when it comes to choosing the best fit for their CDMO partnership.
3: CDMO with right capabilities & expertise
The next step is to consider both the capabilities and expertise that the right CDMO should bring to the table in order to ideally complement in-house resources while adhering to predetermined quality standards. System compatibility and scalability are important aspects to consider.
Furthermore, capacities, capabilities and expertise need to be among the key considerations, as they will differ depending on the individual requirements - in other words, a drug product that is still being developed has other needs in terms of capacities than a new drug that is one step away from commercialization.
4: Speed of the CDMO
How fast can CDMOs produce for biopharma and biotech companies? Apart from the obvious - production speed and observance of timelines - they should ask the question of how fast and reliable the CMO is in communication and coordination matters.
Usually, potential CDMOs are selected depending on whether they can offer fast, efficient and flexible solutions.
5: How to determine reliability & confidentiality?
Reliability and confidentiality are other important factors and a must in a successful partnership. How much a contracting partner values client confidentiality should be of personal interest to any pharmaceutical company. This includes seemingly meaningless considerations such as whether they share names of other partners or which safety measurements they have in place regarding their documentation. But it also includes a seamless fulfillment of the scope of the contract.
In terms of reliability, one of the most pressing questions should be whether the CMO can and will comply with any standards associated with potentially necessary tech transfer and adhere to deadlines.
In fact, verifying reliability and confidentiality in advance is difficult. It is possible to rely on the experience of other companies, otherwise you have to trust on the quality of cooperation and the feeling during the contract initiation.
Sticking to realistic timelines, which in most cases are tight, is not enough, and costs - as well as cost transparency - play another major factor, be it during drug development for clinical trials or at a later stage. Most likely, costs are the decisive factor for choosing a CDMO.
Controlling costs and being able to stick to timelines relies on the knowledge of an experienced team, and pharma companies looking at outsourcing should make sure the right CDMO possesses knowledge of advanced technologies and state-of-the-art facilities.
7: Does the CDMO fit the company?
Lastly, the CDMO partner is advised to be the right fit for the respective organization in terms of culture, leadership and communications.
Collaborative and innovative aspects should also be considered. It is important to feel comfortable and trust the new partner when handing over in-house knowledge and to trust the new partner.
Outsourcing to CDMOs: Opportunity for growth
If done right, outsourcing to CDMOs certainly has great benefits, especially for young companies and start-ups that do not yet possess the means to cover all manufacturing stages in-house. Experience and expertise coupled with flexible available capacities and compliance with CMC standards or CGMP and GMP guidelines make API production easier for up-and-coming businesses. In the end, it’s always down to choosing the right partner, but also the right systems and platforms.
Single-use technologies are an ideal solution that help both CDMOs and self-sufficient companies improve their processes and push their output. Providers such as Single Use Support are striving to offer CDMOs end-to-end solutions that will improve quality, sustainability, scalability and efficiency in the long run.