For many drug developing companies, the selection of the right CDMO that will fulfill the activities from Cell Line Development to the manufacturing of the clinical batches is a challenging stage. This becomes even more unclear and doubtful for startups, that have low to no experience in CMC activities, and not the necessary funds to hire the right people to lead them.
Not Only for Pharma Companies
The subcontractor’s selection’s process is a tricky task and not only for pharma companies. Any company that needs to manufacture or develop a product (or both) has to go through the similar process. Let’s have a look at it:
- Define the selection criteria,
- Screen the potential subcontractors,
- Write and send them an RFI,
- Assess the information received,
- Write and send them an RFP,
- Assess the proposals received,
- Audit a short list of subcontractors,
- Choose the one that fits best your needs.
Charts have been proposed to guide the companies through this tough choice. They can be helpful to define what are the criteria that you should assess, but in the end, the most important criteria are your product specific ones. There is not one list or matrix that fits all subcontractors’ selection, more specifically in drug development where all candidates are different!
3Biotech has a solid experience in choosing subcontractors during drug development. The most time consuming one is probably the choice of the CDMO that will develop the processes (USP and DSP) and then manufacture the clinical batches. According to our experience, the most efficient process is the one below:
A technical visit can be added to this process, and we recommend it. It should take place after receiving the proposals and before performing the quality audit. The purpose of this technical visit is first to globally assess the capabilities of the subcontractor, but also to assess the teams of the CDMO and meat a key person: the future Project Manager.
Some would add an RFQ, between the technical visit and the audit. The purpose of an RFQ is to have a deeper understanding of the fees shown in the RFP. Useful for large companies, this can become a true labyrinthine system for startups, wasting them a lot of time and lowering the importance of the selection criteria defined in step one of our process.
It is recommended that the selection criteria are shown in a table and rank them. A template of an efficient table is Dickson’s one (see above). We find it accurate and sufficient. It is easy to imagine too many criteria and end-up with a labyrinthine system that eventually no one will use, so keep it simple and efficient.
This whole process might look easy at first glance, but a lot of questions will rise during its execution. Here are the 3 major ones where 3Biotech can help:
- How many CDMOs should I reach during my screening? What kind of CDMOs should I contact? Where in the world? How long will it take to send the RFI?
- 3Biotech has a database of CDMOs in Europe and rest of the world with a business contact. The screening + sending of RFI of ~15 of them will take no longer than half a day,
- How to write a relevant RFP,
- Based on their 30+ years of experience in pharmaceutical manufacturing, our consultants know which mandatory information should be added to an RFP making the commercial offer as precise and making the comparison as objective as possible,
- How to assess the proposals and select the right CDMO after all?
- This selection is mainly based on the selection criteria defined at the very beginning of the process. It is again based on our consultant’s expertise, customer feelings but also on 3Biotech track records with the CDMO.
Author: Matthieu Bernardi