How to select the best CDMO for your needs?

In our last post, we talked about the CDMO importance (Why do we need a CDMO?). Now that it is clear, we need to understand what the key considerations are to choose the right CDMO for your process. Choosing a CDMO is something highly strategic and delicate, since the wrong choice can negatively impact the project. And when talking about a small pharmaceutical company with limited time, resources and budget, this mistake can be even more critical.  

Based on its criticality, some biopharmaceutical companies may find themselves unprepared when it comes to beginning the search. To avoid a possible mistake, practicing a due diligence process during the CDMO selection may be essential. Doing this you can ensure the selection of a partner whose business strategy not only aligns with yours but also provides a pathway for long-term success and stability.  

But what attributes should we consider in the due diligence? See some tips below. 

1. 1. WHAT QUALITY SYSTEMS DOES THE CDMO HAVE IN PLACE? A CDMO with an appropriate on-site quality assurance (QA) group should have a manual the outlines their quality strategy and should be able to demonstrate they are able to handle any necessary investigations and/or resolve any deviations. If the CDMO is outsourcing or contracting QA, it may take longer to release the product. 

2. 2. HOW IS TROUBLESHOOTING MANAGED DURING SCALE-UP? For CDMOs with a formal process development and/or technology transfer group, troubleshooting activities can be resolved on-site. If the CDMO does not have a process development or technology transfer group, the alternative is for them to take issues back to the client to handle themselves. Either way, it is important to know how issues with your product will be handled. 

3. 3. CAN ANALYTICAL TESTING BE DONE ON-SITE? CDMOs may outsource all or some analytical testing to a third party, such as sterility, bioburden, and endotoxin, so it is essential to understand how in-house and outsourced testing strategies affect the release timeline for a product. It is also important to know if analytical development is available on-site should these methods need to be developed or optimized. The advantage of having analytical development at a CDMO is that the technology transfer to their QC group will likely be a smooth transition, rather than transferring it from either another company or from your company directly. An analytical development group at the CDMO can also quickly provide troubleshooting services when they are needed. 

4. 4. THE CDMO CAN PRODUCE THE AMOUNT OF MATERIAL YOU NEED FOR YOUR PROJECT? The CDMO you select must have the capacity to produce the amount of product you need. So, it is important for you to have determined this estimation in advance to be able to evaluate your partner's production capacity. 

5. 5. WHAT IS THE CDMO TIMELINE? Along with scale, it is also important to know that your target dates for starting the project and when you need to have the final product converges with the CDMO timeline. Often, sponsors taking their first drug from a pre-clinical to the clinical trial stage may not have a full understanding of all the factors required for cGMP manufacturing and release of final product for clinical trial. Feedback from the CDMO and an explanation of the steps required for the project scope of work will be useful for the drug sponsor to assess if the proposed timeline is achievable. 

6. 6. WHAT IS THE CDMO FLEXIBILITY? Each project is unique, and to accommodate a range of customers, products, and processes, CDMOs must be flexible in not just how they work, but how they collaborate; adapting to a customer’s quality management systems, working with their various teams, or learning to communicate according to their specific needs are all core to achieving flexible, optimized workflows. 

7. 7. IS THE CDMO COST-EFFECTIVENESS? When it comes to cost-effectiveness, CDMOs should be positioned to leverage process analytical testing (PAT), including in-machine inspections, verifications, and non-destructive testing to control expenses. Being able to verify, using data, that an assembly is correct throughout the course of a process rather than at the end reduces risk at final release testing, marrying quality and cost by eliminating waste and lessening labor. Understanding the rationale behind the price tag is important to choosing the most cost-effective CDMO rather than the cheapest one. 

Briefly, a general de-risking CDMO approach flows like this: step one will be a general inquiry to the CDMO to determine if they have the capabilities to execute your product’s manufacturing process. If there is a potential fit, then a confidentiality agreement will need to be developed and agreed on before the sponsor and the CDMO can discuss the process and any development needs in detail. Prior to scheduling a technical call, you will want to send a packet of information describing the product, the processes used in production, and the scale and timeline of production that you anticipate. Typically, the CDMO’s Business Development group forwards this information to the technical staff and scientists. Expect to allow at least a week for review so they can accurately assess the scope of the project and prepare requests for additional information. In parallel, it is also important you make a short (two- to four-hour) follow-up visit to tour their facilities. This allows you to perform due diligence and feel comfortable about the people and the organization. 

By evaluating a CDMO’s track record, understanding its internal processes, and gauging its willingness to conform to the processes and procedures of its clients, pharmaceutical companies can have more information for decision making and thus obtain better outcomes. 

References: 

1. 6 CDMO Selection Tips From An Experienced Start-Up 

1. Key Considerations When Choosing A CDMO 

1. Preparing For Your CDMO Selection Process