Determine Your Priorities to Finding the Right CDMO
This article is the second part of our “Best Practices in the CDMO Selection Process” series, through which we intend to provide sound advice to agile biotech companies in identifying and selecting the right Contract Development and Manufacturing Organization (CDMO) for advancing the development of their product(s), in conjunction with successfully managing a chosen CDMO to meet the company’s expectations.
In this article, we will detail the best practices for working with a CDMO to ensure the success of your product development. After having identified the need for engaging a CDMO, the next steps would entail the evaluation of your options. Before looking at a CDMO’s capabilities, it’s important to assess your priorities as the sponsor company.
Creating a Target Product Profile or TPP
The foundation for CDMO selection begins with creating a Target Product Profile (TPP). This is an in-depth roadmap of your product—what qualities define it, how it will be administered and what clinical setting it will be used in. The TPP should include:
- Product description
- Indications and usage
- Dosage and administration
- Dosage forms and strengths
- Manufacturing technology and process
- Scale of production
- Storage condition
The TPP is a living document that evolves alongside the overall product development plan and serves as your company’s guideline throughout the process. It aids in matching priorities to the extent that they are known. We recommend a review of the FDA’s guidance document from March 2007 on writing a TPP for best practices.
Understanding and outlining your Priorities
Before selecting a CDMO for your project or company, you need to define three major factors:
Quality is of top priority when it comes to manufacturing pharmaceuticals and cannot be compromised at all. Generally, timeline and cost vary inversely, so a decision needs to be made as to your second highest priority. If the timeline is of greater importance, expect to pay more for the requested services. If cash flow is limited and cost is of second priority, you may need to be flexible on the timeline.
Keep in mind that as a sponsor, you may believe that you have a failsafe product; however, when scaled, it may prove otherwise. This can lead to both increased time and cost. CDMOs also vary in technological competencies and abilities and it’s important to understand the strengths and limitations of each CDMO in order to select the ones most suitable to match your priorities.
Once a TPP is in place, begin your evaluation process by developing a list of candidate CDMOs. Create your own list or enlist the assistance of a consulting group with solid expertise to assist in finding suitable candidates.
Creating a like-for-like comparison
Next, draft your Request for Proposal (RFP) using the information contained in your TPP, defining the requested scope of work and associated timeline. A single RFP is needed to describe your project and that RFP can be issued to multiple CDMOs previously identified as suitable candidates for your project. Our recommendation is to send the RFP to 6–8 CDMOs, as not all CDMOs will respond.
CDMOs have business development teams in place, who receive RFPs and draft proposals in response. Allow 3–4 weeks for receipt of proposals, which will be returned to you by the due date specified in your RFP. Since all CDMOs are responding to the same RFP, you can pull similar information from each response proposal into a single spreadsheet to generate a straightforward, like-for-like comparison.
Using this comparison spreadsheet, rank your candidate CDMOs using weighted criteria reflecting your top priorities while also considering risk to quality, timeline and cost. This comparison and knowing what to look for in the right CDMO will help you make the right selection.