Chamow & Associates is pleased to present a blog series detailing best practices for working with a contract development and manufacturing organization (CDMO). This series is intended to provide a potential sponsor company with sound advice in finding finding and choosing the right CDMO for its product development and managing that CDMO to perform to the company’s expectations. We continue our series with – “Determining priorities when looking for a CDMO.”

Creating a Target Product Profile

The foundation for CDMO selection begins with creating a Target Product Profile (TPP). This is an essential roadmap to profile the product—what qualities define it, how it will be administered and in what clinical setting it will be used. The TPP should define characteristics such as a product description, indications and usage, dosage and administration, dosage forms and strengths, manufacturing technology and process, scale of production, and storage condition. The TPP is a living document that will change as the development plan evolves, and it serves as your company’s guideline throughout the process. It will aid in matching priorities to the extent that they are known. We recommend that you take a look at the FDA’s guidance document (March 2007) on writing a TPP.

Understanding Priorities

For your project and your company, there are three major factors that need to be prioritized before selecting a CDMO. They are:

· Quality

· Timeline

· Cost

Quality is the foremost priority. We are making pharmaceuticals, and this cannot and should not be comprised. As a rule, the two factors of timeline and cost vary inversely, so you must decide whether timeline or cost is your second priority. If timeline is most important, expect to pay more for the needed services. If cost is your second priority due to limited cash flow, you may need to be flexible on timeline. Even so, as a sponsor, you may believe that you have a failsafe product which turns out to be not so failsafe upon scale-up. This could lead to both increased time and cost. Note also that CDMOs vary in technological competencies and abilities. It is important to understand what these are for each candidate CDMO and to select ones that are best matched for your priorities.

Once a TPP is in place, you can then begin evaluating CDMOs and what they offer. Develop a list of candidate CDMOs. This can be created on your own or you may utilize a consulting group with solid expertise to assist in this process.

Creating a Like-to-Like Comparison

The information in the TPP enables you to draft a request for proposal (RFP). The RFP should include scope of work and timeline. A single RFP is needed to describe your project, as the same RFP can then be issued to the CDMOs identified as good candidates for your project needs. Our recommendation is to send the RFP to 6-8 CDMOs to get a suitable return of proposals, as not all CDMOs will respond.

CDMOs have business development teams who receive these RFPs and draft proposals in response. You should allow 3-4 weeks for receipt of proposals, which will be sent back to you by the due date that you specify in your RFP. When they are received, since all CDMOs are responding to the same RFP, you can extract similar information from each proposal into a single spreadsheet. This allows you to make a straightforward, like-to-like comparison between CDMOs.

Using this comparison spreadsheet, CDMOs can then be ranked based on weighted criteria reflecting the sponsor’s priorities, and a decision that considers risk according to quality, timeline, and cost can be made.

Chamow & Associates assists companies to develop biologics for clinical testing and welcomes your inquiry. Subscribe to the Chamow & Associates blog to receive notification for new posts, including future topics for this CDMO Series.