Choosing the right CDMO partner for your project can make your manufacturing venture an absolute dream, or your worst nightmare. Once you are at the height of manufacturing, it is not the time to juggle misunderstandings over timelines, critical milestones and project goals.
At this point it is assumed that you have evaluated your project and decided on your internal requirements. You have carefully crafted your RFP and are now ready to start down the path to vendor selection–which companies will get the chance to bid on your business?
Companies have taken a variety of approaches in choosing companies to contact. Everything from calling a friend in the industry for a reference to the “shotgun” approach of cold calling everyone they can find. Which is the best choice? Neither. What is the best option? It depends. There is no one size fits all recipe for selecting a partner.
Approach #1 – Refer a Friend
This is the path most commonly taken by somebody at a smaller organization with the new responsibility of finding and managing third party research and manufacturing resources. They will call a friend and the conversation might go something like this.
“Hi John, I need to find a vendor for my new project. Can you recommend a good CDMO?”
“Sure Fred, I used XYZ on my last project and they did an excellent job.”
“Thanks John, I will give them a call.”
Then Fred calls XYZ, gets a confidentiality agreement in place and eventually a contract with XYZ is signed. He doesn’t even bother to go to a second CDMO as he trusts his friend. Unfortunately, the project run smoothly. XYZ fails to meet the prescribed timeline, quality or financial targets set forth at the beginning of the project. Fred is mad at XYZ and wonders how his friend could steer him so wrong. Guess they won’t be talking anytime soon.
Approach #2 – Shotgun
Having been burned on the last project Fred is determined not to make the same mistake on his next project. When the next project comes up, Fred takes a look at the latest trade show directory, eliminates several on the basis of arbitrary criteria and starts the process of getting a CDA from thirty different CDMOs. After getting the CDA in place and sending out his RFP ten of those companies send Fred off with a polite thanks but no thanks–the project is not a good fit and they will not be submitting a proposal. Not bad Fred thinks, at least I am getting 20 proposals. Over the next couple of weeks he fields a series of questions, often the same ones in different formats from several CDMO. As if that wasn’t annoying and time-consuming enough, imagine his frustration when five CDMOs don’t bother to submit a proposal in time, leaving him 15 proposals of various levels of detail that he needs to review and summarize. Fred is on the hot seat now as management wants to know who has been chosen. He shortlists a few and picks one, once again with less than desirable outcomes.
As the above scenarios clearly demonstrate the major pitfalls of two approaches, you may be wondering, what is the best way to approach vendor selection? The simple answer is that you need to find the CDMO partner that has the best capacity, technology, resources, quality system and financial match for your needs. Doing your homework up front will go a long way to avoiding partnering with someone that will struggle to meet your goals and will also help you to eliminate the need to throw your RFP against the proverbial wall to see who sticks shotgun approach.
While there are certainly a multitude of criteria that can be evaluated, identifying and avoiding the key mismatches will go a long way toward getting your project completed. Key questions need to address the following: quality systems, capacity and technology.
Probably the most important question to ask of a potential CDMO is: are the quality systems sufficient? If you need cGMP manufacturing you can eliminate all of the ISO type contractors. Likewise, if you are looking at potential regulatory starting materials, why pay the premium for cGMP production if it isn’t needed? Search the FDA database for warning letters to identify past quality problems. Most reputable manufacturers will dedicate an entire page to their recent regulatory inspection history. This is not a substitute for a quality audit, but the goal at this early stage is to exclude potentially bad fits from your list.
Having reduced your pool based on quality information, generally, the next step is to determine if potential CDMOs have the capacity to handle your project. This can get a little tricky at times, because you may only be able to determine if they have the reactors and equipment, not availability. If you are looking to eventually prepare 10 MT of drug substance in a given year you probably would want to avoid a smaller CDMO with limited capacity, or at the very least realize that you will likely need to transfer your project in the future.
The final step in determining who will receive your coveted RFP is to evaluate the CDMO technology for your project. A thorough understanding of your project requirements is a necessity at this point. If you are working with a highly potent compound, you will need to limit your search to those companies that are truly experts in that field. Add in that you may require energetic chemistry, cryogenic conditions or lyophilization and the potential pool gets much smaller.
If you have directed your search for a CDMO with the guidelines above you should be able to generate a list of 5-6 CDMOs that could potentially execute your plan and deliver high-quality product on time and under budget. These are the CDMO that should be contacted to execute your confidentiality agreement and submit proposals. From there you can compare them, make a short list, visit one or two and finally make a decision.
Moral of the story? Don’t be Fred. Direct your search for the best CDMO for your project with the guidelines of quality systems, technology and capacity in mind and you will ensure that your project is successful and on target. Fred is a fictional representation. Any semblance to a real person is purely coincidental.