Choosing the best Contract Manufacturing Organization (CMO) to prepare an API for manufacturing is not rocket science if you know the right questions to ask. Our continuing series on how to select a CMO covers evaluating manufacturing, analytics, technology transfer, and quality assurance capabilities.
While the latest technology and equipment are important, the technical team is a key differentiator when reviewing potential CMOs. In the long run, a highly functioning, well equipped, productive, and experienced technical teams will give you the highest chance for success at the best possible project cost.
How do you find the right team? Evaluating the R&D team of a prospective CMO can be intimidating. That’s especially true if you don’t have a strong technical background—or have more of a business than a technical background. The good news is that the CMO should have all the answers. You just need to ask the right questions about the people, their analytic and management support, and their equipment. The rest of this article looks at those key questions.
There are six key attributes to look for in your CMO’s technical R&D team.
In this and subsequent articles we’ll provide a framework for evaluating the people at the CMO who will be responsible for manufacturing your Active Pharmaceutical Ingredient (API).
We’ll start with an easy but telling question:
In any organization turnover is normal, something to be expected. People choose to move closer to—or further away—from family. A spouse gets a coveted job elsewhere, or a spouse loses a job and suddenly the cost of living is too high, etc. etc. There are countless very legitimate reasons people leave.
Turnover is not necessarily a bad thing. It can actually be very good overall for a growing company, bringing in new talent better suited for the organization.
However, due to the highly technical nature of drug substance development, there is a great deal of institutional knowledge that is acquired by the people who perform the R&D work.
Even when experiments are meticulously documented, no matter how hard you try it’s simply impossible to document everything. And because laboratory development work is so extremely experiential, it is often difficult to transfer from one person to another.
So if the technical lead on your program should all of sudden give two weeks’ notice, it could prove to be very disruptive. Not to mention that it will take time for a new person to come up to speed on the project, impacting productivity and costs.
Therefore it’s a good sign when the R&D team has a lower turnover rate than the rest of the organization. It means that they like working there, feel they are compensated well, and are consistently challenged technically. In this type of work environment it is less likely people will get up and leave in the middle of your project.
There’s another factor at work that has helped PCI Synthesis maintain a low turnover rate, and that is management. Years ago, if we had a process chemist who had done a very good for several years, we promoted that person to the position of Technical Manager. The role of the Technical Manager was to oversee a small group of PhD chemists working on a couple of projects.
That is how most CMOs are organized.
It didn’t work for us.
Instead, we adopted a flat management structure, one that better creates a collegial and collaborative work environment. At the same time it operates more efficiently and more cost effectively.
We removed the middle layer of management and stretched the job of the Technical Director to oversee the department. We trained people so that they could be more independent, and paid them more. They can still get help and support from the Technical Director or their colleagues whenever they need it.
With the political nonsense gone (OK, greatly diminished), productivity soared.
Technical teams that can offer suggestions on specific operational practices that increase process efficiencies and/or decrease the costs of goods demonstrate innovative thinking.
Process chemistry is about solving one problem after another. You do literally hundreds of individual experiments to see how the process behaves, tweaking and changing process parameters to get the desired end result.
The truth is that when you start your project you truly do not know what technical challenges lie ahead. A question to ask is this:
Another example of innovation is a CMO that is able to decrease the number of process steps for a product, with a concomitant increase in overall yield. Ask: Have they done this before?
You hope for the best but you should expect many unexpected challenges during the development and scale-up of your process. The technical management of this group should be able to articulate particular insight on where the technical challenges could arise and what solutions they expect to propose for your specific project. This should not be their first rodeo!
The technical R&D team will be the lead consultants for your project. Therefore look for a spirit of offering suggestions for improvement and solutions to solve problems. It should appear to be second nature.
In choosing a CMO, the technical R&D team that will work on your project is critically important. You can address job satisfaction at the CMO indirectly by asking about turnover rate – the lower, the better. These are the people who will need to solve process problems daily, so determine how innovative they are by asking for examples of how they have reduced impurities and improved processes. Ask the right questions and you’ll have R&D covered.