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How to Choose the Right CDMO For Your Pharmaceutical Project- Part One: Will They Deliver?  

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Choosing the right Contract Development and Manufacturing Organization (CDMO) for your pharmaceutical project is a crucial decision that can impact the success of your project (and maybe your career). With so many options available, it can be difficult to know where to start. In this blog post, we will take a closer look at some of the key factors to consider when choosing a CDMO for your pharmaceutical project. You’ll want to answer two main questions (and a lot of more detailed questions).  

  • Will they deliver a quality product on time?  
  • Will they be good to work with?  

Will They Deliver?   

Technical Expertise  

This point is obvious, but bear with me, OK?   

Look for a CDMO that has expertise in your specific area of focus. Whether you’re developing an immediate-release tablet, a multiparticulate capsule, or a lyophilized powder for injection you’ll want to work with a provider that has a track record of success in your particular niche.  

You’ll want a CDMO with experience in developing and manufacturing pharmaceutical products similar to yours, at the scale you need, and with a team of experts who have the necessary technical knowledge and experience to meet your needs.   

What evidence is there that they have this? Can they point to specific products or publications that demonstrate their success and expertise?  

If in doubt, take a cue from Elon Musk, and ask how they solved a problem. The people who really solved it will know the details. The people who were just nearby when it was solved will quickly stall out in the conversation.  

Organizational Expertise  

Expertise doesn’t just apply to the technical team, though. The obvious teams to look at here are the formulation and process scientists and the analytical chemists, people who will directly impact the success of your project, and yes, they’re the first stop in your due diligence.   

Don’t stop there, though. There are numerous others who play a crucial role. Think about project management, quality assurance, supply chain, facilities, and others.  

Specific technical expertise and experience are vital, but how much fun will your project be if the QA team isn’t familiar with the kind of product you’re trying to make, or the supply chain group doesn’t have relationships with the key material vendors for your product?   

Organizational competence matters just as much as technical excellence. Make sure your chosen CDMO has a complete team of people with the necessary skills and experience, not just in the technical things you need, but also in the all-important indirect roles.  

An established CDMO will have a wealth of knowledge and experience surrounding projects similar to yours, which can minimize risk and streamline the development process. Investigate their case studies, success stories, and client testimonials to get a sense of their capabilities and accomplishments.  

Facilities and Equipment  

Another important factor to consider is the CDMO’s facility and equipment. Look for a CDMO with a clean and well-maintained facility that meets regulatory requirements and is equipped with the right technology and equipment to handle your project needs.  

Make sure they have the capacity to handle your project now and in the future. Finding a good CDMO, setting up the relationship, and getting your project moving is a lot of work. You’ll face a lot more work (and risk) if you have to move your project to a new CDMO every time there’s a change in scale or phase of development.  

Quality and Compliance  

Ensure that the CDMO you choose has a strong track record of regulatory compliance. What healthcare authorities have audited them? How recently? What was the outcome?  

If you’re aiming to have clinical supplies manufactured or packaged, you’ll want to do a quality audit of your own. In the early stages of your due diligence, you can review their inspection history, ask about their policy on client audits, and otherwise get a feel for their quality philosophy.   

Every company has a different appetite for risk. Remember, though, that a CDMO has to balance risk amongst numerous client programs, and that compliance risk is never contained within a single project. If they’re willing to take a big risk for you, it’s almost guaranteed that they’ve taken similar risks for other clients and any one of those risks could impact your program, too.  

Cost and Timeline  

Of course, you want a CDMO that can provide you with a cost-effective solution that meets your timeline requirements, while still delivering high-quality results. Everyone wants that. CDMOs even want to deliver that.  

Will they be able to deliver a quality product on time? At what price? If there’s a voice in the back of your head saying it’s too good to be true, listen to it. You must strike a balance between cost, speed, and quality.  

This is where it’s essential to be realistic and specific. To a point, you can make a project go faster by providing more attention and resources (expensive), by reducing scope, or by cutting corners (risky). The adage that “an ounce of prevention is worth a pound of cure” holds true in pharmaceutical development, too.   

Here’s a tricky question. What’s more expensive: investing double the time and money in development and clinical supplies manufacturing to make sure your product is manufacturable, stable, and performs properly, or repeating your stability and clinical studies later when you have to change the formulation to fix a problem you could have detected and fixed earlier?  

Richard Sidwell, Ph.D.
Senior Vice President and Chief Scientific Officer
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