6 CDMO Selection Tips From An Experienced Start-Up

By Louis Garguilo, Chief Editor, Outsourced Pharma

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Does your process to select a CDMO emerge from within and without?

Ryan Crisman, cofounder and Chief Technical Officer, Umoja Biopharma, Inc., says it should.

“To begin with, it's always important for your selection model to have an internal expert who can ‘fact check’ the CDMOs,” Crisman advises.

Featured recently in these pages, Umoja is a clinical-stage company advancing a new cell-therapy approach to immunotherapy, specifically for solid tumors.

The company also has a small-molecule platform. Crisman says cofounder (Phil Low, Co-Chair of Umoja’s scientific advisory board; Presidential Scholar in Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry at Purdue University), had been doing small molecule research for decades. He provided a contact to take the lead in assessing CDMOs.

“Al Ritter came on as a consultant with his 35 years of experience in development and manufacturing of small molecules. He went out and did all our initial service-provider assessments,” says Crisman, who himself is an experienced biopharma facility professional.

“Al was so valuable we ended up hiring him full time. He oversees our small molecule pipeline development.”

Umoja was established in , and a piece of Ritter’s early advice proved prescient:

For a U.S.-based company, keep partners close to home – meaning within North America.

That cornerstone guidance helped Umoja avoid the worse of the COVID and supply-chain challenges that soon transpired. “It was critical for control of our supply chains,” says Crisman.

Ritter also set an example for Umoja (and now Outsourced Pharma readers) to follow.

Crisman says:

“Al goes into CDMO discussions thinking of building a strategic relationship, and trying to understand, ‘What is the mission of this CDMO?’

“He’s taught us we must ensure we aren’t just a cog in the wheel, another revenue stream. He clarifies whether the CDMO is actually interested in troubleshooting, and working collaboratively.”

However, Crisman clarifies, “This isn’t a knock on those who aren’t. CDMOs know what is good for their business model, and what is not, just like the prospective client should.”

Obtaining this assurance of alignment is critical.

As well as advancing its own pipeline, Umoja’s mission includes potentially going out to CDMOs with designs of having some of those providers adopt Umoja’s novel approach and technology for lentiviral vector development.

They’ve been picking CDMOs as service providers, and soon as technology partners.  First, Umoja is perfecting and de-risking that technology by building out its own facility.

Once that is accomplished, it will then require an intricate transfer to CDMOs, close cooperation and troubleshooting, and further learning together.

How will Umoja know which of these CDMOs will fit that bill?

Crisman says Ritter (and the experience of others in the company) has taught them if you ask the right questions, “you can actually figure out quickly what type of CDMO they are.”

“Already, we’ve learned there are really good, established CDMOs out there that want to be a partner, and some that see you as a dollar sign and prioritize – or de-prioritize – based on the size of the company. Those don’t last very long.”

Which brings us to our first four tips:

1. Have an internal outsourcing expert (who can be a consultant); ensure the entire company learns from them.
2. Stay as close to home as possible to mitigate supply-chain (and other) risks.
3. Verify the CDMO’s “mission”; obtain an assurance of alignment with your goals.
   1. Accomplish this initially by asking the right questions, and thinking in terms of strategic partnerships.
4. When necessary – considering all factors, e.g. funding, external expertise (or lack of), etc. – build your own facility as a component of our strategic plans.

Below we’ll describe two more tips:

5. Select CDMOs based on your specific program needs, and their specific capabilities
6. Verify CDMO track records with others; meet directly with CDMO project-team members to verify skills and longevity.

Who Passes The Exam?

In the development space, says Crisman, for us it’s been “quite a mix of big, small, new and more experienced CDMOs – with that caveat they are all located in North America.”

Contact us to discuss your requirements of Small Molecule CDMO. Our experienced sales team can help you identify the options that best suit your needs.

And not the relationship kind, but the actual chemistry involved with Umoja’s programs helps drive these selections. “We found the smaller shops had more of an established research arm ready to invest the time and effort to help us understand the chemistry,” he says.

In some cases, these smaller – more focused and specialized – CDMOs have unique analytical tools, “so we could look at the chemistry from different angles.”

Conversely, Crisman says, “The big CDMOs, especially during the recent supply-chain challenges, tend to have the upper hand in regard to more access to vital items, such as vials for drug products.”

So why not contract to get the best of both breeds? To de-risk various aspects of the outsourcing process, that’s what Umoja has been looking to do.

But in all cases, it’s been a solid consideration of the internals at Umoja that drive where and with whom to externalize.  

Next, Crisman avers, when it comes to comparative price-shopping, “the entire CDMO world is highly competitive. The pricing ranges tend to be in the same ballpark.”

Therefore, price alone won’t ferret out many CDMOs from others – which adds importance to these enumerated tenets of the Umoja outsourcing strategy.

(And when there are notable price discrepancies, it’s important to learn why. Perhaps the CDMO didn’t fully understand the project, or you aren’t understanding all that is essential for ultimate success. It’s worth following up.)

So with price off the table (relatively), Crisman knows “it ends up with sponsors having to carefully access a CDMO’s history.”

One way to understand that track record is to independently ask other sponsors who have worked with a CDMO; another is to seek references directly from the CDMO – and follow up closely on those. (Another is to access our CDMO Leadership Awards, presented each year in April.)

Within that CDMO history, skilled worker availability and retention should be carefully noted; you can learn a lot by directly meeting those who would be working with you.

“The skilled-worker profile is something we are hyper-focused on,” says Crisman.

That … and all of the above.

The biopharmaceutical industry has witnessed a significant surge in the number of therapeutic molecules in development, leading to a corresponding increase in the number of contract development and manufacturing organizations (CDMOs). This growth has created a competitive landscape where pharmaceutical companies must carefully evaluate and select the right CDMO partner to ensure the success of their projects. In this article, we will delve into the key criteria for selecting a CDMO, highlighting the essential factors to consider and the importance of effective communication and cultural fit.

Your Drug’s Development Stage

The stage of your drug development is a critical factor in selecting a CDMO. It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinical research. This understanding will help you identify the right CDMO partner with the necessary expertise and capabilities to support your project.

Range of Services

The range of services offered by a CDMO is another vital criterion. Pharmaceutical companies should consider whether they need a CDMO that can handle all aspects of drug development, from pre-formulation to commercial manufacturing, or if they will engage multiple vendors for different stages of the process. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management.

Transparency Regarding Costs

Understanding the costs associated with working with a CDMO is crucial. Pharmaceutical companies should create a detailed list of questions for potential CDMO partners, inquiring about the final costs, including any guessed expenses and planned costs. This transparency will help avoid unexpected financial challenges and ensure that the project stays within budget.

Speed and Quality of Development and Production

The speed and quality of development and production are critical considerations in selecting a CDMO. Pharmaceutical companies should evaluate the availability and capacity of potential CDMO partners, inquiring about their experience, capabilities, and current workload. This understanding will help identify potential bottlenecks, changeovers, and transfer times, particularly when engaging with multiple CDMOs.

Expertise and Experience

The expertise and experience of a CDMO are vital in ensuring the success of a project. Pharmaceutical companies should look for CDMOs with a proven track record of working with various molecules and pharmaceutical companies. This experience translates into practical solutions based on a wealth of knowledge, enabling the CDMO to identify potential issues during process development and scale-up.

Regulatory Compliance and Quality Assurance

Regulatory compliance and quality assurance are essential aspects of CDMO selection. Pharmaceutical companies should evaluate a CDMO’s compliance with industry standards and regulations, ensuring that they have a robust quality assurance system in place.

Technological Capabilities

The technological capabilities of a CDMO are critical in supporting the development and production of complex pharmaceutical products. Pharmaceutical companies should assess a CDMO’s facilities, equipment, and scientific and technical teams to ensure they can handle the specific requirements of their project.

Communication and Cultural Fit

Effective communication and cultural fit are often overlooked but crucial aspects of CDMO selection. Pharmaceutical companies should engage with a CDMO’s current clients, consultants, and colleagues to gain deeper insights into their working style, adherence to quality standards, and potential challenges they may have faced. This peer-to-peer perspective offers invaluable information, empowering pharmaceutical companies to make an informed decision.

Assessing the CDMO’s Capacity and Workload

Understanding a CDMO’s capacity and workload is vital in ensuring that they can handle the amount of work required by the project. Pharmaceutical companies should inquire about a CDMO’s current workload, availability, and potential bottlenecks to avoid any delays or capacity issues.

Creating a Checklist

Creating a comprehensive checklist is essential in evaluating potential CDMO partners. This checklist should include the key criteria mentioned above, ensuring that pharmaceutical companies have a thorough understanding of a CDMO’s capabilities, expertise, and cultural fit. By constructing such a checklist, pharmaceutical companies can create frameworks, master service agreements, and quality agreements that favor fluid communication and alignment of business objectives.

Conclusion

Selecting the right CDMO partner is crucial to the success of a pharmaceutical project. By considering the key criteria outlined above, pharmaceutical companies can ensure that they find a CDMO that meets their specific needs and requirements. Effective communication, cultural fit, and a comprehensive checklist are essential tools in this evaluation process, enabling pharmaceutical companies to make informed decisions and minimize risks.

References

For more information, please visit Synthetic Chemistry.

1. Ajinomoto Bio-Pharma Services. (, March 6). Preparing For Your CDMO Selection Process. Contract Pharma. Retrieved from https://www.contractpharma.com/issues/-03-01/view_features/preparing-for-your-cdmo-selection-process-/
2. Bioprocess Online. (, March 13). A CDMO’s Checklist For Prospective Clients Part 1. Retrieved from https://www.bioprocessonline.com/doc/a-cdmo-s-checklist-for-prospective-clients-part-1-
3. Ascendia Pharmaceuticals. (, July 12). CDMO Selection Criteria: 4 Factors to Consider. Retrieved from https://ascendiapharma.com/newsroom//07/12/cdmo-selection-criteria-4-factors-to-consider
4. Renejix. (n.d.). Top 10 Factors to Consider When Choosing a CDMO. Retrieved from https://renejix.com/criteria-for-cdmo-selection/
5. Bioprocess Online. (, November 29). Create The Correct Checklist To Land The Best CDMO. Retrieved from https://www.bioprocessonline.com/doc/create-the-correct-checklist-to-land-the-best-cdmo-