What is a CDMO and what to look for in a partner

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}); </script> </div> </div> </div> </header> <div class="responsivegrid aem-GridColumn aem-GridColumn--default--12"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-hero aem-GridColumn aem-GridColumn--default--12"> <div id="hero" class="pb-5 pt-5 hero-no-hr "> <div class="container-fluid container-lg"> <h1 class="h1 d-inline-block " style="color:#58595B;">What is a CDMO? </h1> <h2 class="h2 d-block" style="color:#58595B;"> Seven things to look for in a quality CDMO partner </h2> <div class="mt-2"> July 19, 2023 by <b>Staff writer</b> (9 minute read) </div> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> </div> </div> </div> <style type="text/css"> .cmp-hero #hero h1 span::before { background-color: #58595B; } #hero { min-height: 350px; } </style> <style type="text/css"> #hero { background-image: url('/content/dam/patheon/global/hero-images/solved_with_heart_and_science.png'); background-position: center center; } </style> </div> <div class="cmp-well aem-GridColumn aem-GridColumn--default--12"> <div class="well " id="well-1523980059"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--small--12 aem-Grid--default--12 aem-Grid--xsmall--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--12 aem-GridColumn--offset--default--0 aem-GridColumn--offset--medium--0 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--default--8"> <div class="cmp-container-inner " id="container-580520627"> <div class="aem-Grid aem-Grid--8 aem-Grid--small--12 aem-Grid--default--8 aem-Grid--xsmall--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--default--8"> <div class="cmp-container-inner " id="container-551763199"> <div class="aem-Grid aem-Grid--8 aem-Grid--small--12 aem-Grid--xsmall--12 aem-Grid--default--8 aem-Grid--medium--12 "> <div class="text aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--offset--default--0 aem-GridColumn--small--6 aem-GridColumn--offset--medium--0 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--xsmall--6 aem-GridColumn--offset--small--0 aem-GridColumn--default--6 aem-GridColumn--medium--6"> <div id="text-99bf414a45" class="cmp-text list-style-bullets"> <p><b>Category</b> | <a href="https://www.patheon.com/us/en/our-capabilities.html">CDMO Services</a></p> </div> </div> <div class="sharing aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--offset--default--0 aem-GridColumn--small--6 aem-GridColumn--offset--medium--0 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--xsmall--6 aem-GridColumn--offset--small--0 aem-GridColumn--medium--6 aem-GridColumn--default--2"> <div class="sharing-cmp text-end"> <a href="#" target="_blank" class="sharing-linkedin-link" data-platform="linkedin" rel="noopener"> <i class="fa-brands fa-linkedin"></i> </a> <a href="#" target="_blank" class="sharing-twitter-link" data-platform="twitter"> <i class="fa-brands fa-x-twitter"></i> </a> <a href="#" target="_blank" class="sharing-email-link" data-platform="email"> <i class="fa-regular fa-envelope"></i> </a> </div> </div> <div class="cmp-container aem-GridColumn--small--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--default--8"> <div class="cmp-container-inner " id="container-282880353"> <div class="aem-Grid aem-Grid--12 aem-Grid--small--12 aem-Grid--xsmall--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="custom-html-cmp aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--12 aem-GridColumn--offset--default--0 aem-GridColumn--offset--medium--0 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--default--12"> <div style='padding-top: 10px;padding-bottom: 33px;'> <hr style='margin:0;'> </div> </div> </div> </div> <style type="text/css"> #container-282880353{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-282880353 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--8"> <div class="cmp-container-inner " id="container-1333437438"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text aem-GridColumn--default--none aem-GridColumn aem-GridColumn--default--11 aem-GridColumn--offset--default--0"> <div id="text-4078675870" class="cmp-text list-style-bullets"> <p>From discovery to commercialization, drug development and manufacturing is a complex, years-long process that typically involves multiple rounds of research, testing, and regulatory approvals. While pharmaceutical companies can choose to venture out alone, they can also opt to have help. CDMOs, or contract development and manufacturing organizations, are strategic partners that pharmaceutical companies can work with to bring their medicines to market.</p> <p>That said, there are several considerations to take into account when picking the right CDMO company to partner with on the drug development and manufacturing journey. In this blog, we explore seven key attributes to look for in a CDMO partner, so you can feel fully confident in your decision-making process:</p> <ul> <li>Industry credibility</li> <li>End-to-end support</li> <li>Proactive risk mitigation</li> <li>Overcommunication</li> <li>Good project management</li> <li>Scalability</li> <li>Trustworthiness</li> </ul> </div> </div> <div class="image aem-GridColumn--default--none aem-GridColumn aem-GridColumn--default--12 aem-GridColumn--offset--default--0"> <link rel="stylesheet" href="/etc.clientlibs/multisitecommons/clientlibs/clientlib-image.min.css" type="text/css"> <script src="/etc.clientlibs/multisitecommons/clientlibs/clientlib-image.min.js"></script> <script src="/etc.clientlibs/multisitecommons/clientlibs/vendor/magnificpopup.min.js"></script> <div data-cmp-is="image" data-cmp-lazythreshold="0" data-cmp-src="/content/patheon/us/en/insights-resources/blog/what-is-a-cdmo/_jcr_content/root/responsivegrid/well_copy_copy_copy/container/container/container_copy_65924/image_1297367049.coreimg{.width}.jpeg/1689266928545/what-is-a-cdmo-and-considerations-in-a-partner.jpeg" data-asset="/content/dam/temp_patheon/blogs/what-is-a-cdmo-and-considerations-in-a-partner.jpg" data-asset-id="1dac7f21-0552-40a1-9cf8-4d6c7bdf3ccd" data-title="Seven considerations for choosing a quality CDMO partner" id="image-88b177529e" class="cmp-image expandable false " itemscope itemtype="http://schema.org/ImageObject"> <img class="expand-icon" src="/etc.clientlibs/multisitecommons/clientlibs/clientlib-base/resources/images/expandIcon.png" alt="Expand Icon"/> <img src="/content/patheon/us/en/insights-resources/blog/what-is-a-cdmo/_jcr_content/root/responsivegrid/well_copy_copy_copy/container/container/container_copy_65924/image_1297367049.coreimg.jpeg/1689266928545/what-is-a-cdmo-and-considerations-in-a-partner.jpeg" class="cmp-image__image popupEnabled " itemprop="contentUrl" data-cmp-hook-image="image" alt="Seven considerations for choosing a quality CDMO partner" data-mfp-src="/content/patheon/us/en/insights-resources/blog/what-is-a-cdmo/_jcr_content/root/responsivegrid/well_copy_copy_copy/container/container/container_copy_65924/image_1297367049.coreimg.jpeg/1689266928545/what-is-a-cdmo-and-considerations-in-a-partner.jpeg"/> </div> </div> </div> </div> <style type="text/css"> #container-1333437438{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1333437438 { border-radius: px; } </style> </div> <div class="cmp-well aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--8"> <div class="well " id="well-258528380"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> </div> </div> </div> <style type="text/css"> #well-258528380 { border-radius: 0px; } </style> </div> <div class="cmp-container aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--8"> <div class="cmp-container-inner " id="container-2028804215"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-e9518deb4e" class="cmp-text list-style-bullets"> <h3>Seven considerations when chosing a quality CDMO partner</h3> </div> </div> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-129b67db8c" class="cmp-text list-style-bullets"> <h5>Industry credibility<br /> </h5> <p>When evaluating a potential CDMO partner, it’s important to consider their industry reputation and overall credibility. A quality CDMO partner you can rely on will have a track record of success across all phases of drug development and manufacturing. Always ask to see case studies and success stories upfront so you can feel fully confident in the choice you’re making. Also, be sure to ask preliminary questions, such as “what project management system does your team utilize?”, “how many <a href="https://www.patheon.com/us/en/our-capabilities/small-molecule.html">small</a>- and <a href="https://www.patheon.com/us/en/our-capabilities/large-molecule.html">large-molecule</a> drugs have you worked with?”, and “which <a href="https://www.patheon.com/us/en/our-capabilities/advanced-therapies.html">therapeutic areas</a> do you specialize in?” By establishing the CDMO’s industry credibility upfront, you can avoid potential roadblocks later on.</p> <h5>End-to-end support</h5> <p>Many pharmaceutical and biotechnology companies want a one-stop shop that can handle a range of requests. A full-service CDMO needs to provide comprehensive, end-to-end <a href="https://www.patheon.com/us/en/our-capabilities.html">capabilities that support the entire pharmaceutical development and manufacturing process</a>. That includes drug substance and drug product development, <a href="https://www.patheon.com/us/en/our-capabilities/clinical-trial-services.html">clinical trial logistics</a>, product labeling, <a href="https://www.patheon.com/us/en/innovative-solutions/supply-chain.html">supply chain management</a>, <a href="https://www.patheon.com/us/en/our-capabilities/commercial-services.html">commercial packaging</a>, and more. By providing full-service support under one roof, the CDMO can reliably meet customer demands without them having to engage with multiple vendors. Being a true one-stop shop helps to streamline and simplify pharmaceutical development and manufacturing from beginning to end.</p> <h5>Proactive risk mitigation<br /> </h5> <p>According to the American Journal of Health-System Pharmacy, “as safety concerns about existing drugs continue and as more complex drugs and biologicals are introduced, the need to manage and mitigate risk while maintaining access to innovative therapies becomes increasingly important.” In fact, risk mitigation in drug development and manufacturing is vital to the pharmaceutical company’s overall success. Not only should a quality CDMO partner provide risk identification as the initial step, but they should also evaluate and prioritize risks as they evolve. Risk mitigation isn’t a one-and-done activity. Rather, it’s an iterative process that’s essential for bringing drugs to market — and it’s also essential to ensure patient safety.</p> </div> </div> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-072a5fde72" class="cmp-text list-style-bullets"> <h4><b><span style="color: rgb(255,65,54);">“Risk mitigation in pharmaceutical development and manufacturing is paramount to a drug program’s overall success.”</span></b></h4> </div> </div> </div> </div> <style type="text/css"> #container-2028804215{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-2028804215 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--8"> <div class="cmp-container-inner " id="container-263052277"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-f8929e1308" class="cmp-text list-style-bullets"> <h5>Overcommunication<br /> </h5> <p>Any relationship requires communication, and the relationship between a CDMO and a pharmaceutical company is no different. Communication — or really, overcommunication — is essential so both parties have a clear understanding of every project’s process. The pharmaceutical and biotechnology industry can change frequently when it comes to regulations, so it’s important to have a CDMO partner who stays on top of updates and can quickly switch plans accordingly. It’s also important to overcommunicate on project progress so everyone — including scientists, engineers, and partners — are on the same page. Transparency through overcommunication can help to resolve misunderstandings and overcome challenges, and it also allows for quick troubleshooting if anything goes awry.</p> <h5>Good project management</h5> <p>On the heels of overcommunication comes good project management — truly the heart and soul of any ideal CDMO partnership. A CDMO’s project management expertise can make or break a drug’s development and manufacturing journey, and a project will only be as successful as the project manager who’s behind the scenes, helping to make things happen. A good project manager should be able to anticipate problems before they happen to avoid costly delays, and they should always keep their partner in the loop with any plan changes. Project managers with solid communication skills who are quick and responsive to client needs are a key ingredient to a CDMO’s success.</p> <h5>Scalability<br /> </h5> <p>According to Deloitte, “as biotech companies attract fresh investment, they need to consider how they can scale up and what is required, in order to deliver on their promise of providing innovative medicines to patients.” It’s one thing to manufacture 100 pills; it’s another to manufacture 100,000 or even 1,000,000. A high-quality CDMO partner needs to have the flexibility to scale production to meet the clinical and commercial needs of pharmaceutical companies across all phases of their development journeys. When evaluating a prospective CDMO partner, make sure they have the right resources available to continually expand production as needed to avoid bottlenecks that can slow time to market.</p> </div> </div> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-617908ff33" class="cmp-text list-style-bullets"> <h4><b><span style="color: rgb(255,65,54);">“It’s one thing to manufacture 100 pills; it’s another to manufacture 100,000 or even 1,000,000.”</span></b></h4> </div> </div> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-51a12f2633" class="cmp-text list-style-bullets"> <h5>Trustworthiness<br /> </h5> <p>Working with a CDMO is a major financial investment — as with all partnerships, trust is key. You need to trust the overall competence of the CDMO you choose. After all, their quality of performance can make or break your drug’s journey from discovery to development and beyond. That said, trust can be difficult to quantify. What, exactly, makes a CDMO trustworthy? For one, they need to deliver on their promises to provide services and support to move your drug through the development journey. They also need to be transparent — especially in the face of any setbacks. Additionally, you need to trust that your intellectual property is safe in their hands, and that they share your vision of helping patients through pharmaceutical innovations.</p> </div> </div> </div> </div> <style type="text/css"> #container-263052277{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-263052277 { border-radius: px; } </style> </div> <div class="text aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--8"> <div id="text-e898806abb" class="cmp-text list-style-bullets"> <h3>Identifying the right CDMO company is a process</h3> </div> </div> <div class="text aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--8"> <div id="text-17f6a8c0aa" class="cmp-text list-style-bullets"> <p>On average, it takes 10-15 years and costs $2.6 billion to develop a new drug. That’s why it’s so essential that pharmaceutical companies partner with a CDMO they can trust, every step of the way. But identifying the right CDMO is a process — one that requires careful consideration. Although there are more than seven attributes to think about when selecting a CDMO company, trust — along with industry credibility, full-service support, proactive risk mitigation, overcommunication, good project management, and scalability — is an excellent place to start.</p> </div> </div> </div> </div> <style type="text/css"> #container-551763199{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-551763199 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--8"> <div class="cmp-container-inner " id="container-853727062"> <div class="aem-Grid aem-Grid--8 aem-Grid--default--8 "> </div> </div> <style type="text/css"> #container-853727062{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-853727062 { 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