Pharmaceutical companies face a myriad of challenges during the long and complex processes involved in developing and manufacturing new drug substances. A partnership with the right contract development and manufacturing organization (CDMO) can help bring new pharmaceutical products to market by providing expertise and scalability and reducing costs.
But what is a CDMO exactly? Keep reading to learn more about what roles CDMOs play in pharma development and how a successful partnership can carry a pharmaceutical product from concept to commercialization.
- CMO vs CDMO
- 3 Benefits of CDMO Services In Pharma Development & Manufacturing
- Questions & Considerations When Choosing a CDMO Partner
- Partner with a Qualified CDMO: UPM Pharmaceuticals
CMO vs CDMO
Pharmaceutical companies outsource drug manufacturing to CDMOs (contract development and manufacturing organizations) or CMOs (contract manufacturing organizations) because they need access to capacity or technological capabilities beyond what they have in-house and mitigate risk by outsourcing to a secondary supplier.
A contract manufacturing company provides an option to pharma companies with drug formulas that are ready to go, whereas full-service CDMOs provide pharma development services in addition to the manufacturing services a CMO offers.
When pharmaceutical companies consider a CMO vs a CDMO, wide-ranging CDMO services, including commercial drug manufacturing, research and development, analysis, clinical trials, and post-marketing product support, offer more flexibility, consistency, and expertise, making CDMOs the preferred choice even for pre-formulated drugs. Advancing from a CMO to a CDMO provides greater opportunities for innovation and specialization.
Challenges CDMOs Will Help Pharmaceutical Companies Solve
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Economies of Scale: CDMOs often have large-scale manufacturing facilities, allowing pharmaceutical companies to benefit from economies of scale and cost-effective production.
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Speed of Development: CDMOs can expedite the drug development process by providing ready access to manufacturing capabilities, reducing time spent on facility setup and validation.
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Quality and Regulatory Support: CDMOs are often well-versed in regulatory requirements and can help ensure that pharmaceutical products meet the necessary quality and compliance standards.
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Risk Sharing: Collaborating with CDMOs allows pharmaceutical companies to share risks associated with drug development and manufacturing, as CDMOs often have more diversified portfolios and experiences with various projects.
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Outsourcing Non-Core Activities: Pharmaceutical companies can focus on their core competencies, such as research and marketing, while outsourcing manufacturing and development to specialized CDMOs.
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Capacity Constraints: Pharmaceutical companies often face limitations in their internal production capacities, hindering their ability to manufacture products on a large scale. CDMOs can provide the necessary production capacity to meet market demand.
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Compliance Management: CDMOs can assist in managing the costs associated with compliance by spreading them across multiple clients, making it more affordable for individual pharmaceutical companies.
3 Benefits of CDMO Services In Pharma Development & Manufacturing
Among the many pressures that pharmaceutical companies face is the need to invest in equipment, technology, and expertise, meeting the demands of global supply chains and reducing costs without compromising product quality and patient safety. Partnering with top CDMOs provides the following benefits to your company:
1. End-to-End Pharmaceutical Expertise
CDMOs offer access to additional expertise by offering researchers who have the needed experience and specialized skills at each stage of drug development and manufacturing without increasing payroll costs.
2. Provided Equipment & Facilities
A wide range of equipment is required for manufacturing various drug forms, and the costs are high. Partnering with a CDMO reduces or eliminates the need to build and staff pharmaceutical manufacturing facilities and invest in expensive equipment.
3. Ability to Scale Drug Projects
Adding a new drug variation or shifting production volume to meet increased demand can put a project at risk through failure to meet production deadlines or maintain quality and homogeneity. Using a CDMO for scale-up support reduces the risk and shortens lead times.
Full-service CMDOs allow pharmaceutical companies to stay nimble and lean while receiving extensive, differentiated drug development and support. Such specialized CDMO services ensure greater flexibility and manageable cash flow than would be achievable internally. Furthermore, outsourcing frees up time and resources to focus on drug discovery and marketing, pushing the pharma industry forward.
Challenges CDMOs Will Help Pharmaceutical Companies Solve
-
Economies of Scale: CDMOs often have large-scale manufacturing facilities, allowing pharmaceutical companies to benefit from economies of scale and cost-effective production.
-
Speed of Development: CDMOs expedite the drug development process by providing access to readily available manufacturing capabilities, which reduces time spent on facility setup and validation.
-
Quality and Regulatory Support: CDMOs are well-versed in regulatory requirements and help ensure that pharmaceutical products meet the necessary quality and compliance standards for safety, purity, and efficacy.
-
Risk Sharing: Collaborating with CDMOs allows pharmaceutical companies to share risks associated with drug development and manufacturing, as CDMOs often have more diversified portfolios and experience with various projects across different indications, phases, and routes of administration.
-
Capacity Constraints: Pharmaceutical companies often face limitations in their internal production capacities, hindering their ability to manufacture products on a large scale. CDMOs can provide the necessary production capacity to meet market demand.
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Compliance Management: CDMOs can assist in managing the costs associated with compliance by spreading them across multiple clients, making it more affordable for individual pharmaceutical companies.
Questions & Considerations When Choosing a CDMO Partner
Choosing the right CDMO partner is critical for a drug project's success. According to CDMO outsourcing market research, technological capability and specialized technologies have replaced reduced costs as the top priority when forming a CDMO partnership. A CDMO's location, supply chain compatibility and GMP compliance are also driving factors.
Other questions to ask about a potential CDMO partner include:
- How long have they been providing CDMO services?
- Are they a contract manufacturing company with commercial manufacturing services to cover the drug delivery system for your drug substance?
- Do they provide specialized handling capabilities—such as semi-solid, solid dose, high-potent, controlled substance, and sustained-release tablet handling?
- When looking at a CDMO's facility and equipment, do they have the space and equipment to handle the production levels you need to reach your goals? Top CDMOs are not judged strictly on scale but also on flexibility.
- Have you found a CDMO that is large-scale as well as agile to meet your unique specifications?
Finally, consider the willingness of a CDMO, meaning how do they approach working together through the inevitable challenges of getting a pharma product commercialized? Are they willing to listen and involve you in the process?
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Partner with a Qualified CDMO: UPM Pharmaceuticals
Bringing a new drug to market is a lengthy, costly, and risky journey, compounded with the time pressure of being first in the marketplace. UPM is unlike other CDMOs because we are a large pharma supplier and an independent, family-owned CDMO, allowing us greater flexibility in our partnerships. To this point, our ended-to-end CDMO services have helped bring over 80 pharma products to market.
Our state-of-the-art seven-acre pharmaceutical campus features our commercial manufacturing and packaging site, commercial warehouse, and DEA-Approved vault. With extensive pharmaceutical industry experience and a solid track record of bringing drug products to market, our capabilities are the best that commercial pharma has to offer. Contact UPM to learn more about our contract development and manufacturing organization and how we can optimize your pharmaceutical project results.
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