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.

What is a CDMO exactly? Keep reading to learn more about CDMOs and how a successful partnership can carry a product from concept to commercialization.

cdmo lab technician

CDMO vs. CMO

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 development services in addition to the manufacturing services a CMO offers.

When pharmaceutical companies consider a CDMO versus a CMO, wide-ranging CDMO services, including 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.

3 Benefits of CDMOs 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.

1. End-to-End 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. 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 manufacturing facilities and invest in expensive equipment.

3. Ability to Scale

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 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.

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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?
  • 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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Meet a Unique 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. We have helped bring over 80 pharma products to market.

Our seven-acre pharmaceutical campus features our commercial manufacturing and packaging site, commercial warehouse and DEA-Approved vault. With extensive experience and a solid track record of bringing drug products to market, our capabilities are the best commercial pharma has to offer. Contact UPM to learn more about our contract development and manufacturing organization.

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