What is a CDMO?
Contract development and manufacturing organization (CDMO) is a pharmaceutical company that provides drug development and manufacturing services. Pharmaceutical companies collaborate with CDMOs to outsource drug development and manufacturing.
Full-service CDMOs can handle all aspects of drug development and manufacturing and work with clients who want to outsource specific parts of their process. It all depends on what the client requires.
Some of the services offered by CDMOs include:
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- Analytical Services
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A pharmaceutical company can begin with little more than a concept and be guided through pre-formulation and formulation development, clinical trials, and commercial production when partnering with a full-service CDMO.
What’s the Difference Between CDMO and CMO?
The distinction between a contract development and manufacturing organization (CDMO) and a contract manufacturing organization (CMO) is in development. CMOs are companies that take a pre-formulated drug and manufacture it, whereas CDMO businesses do both drug development and manufacturing.
Many pharmaceutical companies prefer working with a CDMO over a CMO because of its consistency and timeliness. In the end, a CDMO partnership schlafmaske seide provides fewer opportunities for finger pointing.
Pharmaceutical companies increasingly turn to CDMOs to handle drug development and manufacturing complexities. Whether navigating the FDA’s highly regulated drug development framework or scaling production to meet deadlines and demand, having a CDMO partner can be a great resource with many benefits for pharmaceutical companies looking to focus their efforts and resources on initiatives that will move their company forward.
Advantages and Costs of Contract Manufacturing
A new drug or variation takes millions of dollars to develop. Pharmaceutical companies benefit greatly from collaborating with a CDMO to develop and manufacture a new drug.
Advantages of Contract Manufacturing
We dedicate our expertise, as well as our equipment and facilities, to each client partnership to accelerate the process of bringing a drug to market.
A full-service CDMO has an incredible depth and breadth of experience and specialization. CDMOs should invest in talented researchers, chemists, and development professionals because this is their core competency. After all, those who can provide pharmaceutical companies with insight, oversight, and innovation will be the most successful.
Equipment and Facilities
Leading CDMOs are also making investments in equipment. Pharmaceutical companies face a difficult decision regarding internal drug development and manufacturing when they want to increase capabilities, introduce a new drug, or manufacture at a different rate. After all, those decisions all require large capital investments.
Outsourcing to a biologics CDMO, on the other hand, provides companies with access to large amounts of equipment and facilities without incurring the expense of ownership.
CDMO providers are well-known for their ability to assist pharmaceutical companies in scaling. Changes in production volume or introducing a new drug variant can be extremely risky for pharmaceutical companies. However, when collaborating with a CDMO, those decisions are much lower risk and have shorter lead times.
Pharmaceutical development and manufacturing outsourcing allow businesses of all sizes to scale. Large and small pharmaceutical companies can run leaner and more efficiently, knowing that their drug development and manufacturing costs will not break the bank.
What to Consider When Choosing A CDMO Partner?
When selecting a CDMO partner, the first thing to consider is whether they have the technical expertise and experience to deliver on your goals. Do they have prior experience with the drug delivery systems you’re interested in? Is their staff technically savvy enough to accomplish what you want?
Look at their equipment and facilities next. What are their plans for laboratory space and equipment? What about mixing, coating, and converting machines? Do they have the capacity to handle the output levels you require?
Finally, consider how the CDMO approaches partnerships and relationships. Are they attentive listeners? Do they make you feel like you’re a part of the process? Are they the company that will stick with you when things get tough? These are all questions to think about when selecting a CDMO partner.
Develop A New Drug
The development of new drugs is a highly regulated and time-consuming process. All drugs introduced to the market in the United States over the last 30 years must go through the FDA drug development process. Due to their complexity, many pharmaceutical companies rely on CDMOs for drug development services.
What is a Drug Development Cycle?
The U.S. drug development process, as outlined by the FDA, includes five steps:
- Discovery and Development
- Preclinical Research
- Clinical Research
- FDA Review
- FDA Post-Market Safety Monitoring
Discovery and Development
While the idea for a new drug may emerge over lunch or during a boardroom discussion, every drug’s discovery begins in the laboratory. Research and development is a critical component of drug development that serves as the foundation for all subsequent steps.
Discovery and development can create new chemical or organic compounds, new insights into an existing disease, and even new technologies for delivering an existing drug.
Preclinical research is done to determine a compound’s toxicity, which is accomplished through in vitro and in vivo testing. Scientists experiment with dosage and work to establish safety metrics during this time.
Clinical research investigates how a drug interacts with the human body. It is common practice in clinical research to conduct drug trials on humans and animals. The FDA establishes specific human testing criteria that apply to all stages of clinical research.
FDA Drug Review
The FDA drug review process is the next step in drug development. When a company’s research and trials show that its drug is safe and effective for its intended use, it can apply to the FDA for review and approval. The company gains the right to market the drug is approved.
FDA Post-Market Safety Monitoring
Post-market safety monitoring ensures that drugs remain safe and effective in the market. The FDA inspects drug manufacturing facilities regularly to look for problems with prescription or over-the-counter drugs and evaluate and approve changes in dosage or usage information.
CDMO PARTNERSHIP AND DRUG DEVELOPMENT
CDMO industry works alongside pharmaceutical companies at every stage of drug development, assisting them in navigating the process and mitigating risk.
All drugs approved in the United States over the last 30 years, whether over-the-counter or prescription, underwent a lengthy, multi-year, multi-million dollar process before being made available to patients. It is a major undertaking fraught with risk, oversight, and regulation.
To bring a new drug to market, extensive resources, technical expertise, and an unwavering commitment to the goal of approval are required. By forming the right partnerships, you can give your drug development program the competitive advantage required to reach the market.