What is a CDMO? A guide for Business
Keywords: CDMO, Pharmaceutical CDMO.
In 2020, nations turned to pharmaceutical companies to create a vaccine for COVID-19. As it turned out, these companies delivered the product in less than a year. Governments suspended many regulations and processes to ensure these developers could create a vaccine quickly. However, the story of the COVID-19 vaccine is an atypical one. Most of the time, pharmaceutical companies struggle to navigate the development of a new drug and the regulations surrounding them. These challenges only increase as drugs become more complex. That’s why pharma companies often work with CDMOs to speed up their drug development. If you’re unfamiliar with what a CDMO does, keep reading, we’ll answer all your questions in this article.
What Is a CDMO?
CDMO stands for Contract Development and Manufacturing Organization. The goal of these specialized organizations is to bring expertise and accelerate how pharma companies bring new drugs and therapies to the market. Working with a CDMO provides several benefits. Indeed, these groups understand how to lower the risks associated with the lengthy, expensive drug development process. Another important point, is that they can also save your business money: think about how much your company invests in expanding its infrastructure. The average ‘research and development to marketplace’ cost for new drugs come to nearly $4 billion. Sometimes, this figure can exceed $10 billion. Many companies spend significant portions of this money on manufacturing. Likewise, they often extend their manufacturing capacities. To make matters worse, you may spend all of this money and still not receive FDA clearance for the drug. In other words, the development process brings significant financial risk to your company. A pharmaceutical CDMO can help you avoid these expenses and risks. They do all or part of the work associated with developing and manufacturing your new drug. This includes purchasing and qualifying equipment and providing the necessary infrastructure. In doing so, they spare your company the expenses associated with research and development.
What Is the Difference Between a CDMO and a CMO?
Many people mistake CDMOs for CMOs. However, there are significant differences between the two.
First, CMOs stand for Contract Manufacturing Organization . As their name suggests, these companies are specialized in manufacturing using a defined manufacturing process. For example, they can manufacture medicines, that may include some of the following:
- Solutions
- Emulsions
- Nano-suspensions
- Liquid-filled capsules
- Pre-filled syringes and vials
Many drug companies rely on these partners to handle these tasks and save them money. It’s much more cost-effective to outsource your manufacturing needs than to pay for them out of pocket. On the surface, these responsibilities may seem identical to those provided by CDMOs. However, a careful observer will note that CDMOs include an extra letter in their names.
That’s because CDMOs don’t just handle manufacturing. They also provide development services for drug companies. As such, they provide all of the innovative and developmental work that goes into manufacturing drugs. This work includes:
- Development
- Production
- Analysis
- Laboratory testing
- New technologies
By providing these services, CDMOs prevent companies from spending unnecessary money on their infrastructure. Instead, pharmaceutical companies can rely on them to handle these lengthy and expensive tasks.
How To Work With a CDMO
You may wonder how to start your work with a CDMO. First, determine what you need and want from these organizations: What kind of drugs do you need them to develop? What is the goal of this process? From there, you can search for CDMOs that have a background in these fields. For example, you may want one of these organizations to help you develop viral vector drugs. So, find a company with a robust background in this industry. Once you find the right CDMO, you’ll enter into a contract with them. Ensure your contract seems fair, both to your company and theirs. Then, keep the lines of communication open. Check-in with this organization throughout the research and development process. Ensure they understand your goals and provide them with any further information they need.
How To Choose The Best CDMO
Working with a CDMO starts with finding the best fit for your company. However, you may not know how to find the right fit. There are several qualities to look for when you search for a CDMO. First, look for the range of services the company provides: do they offer the right capabilities to cover all your needs? Next, look for their track record in development and clinical manufacturing: have they had any issues or public stories about bad products? Have they had recalls or other problems associated with their products? It also helps to find a company that has the flexibility necessary to accommodate your approach: can they process your company’s unique requirements? Next, ensure they have the equipment and facilities your company requires. It also helps to know if they have a scalable operation: as your company grows, can this organization continue to provide research, development, and manufacturing services? Every CDMO should also provide a comprehensive regulatory history and experience with their regulatory submissions. So, make sure your potential CDMO can provide the information you need for filing. They should also offer support in filling out any sections of regulatory documents that you’re unclear about. Finally, consider the organization’s willingness to support you throughout your project. How will they prioritize your company’s work against existing orders and larger clients’ needs? Understanding your position in the hierarchy can go a long way when deciding on a CDMO.
Consider Working With Us
Working with a CDMO can produce several benefits for your company. It can mitigate financial risks, save money, and accelerate your production. However, first, you need the best CDMO.
To that end, consider working with us! We are one of Europe’s largest CDMOs for cell and gene therapy viral vector manufacturing. We offer a full range of services in lentiviral vectors and AAV (Adeno-Associated Virus) cGMP manufacturing.
In top of that, flexibility and transparency are some of our pillars. We will adapt to your project and you will always know where your project stands.