Reach your drug manufacturing goals by working with CDMOs (contract development and manufacturing organisations). In this blog, we explore exactly what CDMOs are and how they can help your business to overcome challenges in the long and complex process of developing new drug substances.

What is a CDMO?

CDMO stands for contract development and manufacturing organisations. They enable pharmaceutical companies to outsource drug manufacturing, allowing them to bring solutions to market faster whilst keeping expenses in check. Having a CDMO partner gives you instant access to expertise and equipment, without having to perform it in-house, saving money and helping you to achieve your goals much faster. CDMOs can carry out drug formulation, process development, scale-up, clinical trials and commercial manufacturing. CDMOs are often hired by pharmaceutical and biotech companies that do not have the necessary resources or expertise to perform these tasks in-house.

What services do CDMOs offer?

CDMOs offer a wide variety of services, including drug development, process optimisation, analytical testing, formulation development, clinical trial material manufacturing and commercial manufacturing. CDMOs can provide support at any stage of the drug development process, from early-stage development to late-stage development and commercial manufacturing. Some CDMOs specialise in certain areas, such as small molecule development, biologics development, or sterile injectables. CDMOs can also offer specialised services, such as gene therapy manufacturing. Overall, CDMOs offer a comprehensive range of services to help pharmaceutical and biotech companies bring their products to market quickly and efficiently.

What’s the differences between a CMO, CDMO and a trailblazing CDMO?

A CMO (contract manufacturing organisation) focuses purely on manufacturing. They don’t get involved in any of the early development work. So if a company already has a drug developed and ready to go but doesn’t have the facilities to produce it in large volumes, a CMO can step in to handle that side of things.

A CDMO (contract development and manufacturing organisation) goes further. They help with both the development of the drug’s active pharmaceutical ingredient (API) and the manufacturing. This can save pharmaceutical companies a lot of time and investment, as they don’t need to build their own in-house teams or infrastructure.

A CRO (contract research organisation) supports the earlier stages of the drug development process. They run clinical trials, manage regulatory submissions, and carry out research needed to move a drug through approval. CROs are especially valuable when a company wants to navigate the complex clinical and regulatory landscape more efficiently.

Trailblazing CDMOs offer something extra. They bring in next-generation technologies and push innovation to solve tough manufacturing problems. That might mean more efficient production methods, new ways of making APIs, or more flexible solutions for complex molecules.

In the end, choosing between a CMO, CDMO or CRO depends on what a company already has in place. For those lacking internal capacity, working with a CDMO or CRO can provide the expertise and technology needed to move a drug from idea to launch, all with fewer hurdles.

How can pharmaceutical companies benefit from CDMOs?

CDMOs hold plenty of benefits for pharmaceutical companies:

• End-to-end support – CDMOs provide expertise throughout the entire development and manufacturing process, applying specialised skills and knowledge to each stage of the project.
• Improved equipment and facilities – a huge amount of facilities are required to develop a drug and this specialised equipment isn’t cheap. CDMOs provide state-of-the-art facilities and staff.
• Ability to scale – by working with CDMOs, pharmaceutical companies can think big and quickly scale their drug production.
• Reduce costs – by having all of the staff, equipment, infrastructure and knowledge provided, companies only have to pay the contract fee, saving money. 
• Meet deadlines and boost efficiency – CDMOs stay agile and are able to quickly shift to meet tight deadlines and increased production.

What challenges can CDMOs help pharmaceutical companies to solve?

CDMOs can help pharmaceutical companies overcome several challenges, particularly in drug development and manufacturing. They offer expertise in scaling production, ensuring consistent quality, and meeting regulatory standards. CDMOs also provide access to advanced technologies and innovation, which can improve efficiency and reduce costs. By outsourcing development and manufacturing, pharmaceutical companies can focus on their core strengths, shorten time-to-market, and mitigate the risks of building expensive in-house facilities, all while maintaining a high level of product quality.

​What should you consider when choosing a CDMO?

Choosing the right CDMO partner to work with is an important decision and can hugely influence the success of your drug development. It’s vital to consider the expertise you require, facilities and budget. Here are some key questions to ask yourself:

• In which stage of development are you?
• Are you working with an API that requires specialised expertise?
• Do they offer the flexibility and collaboration required?
• How long have they been providing their services?
• Do they have the knowledge and resources to meet your production needs?

Aligned with your organisation

A CDMO that’s aligned with your organisation can increase the success of your drug, developing and manufacturing it to new heights. It’s vital to get the right partnership, which is why we take the time to get to know our clients first to see if we are the right fit for their projects.

Contact us today to discuss your Tides goals and requirements.