What is a CDMO & Why Might You Need One?

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.

Innovation Oligonucleotide Manufacturing

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

A CMO (contract manufacturing organisation) manufactures drugs for pharmaceutical companies but doesn’t carry out any of the development required beforehand. A company may wish to work with a CMO if they already have a drug ready to go but don’t have the manufacturing resources to mass produce. 

A CDMO (contract development and manufacturing organisation) carries out development of a drug API before manufacturing it. This allows pharmaceutical companies to save money, time and resources as they no longer have to build and staff dedicated development and manufacturing facilities.

The trailblazing CDMOs go a step further than a CDMO. They offer next-generation technologies and focus highly on innovations that address manufacturing challenges. This opens new ways in which APIs can be made as ingredients for medicines.

Therefore, whether a company chooses to work with a CDMO or CMO largely depends on its resources in-house. By working with a CDMO, pharmaceutical companies gain access to knowledge, innovation and collaboration with an expert team, helping them to successfully develop and manufacture their drug.

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.
  • 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 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. 

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