CROs, CMOs, & CDMOs IN THE PHARMA & BIOTECH INDUSTRY

03 Jul

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Contract Research Organisations (CROs), Contract Manufacturing Organisations (CMOs), and Contract Development and Manufacturing Organisations (CDMOs) are widely recognized terms in the realm of pharmaceutical drug discovery and development. However, these terms are becoming increasingly prevalent within the domain of construction, specifically in laboratory design and build companies.

Understanding the Drug Discovery Process:

Before delving into the roles of CROs, CMOs, and CDMOs, it's essential to grasp the drug discovery process. This process typically consists of two key phases: pre-clinical and clinical as shown below.

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The two stages can be further sub-divided as below

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The drug development journey can extend over a period of 10 to 15 years, incurring costs amounting to billions of dollars, before new drugs become accessible to patients. It's crucial to note that a multitude of researchers with diverse expertise, skills, and responsibilities collaborate at different stages of this process. Therefore, numerous pharmaceutical and biotechnology companies opt to outsource non-core services to reduce overheads, streamline their operations, and optimize costs. This outsourcing often involves contracting CROs and CDMOs.

Pharmaceutical companies choose to outsource pre-clinical and clinical research for a variety of reasons, including the therapeutic expertise offered by CROs, cost efficiencies, geographical advantages, and expediting the introduction of new drugs and treatments to patients.

Where do they fit in the Drug Discovery Process?

Pharmaceutical and biotechnology companies engage CROs throughout the entire drug discovery cycle, encompassing both pre-clinical and clinical stages. In my own scientific experience, I have worked in CROs that provided pre-clinical synthetic organic and medicinal chemistry services to pharmaceutical or biotech enterprises venturing into new therapeutic domains.

During the clinical stage, CROs are contracted to strategize, coordinate, execute, and oversee the clinical trial's entire lifecycle, ensuring its safety and efficiency. Serving as the primary liaison between the sponsor and other stakeholders involved in the trial, CROs interface with ethics and compliance committees, regulatory authorities, vendors, healthcare professionals, and research coordinators.

Notably, Bulb recently completed its inaugural project in the clinical trial facility design and delivery at the prestigious Canary Wharf in London. Our client is a rapidly growing specialist CRO and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. Keep an eye on www.bulblaboratories.com for case study details.

Distinguishing between CMO & CDMO organisations:

A CMO operates as only contract manufacturing organisation engaged by pharmaceutical firms to produce drug substances. Manufacturing services may encompass solutions, emulsions, nano-suspensions, liquid-filled capsules, aseptic filling, terminal sterilization, pre-filled syringes and vials, as well as tablets and capsules.

In contrast, a CDMO functions as a contract development and manufacturing organisation, assuming responsibility not only for the outsourced manufacturing of drug substances but also for all the innovation and developmental work preceding the manufacturing phase. This encompasses activities such as development, production, and analysis, relieving pharmaceutical companies of the necessity to construct and staff dedicated facilities for innovation and manufacturing. CDMOs provide a comprehensive suite of services, including formulation, analytical services, blending, coating, converting, packaging, and distribution.

The significance of CROs, CMOs, & CDMOs:

CROs, CMOs, and CDMOs transcend the role of mere outsourcing partners and hold a pivotal position in the journey of pharmaceutical, biotech, and medical device industries products to market. Their expertise, constant innovation, and adaptability make them active collaborators in the realm of scientific research, significantly contributing to their sponsor’ success.

Implications for the fit-out industry:

Fortunately, companies specializing in laboratory design and construction, such as Bulb, need not treat CROs, CMOs and CDMOs any differently from other Life Sciences clients since they engage in similar work. These organisations constitute an integral part of the existing science and technology ecosystem.

At Bulb, part of Unispace Life Sciences, we have collaborated with a multitude of entities, including those conducting in-house research like Engitix Therapeutics, OMass Therapeutics or Orchard Therapeutics as well as CROs & CDMOs like Quotient Sciences, Native Antigen among others.

Contact us today to know more about how we can assist your projects.Get in touch at or call 0118 988 9200.

Bulb Laboratories, part of Unispace Life Sciences, are the UK’s leading laboratory specialists providing design, consultancy, construction, and compliance services. With in-house expertise in science (end-user), laboratory design, engineering, and construction, we have unique credentials to cater to the complex needs of laboratory fit-out and refurbishment.

Our wide-ranging experience includes biotech, life sciences, medical devices, pharma, chemical, food & beverage, space, battery technology, and quantum computing companies ranging from university spin-offs to contract research and manufacturing organisations.

Dr. Manisha Kulkarni

Director of Science & Technology

07825 332406

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