Contract manufacturing organizations (CMOs) and contract research organizations (CROs) are integral to the pharmaceutical industry. Before discussing the difference between CMOs and CROs, it is important to understand the drug lifecycle and how medical innovations move from discovery to patient access.
There are three main phases of the drug lifecycle: discovery, development, and delivery.
The discovery phase includes identifying the drug candidate and performing preclinical research to assess if it is a suitable therapeutic. The development phase encompasses clinical research from phase I through phase III clinical trials and optimizing manufacturing and formulations processes. The delivery phase includes commercialization and clinical phase IV trials, which usually involves scaling up manufacturing. Each phase of the drug lifecycle requires significant resources, technical and regulatory expertise, facilities/capabilities, and time. Partnering with a CRO and/or CMO allows pharmaceutical companies to gain access to capabilities and expertise that are complementary to in-house skills, which can accelerate time to market, de-risk projects, and substantially cut costs.
Define Contract Research Organization
A CRO is a company that supports the pharmaceutical, biotechnology, and medical device industries by conducting research ranging from high throughput testing to identify drug candidates (i.e. initial discovery) through phase IV clinical trials. CROs can vary by indication, capabilities (preclinical vs. clinical phases), and technology offerings.
Define Contract Manufacturing Organization
Pharmaceutical contract manufacturing organizations (CMOs) can be contracted by pharmaceutical, biopharmaceutical, and biotechnology companies to manufacture the necessary amount of a specific product for preclinical research, clinical trials and commercialization. CMOs vary in capabilities, size, and expertise, some even offer a “one-stop-shop” model, reducing the number of vendors pharmaceutical companies need for one specific product or pipeline.
Several outsourcing companies are being marketed as CDMOs, contract development and manufacturing organizations, which are able to offer services to support discovery, development, and delivery phases of the drug lifecycle. Similar to CROs and traditional CMOs, offerings vary between CDMOs, but the expanded service model fosters long-term relationships that can reduce delays associated with technology transfer and increase speed to market.
Services offered by Contract Manufacturing Organization vs. Contract Research Organizations
Each CRO differs in their service offerings and strive to differentiate themselves from the competition by offering unique services, support, and/or technologies. CROs offer study design and management by leveraging their expertise in a specific indication/field and regulatory knowledge. Generating streamlined, cost-effective research for novel substances involves developing a custom method, optimizing and validating existing methods, and identifying and mitigating liabilities in preclinical studies through clinical trials.
Many pharmaceutical CROs offer clinical trial services; some offer services for all phases (I-IV), whereas others may offer services specific to the development phase of the drug lifecycle (phases I-III). In early phase development, CROs can support pilot studies to identify ideal dosage regimens and safety and efficacy characteristics. Phases I–IIa are critical for determining the direction of future studies, generating regulatory compliance, and satisfying stakeholders. Partnering with CROs on phase IIB-III clinical trials can help avoid pitfalls, such as lacking a clearly defined clinically useful dose range or patient characteristics predictive of response, that increases the likelihood of failure and massive costs. Outsourcing the design of phase IIIB-phaseIV clinical trials to evaluate the efficacy and safety to file for a marketing authorization or explore new indications, comparators, efficacy endpoints, and new methods to assess efficacy can free up time and resources for pharmaceutical companies. They can prioritize other initiatives such as other pipeline drugs, marketing, etc. while the CRO strategizes lengthy trials aiming to evaluate the product’s potential success in a clinical setting and the market.
Forward-thinking CROs offer unique services, expertise, and technologies that pharmaceutical companies can leverage to generate higher quality data, streamline project management, and determine next steps faster. Real world evidence describing the clinical, economic, and humanistic value of innovative drugs and technology for real-time access to data are some unique services offered.
Examples of Contract Research Organizations
Worldwide Clinical Trials
Worldwide Clinical Trials is a full-service CRO with a global presence and an extremely deep level of medical expertise that offers support for any stage clinical trial in numerous indications.
Biorasi is an innovative CRO offering technology- and data-driven clinical research support and trial rescue solutions for wide-ranging therapeutic areas.
Pharmaceutical Product Development (PPD)
Pharmaceutical Product Development (PPD) is a globally renowned CRO operating in 48 countries and is recognized as a top supplier based on their capability, compatibility and expertise in assisting clinical research programmes.
Historically, CMOs specifically offered drug manufacturing services and relevant analytical support. Modern CMOs are offering more comprehensive solutions to support companies from discovery through commercialization and delivery. Many CMOs offer research and development services in the form of protocol establishment and optimization (i.e. cell line development), material production for preclinical research and clinical trials and regulatory support throughout each phase. Regulatory support is now an expectation of CMOs to help pharmaceutical companies navigate frequently evolving guidelines and ensure compliance. Drug substance production is the primary service of CMOs. Once a drug is deemed a suitable therapeutic via preclinical and early stage clinical trials, CMOs establish a commercial manufacturing process to consistently produce the target drug substance of the intended quality. An optimized manufacturing process is critical to getting life saving drugs to patients as quickly as possible by mitigating costly delays and bottlenecks. Drug substance production activities can include characterization, solid state research, process development, analytical development, quality control, stability studies, and manufacturing to, ultimately, determine the best possible synthesis or production route for the drug.
Manufacturing the required quantity is only one piece of the puzzle when it comes to finalizing a drug. Formulations can affect efficacy, stability, and quality and can determine patentability, lifecycle, and the success of a pharmaceutical product. Many CMOs offer formulated drug production services, which is a process that involves dosage form development, dosage form production, packaging, and logistics to produce the final medicinal product.
From discovery through commercialization, CMOs often offer a full suite of analytical services to deliver high quality products and comply with regulatory guidelines. These services can be wide-ranging depending on the specific project, but can include methods development and validation, stability studies, raw materials and trace metals assessment, and microbiology/contamination evaluation.
Examples of Contract manufacturing organizations
Catalent is a world renowned CMO that has a vast array of expertise in oral dosage, biologics, clinical supply and consumer products (nutritional supplements, beauty, etc.). It offers development and manufacturing services for clinical and commercial applications.
Samsung Biologics is a one-stop shop contract development and manufacturing organization with wide-ranging capabilities supporting biopharmaceutical companies from research and development through commercialization. Additionally, Samsung Biologics offers contract research services for biosafety and analytical testing.
Lonza is a CMO that offers clinical development, clinical and commercialization manufacturing for biologics and small molecules. In addition to specializing in pharma and biotech, they have expertise in capsules and health ingredients, microbial control, and specialty chemical services.