What services do CDMOs offer to pharmaceutical companies? 

Bringing a new pharmaceutical product to market is no easy feat. It requires tremendous resources, expertise, and dedication to ensure the product is safe, effective, and compliant with all relevant regulations. For companies that don’t have the in-house resources to manage this process on their own, working with a Contract Development and Manufacturing Organization (CDMO) can be essential. 

But what exactly do CDMOs offer to pharmaceutical companies? Let’s break it down. 

Preformulation testing 

CDMOs can help you characterize potential drug candidates by conducting testing for things like melting point, hygroscopicity, pKa, lipophilicity, crystallinity, solvent and pH solubility, excipient compatibility, particle size distribution, and more to assess the molecule’s physicochemical behavior and inform future product development. 

Analytical method development and validation 

A crucial early step in finished product development is developing, optimizing, and validating analytical methods suitable for testing the API, excipients, intermediate drug products, and finished product.  Depending on the dosage form, some such methods include cleaning verification, assay, related substances, dissolution, moisture, and microbial testing. 

Formulation development 

Once a drug candidate has been identified and characterized, CDMOs can develop the optimal formulation for the product, considering factors like the characteristics of the patient population, target dosage form, dosage strength, release profile, solubility, stability, bioavailability, and manufacturability. 

Clinical supply manufacturing 

CDMOs can produce the necessary quantities of cGMP drug product (and placebo) for clinical trials, ensuring that the product is manufactured according to current good manufacturing practices (cGMP) meets all necessary specifications and regulatory requirements. 

Packaging and labeling 

CDMOs can perform or manage the packaging and labeling of pharmaceutical products. This can include container-closure selection, testing, label design, storage, and distribution. 

Scale-up engineering 

Once a finished product formulation has been selected and clinical trials are underway, it’s time to scale the manufacturing process. Most pharmaceutical products go through at least one, and often up to three, scale-up engineering studies from small feasibility and early clinical scale of perhaps a few thousand dosage units to pilot scale (tens of thousands), then to registration scale (hundreds of thousands), and finally commercial scale (often around 1,000,000 units per batch). Depending on the scale of the necessary clinical trials, the expected commercial volumes, and the cost of API, these scale-up steps may be done early or late in the development process, and some may even be skipped entirely. 

Stability testing 

Stability testing is also an essential part of the development process. This involves testing the drug product under various conditions to ensure that it remains within its quality specifications over time. CDMOs use stability-indicating analytical methods to test the drug product and develop a deep understanding of its stability profile. In the early stages, this may be feasibility or accelerated stability testing used to help guide the optimization of the formulation or packaging. Later, concurrent clinical stability testing is needed to ensure that clinical supplies stay within specifications during the clinical trials. Finally, pivotal or registration stability at standard ICH conditions forms the stability data set needed in your filing to support your proposed expiration dating. 

Process performance qualification and commercial manufacturing 

Once a drug product is on track to be approved by regulatory agencies and is ready for commercialization, CDMOs can validate the commercial manufacturing process and provide the large-scale manufacturing capacity to produce the product at the necessary volumes and quality levels for the market. 

Supply chain management 

CDMOs can manage the entire supply chain for pharmaceutical products, from sourcing raw materials to transporting finished products to distribution centers and ultimately to patients. 

Regulatory support 

Throughout the development of a pharmaceutical finished product, CDMOs can provide guidance and support throughout the regulatory approval process. They can help ensure that all necessary documentation and data are in place to demonstrate the safety and efficacy of the product and even support the sponsor in preparing the filing documents and interacting with the healthcare authority via briefing documents, questions, and teleconferences or meetings. 

Overall, working with a CDMO can provide pharmaceutical companies with a comprehensive suite of services to help bring their products to market more quickly, efficiently, and cost-effectively. CDMOs offer a wide range of services to pharmaceutical companies, from pre-formulation and formulation development to analytical development and validation, clinical supply manufacture and packaging, stability testing, and commercial manufacture and packaging of prescription pharmaceutical finished products.  

By partnering with a CDMO with the expertise and resources to manage every aspect of the development and manufacturing process, you can focus on your core competencies and ultimately achieve greater success in the highly competitive pharmaceutical industry.