CDMOs

Pharmaceutical development involves key activities that result in advancing a potentially new drug candidate into clinical practice. CDMOs usually offer these services in both preclinical and clinical stages.

Contract development and manufacturing organizations (a.k.a. CDMOs) are companies within the pharmaceutical industry that provide a variety of drug development and manufacturing services. Services provided by CDMOs may include development and or manufacturing services.

Analytical method development is the process of selecting an accurate assay procedure to determine the composition of a formulation. Analytical techniques are usually developed and validated for all components of a drug.

Pharmaceutical or drug manufacturing is the process of producing pharmaceutical drugs for clinical use. Contract manufacturing organizations (CMOs) are usually engaged during the process of drug manufacturing to make various drug components.

What is GMP? Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards set by regulatory authorities for the manufacturing of such medical product.

You will find many different letter combinations out there; CMO, CRO, CDMO and probably CRDMOs. What they all have in common is that they provide their services to other companies in the pharmaceutical industry on a contract basis.

A drug substance is any substance intended to provide pharmacological action finished pharmaceutical product while excipients are pharmacologically inactive substances that are generally used as a carrier of the API in the drug.

Pre-formulation studies are conducted to understand the physicochemical characteristics of compounds. Pre-formulation studies are important as they lay down the foundation for transforming a new drug entity into a pharmaceutical formulation.

Pharmaceutical formulation— is the process through which a variety of substances are combined with the drug’s active pharmaceutical ingredient (API) to produce a drug product. This video gives an overview of the factors considered and activities involved in formulation development.