An active pharmaceutical ingredient (API) is any substance or a mixture of substances used in a finished pharmaceutical drug product to provide pharmacological action. Custom API development refers to the production of desired quantities of APIs exclusively on a specified scale as per the customer's requirement.
Drug substance development and manufacturing is the foundation on which pharmaceutical products are built. A company can use either a traditional approach or an enhanced approach to drug substance development, or a combination of both. The amounts produced during the synthesis of APIs tend to be small, ranging from a few milligrams to about 10 kilograms, and this can be carried out in-house or by manufacturers.
Custom development is essential to the pharmaceutical industry as many active pharmaceutical ingredients (APIs) are sometimes very difficult to find or are hard to synthesize. Custom synthesis provides a platform to the clients to accelerate time to market for finished dosage forms (FDF).
The requirements for complex chemicals to facilitate new innovations in drug development pose challenges for all drug development firms. The need for custom drug substance development and manufacturing in the pharmaceutical and biotechnology industries continues to expand.
There are many active pharmaceutical ingredients (APIs), such as small molecule APIs, high potency APIs, small molecules, cytotoxic compounds, biological drug substances and large molecules such as peptides that require complex procedures for their synthesis. Companies prefer to outsource them to contract development and manufacturing organizations and contract manufacturing organizations.
These pharmaceutical companies offer drug substance development services and custom API development and manufacturing along with pharmaceutical drug products. Custom drug substance development companies offer various services, including process and analytical validation, quality control and quality assurance, kilo scale, pilot scale and commercial production. Fully integrated contract development & manufacturing organizations offer drug substance manufacturing and enable the outsourcing of a broad variety of contract development activities from cytotoxic compounds, peptides, biological substance, small molecule drug substance manufacturing to the full scale clinical and commercial manufacturing.