CDMOs in the pharma industry rely heavily on state-of-the-art instrumentation to bring their client’s products from drug development through drug manufacturing to the patient. To better serve their client’s needs as technology and the industry advances, a CDMO must know when to acquire new and emerging technologies, increase their overall instrument capacity, and continually maintain their existing validated instrumentation.
For the previous blog in this series, raw material testing programs were outlined, and common considerations for Contract Development and Manufacturing Organizations (CDMO) were discussed. In this section, the focus will be a specific example and highlight some of the thought processes behind raw material program development. Captisol®, a common formulation excipient for injectables, will serve as said example.
Anyone with experience in the pharmaceutical industry knows that the APIs in drug products are tested rigorously for safety and efficacy before reaching the market. Before any raw material can be used for manufacturing, it must meet the requirements outlined in CFR chapter 211.84. Even minor issues with the API or a raw material could compromise the product’s integrity, leading to patient harm or expensive corrective actions such as recalls. Companies that perform drug product manufacturing and raw material testing take this responsibility seriously.
In the previous blog post, we addressed the challenge of successfully formulating such compounds for oral administration. However, once you have successfully encapsulated an API, the next task is to characterize that product and understand its release kinetics.
People who are not familiar with pharmaceutical development often express surprise and disappointment regarding the time and cost to bring new pharmaceuticals to market. Here are some interesting facts about stability testing: