11.25.20 -- The Value That Experience Brings To HPAPI Manufacturing

Aseptic fill/finish manufacturing is one of the final, but crucial, steps between biopharmaceutical development and patient care. This process is especially critical for highly valuable biologic drug substances, since any errors resulting in loss of product at such a late stage have the potential to be catastrophic. One way to mitigate the risk associated with aseptic fill/finish manufacturing is to partner with a contract manufacturing organization (CMO).

Pharmaceutical companies regularly turn to contract manufacturing organizations (CMOs) to help progress drugs from development through to commercialization. An embedded CMO offers many advantages over other CMO models, not least is access to the extensive capabilities and know-how of the parent organization.

Establishing a platform approach to process characterization ensures the entire process is robust, right the first time, and results in a highly consistent product to facilitate efficient BLA filing. This five-step process provides a thorough understanding of the biologic and process control strategies that accelerate time to a robust and reliable commercial-scale process.

As the demand in the global market for highly potent active pharmaceutical ingredient (HPAPI) drugs grows, so too grows the expense of manufacturing HPAPIs due to the requirements for specialized facilities, additional PPE, medical surveillance for workers, pollution controls, and specialized housekeeping. As a result, more and more often the question pharmaceutical companies find themselves asking is, "Should we be searching for a CMO to manufacture our HPAPI?"

Having standards in place for engineering controls is the first line of defense against harm from cross contamination or exposure to the patient, manufacturing employees, or the environment when working with HPAPIs. In this article, learn how to determine exposure potential and select the correct equipment and technology.

The limited solubility of many modern drugs frequently translates to low bioavailability, making improved solubility a primary goal of oral dosage formulation development. Low aqueous solubility can be combated through preparation of an amorphous solid dispersion (ASD). This article explores spray drying and hot melt extrusion (HME), which are among the most widely applied technologies for producing ASDs.