A well-designed quality system has a global scope, incorporating guidelines from all relevant markets and assuring data quality and integrity through adherence to quality standards, policies, and procedures.
ASDs improve bioavailability to provide acceptable in vivo performance. However, ASD production requires an enabling technology. Spray drying and hot melt extrusion (HME) are among the most widely applied technologies.
Biologics are a growing, promising solution to address unmet medical needs. It is critical to have the right manufacturing partner to minimize challenges as a therapy moves from discovery to commercialization.
Aseptic fill/finish manufacturing is especially critical for highly valuable biologics drug substances, since with vast amounts of time and resources invested upstream, any errors resulting in loss of product at such a late stage can be catastrophic.
An effective strategy will reduce the probability of late-stage process, analytical, or manufacturing site changes that could put chemistry, manufacturing, and controls (CMC) activities on the critical path.
Positive outcomes are dependent on the patient’s experience with the therapies we create. How is patient-centricity influencing the therapy development process today, and how will the industry adapt for further patient-centric improvement?