Lyophilization ensures drug stability, delivers an extended shelf life, and enables long-term storage at room temperature. Because scale-up and technology transfer of the lyophilization process is challenging it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.
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.
The potential for antibody-drug conjugate (ADC) programs to accelerate from early-stage to late-stage clinical development highlights the need to establish commercial launch-ready manufacturing early and efficiently. Reduced time-to-market is key to deliver urgently needed therapeutics to patients, as well as to secure commercial success and maximize return on investment.
Due to its immense adaptability, extrusion has been widely utilized in diverse fields. Recently it is being adopted by the pharmaceutical industry at an unprecedented pace to address various drug product formulation and manufacturing needs. Learn more about this exciting yet complex technology and the many advantages it offers.
Customers choosing to partner with a trusted CDMO for drug development and manufacture can benefit from an established quality policy addressing management responsibilities, risk management, documentation, change management, CAPA, and process performance and product quality. Leveraging the expertise of a CDMO to assure product safety is a proven approach to product realization.