05.25.23 -- Strategies To Ensure Success: Getting It Right The First Time

An early-stage assessment tool can mitigate development risk and help minimize scale-up risk by facilitating the identification of potential issues — as well as informing the development of strategies to address them — before those issues become major problems. This process also is conducive to developing a more effective drug product.

The biopharmaceutical industry is trending toward building process characterization systems and processes early in a project’s life cycle, enabling success for later-stage development. In parallel, work must be done to prepare development and manufacturing for that later stage, whether to enable studies or to commercialize the product.

Not all CDMOs are suitably equipped to handle aseptic processing and sterile F/F operations on a clinical and a commercial scale. Samsung Biologics excels by offering robust safety measures and global reach, driven by continuous investment in initiatives that facilitate high product quality at greater speed and with more process flexibility.

Today, a plethora of CDMOs provide aseptic fill/finish services around the world. However, to offer customers favorable outcomes and exceptional value, a CDMO must make the curation and integration of deep market intelligence a core part of its service offering.