The biopharmaceutical industry exists to develop novel therapeutics that address unmet medical needs. The evolving research and development landscape for these complex therapeutics has made streamlining their scaling and commercialization an increasingly crucial consideration. For many biotechs, this means finding a sustainable contract manufacturing and development organization (CDMO) capable of executing seamless tech transfer and guiding a therapeutic asset to market acceptance and beyond. The increasing demand for expedited timelines for the CMC (chemistry, manufacturing and control) program and drug approval process should be supported by facility capacity, flexibility as well as technical capability for seamless tech transfer in CDMO. Through effective technology transfer mechanisms, stakeholders can accelerate the translation of scientific breakthroughs into lifesaving treatments.

Quality by Design (QbD) is a strategic approach that intends to ensure the high quality of drugs by employing statistical and risk-management methodology in the design, development and manufacturing of drugs. Over the years, QbD's focus has been on the process design, understanding, as well as process control, as discussed in the ICH guidance. The core principle of QbD is to identify and comprehend the relationships between the product's CQAs (Critical Quality Attribute) and the CPPs (Critical Process Parameter) that influence them. This process understanding is obtained through a combination of holistic risk assessment, design of experiments (DoE), and statistical analysis though the study called Process Characterization (PC). Understanding of criticality and ranges of process parameters along with defining process design space is essential for establishing a robust Process Control Strategy (PCS) during tech transfer.

This presentation covers the application of the QbD principle for effective and efficient tech transfer and process characterization to complete scale-up/scale-down of bioprocesses while ensuring the safety and quality of biologics for patients.

Speaker:

Youngsun Kim
Senior Director of the Multi Modality MSAT Team, Samsung Biologics