This white paper examines how a quality by design approach is applied to technology transfer and process characterization for biologic drugs, including a monoclonal antibody case study.
Applying QbD to Tech Transfer
Defining critical quality attributes and process parameters up front makes transfer more predictable.
Process Characterization
Risk-based studies establish the design space and support a robust control strategy.
Monoclonal Antibody Case Study
A worked example shows how data-driven decisions shorten transfer and strengthen validation.
About This White Paper
This white paper is published by Samsung Biologics and curated by Biotechnology Media Insights, a trusted source for pharmaceutical and biotechnology research, technical guides and industry analysis.