HJB - Your Trusted Biologics CDMO Partner
HJB, CDMO, biologics, HJB Bio, hjbbio, China CDMO, 杭州奕安济世, Just Bio, Just biotherapeutics, HJB bio, HJB China, Hangzhou HJB
We apply solid scientific principles, prior knowledge, and effective risk management strategies, to achieve in-depth understanding of both the product and its manufacturing processes. We focus on continuous improvement in late-stage development by optimizing process and formulating robust control strategy to maximize productivity, lower COGs and most importantly, ensuring consistent high product quality, ultimately paving the way for a smooth and effective path to market.
We approach late-stage development with a steadfast commitment to scientific rigor, following a systematic methodology designed to meet the stringent regulatory requirements of BLA. By establishing QbD during commercial process development and optimization, we ensure your product achieves its full potential in terms of safety and efficacy.
By identifying the potential critical quality attributes (pCQAs) that may impact efficacy, safety, and overall product quality, we conduct comprehensive CQA assessment and process characterizations. This process enhances our understanding of the manufacturing process while refining the CQAs. Key process parameters are determined using failure mode and effect analysis (FMEA). Utilizing Design of Experiment (DoE) and/or one-factor-at-a-time (OFAT) approaches, we thoroughly characterize each process step using qualified scaled-down models. A final risk assessment is performed to validate the CQAs and establish a robust control strategy, ensuring process readiness for process performance qualification (PPQ).
A successful PPQ validates the process design, confirming that the commercial manufacturing process performs as intended. Clear and well-defined workflows are critical to ensuring tasks are executed accurately and efficiently, laying the groundwork for consistent commercial manufacturing operations.
Process Validation Workflow:
CDMO@hjbbio.com
Process Characterization for Downstream 