Late Stage Development and Commercialization

WuXi Biologics late-stage development program adheres to rigorous scientific standards and a highly-detailed methodology in order to meet the eventual regulatory scrutiny upon BLA filing. To ensure your product reaches its potential in terms of safety and efficacy, we lay down the foundation for quality early on in the commercial process development and optimization phase.

By identifying the presumptive critical quality attributes (CQAs) that affect potency, safety, and product quality, we perform process characterization to better understand and confirm the process and refine CQAs. Key process parameters need to be defined by failure mode and effects analysis (FMEA). Through design of experiment (DoE) and/or one-factor-at-a-time (OFAT) methods, we characterize each process step by using qualified scaled-down models. A final FMEA is then conducted to fully understand and confirm CQAs, and to define the control strategy, which ensures process readiness for the process performance qualification (PPQ).

Process Performance Qualification (PPQ) demonstrates the validity of the process design and the suitability of the process control strategy at the commercial manufacturing scale. All critical aspects for PPQ readiness utilize our extensive in-house qualification and validation programs and enable a right-first-time approach.

• Process description and control strategy are ready with parameter classification, defined proven acceptable ranges (PARs) and normal operating ranges (NORs)
• Analytical methods validation for all in-process control and release testing. Specification, reference standard, comparability and stability programs are in place
• All raw material and excipients testing follow ICH guidelines, and the bill of materials (BOM) and testing strategy are defined along with materials are ready and released
• Facility Readiness includes all facilities, utility, instruments and equipment qualification/calibration
• Documentation Readiness across all PPQ plan and study protocols, manufacturing batch records and SOPs, and AMPs
• Training of operators and the development of standard operating procedures (SOPs) to ensure Operation Readiness and cGMP compliance

All critical aspects for PPQ readiness utilizing our extensive in-house qualification and validation programs enable a right-first-time approach including our comprehensive raw materials control system that has passed 30 global regulatory agency audits

Our one-stop shop approach includes a myriad of specialized capabilities designed to minimize risk and expedite your timeline to BLA filing.

To provide you with a global supply network, WuXi Biologics operates multiple state-of-the-art, premier quality cGMP drug substance (DS) and drug product (DP) facilities across five countries. With 14 DS facilities worldwide, our GMP drug substance manufacturing capacity is over 260,000 L and growing to over 580,000 L across five countries after 2026. We currently maintain 9 drug product facilities capable of conducting liquid or lyophilized fills at varying clinical and commercial scales and utilizing a variety of container and closure system (CCS) configurations that include vials, prefilled syringes and other combination product CCS.

All of our manufacturing operations are overseen by our comprehensive global Quality System that has been audited by multiple regulatory agencies including the FDA, EMA, NMPA, PMDA, MFDS, HSA, ANIVSA, HPRA and Health Canada.