Late Stage Development and Commercialization
WuXi Biologics provides one-stop, high-quality late-phase development and manufacturing services for companies looking to bring biologics and vaccines to the market. Through our highly-vetted development platforms designed to accelerate your product through all aspects of the late phase process, assay and formulation development, optimization, characterization and validation, we bring your projects ready for BLA filing in just 15 months or less. Additionally, our extensive global drug substance and drug product supply network provide the necessary GMP manufacturing capacities to supply commercialized products on a worldwide scale once your are ready to move beyond the BLA phase. Whether you are developing products from mammalian cell culture, microbial fermentation or via in vitro methodologies (e.g., for RNA-based vaccines), let our experienced teams help you meet your critical BLA filing milestones.
Essential Program Activities:
We utilize life cycle management and Quality-by-Design principles as outlined by the ICH guidelines as the fundamental backbone to all our process development (PD), process characterization (PC) and process performance qualification (PPQ) activities and couple that with ALCOA+ data integrity principles to provide you the highest quality late-phase development program.
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.
- Working cell bank (WCB) creation and testing
- End of production cell bank (EOPCB) characterization
- Genetic stability testing
- Assay optimization and method validation
- Product characterization and extended characterization (Forced degradation study, comparability, fractionation and characterization)
- Project specific HCP assay development and reagent generation
- Cell-based bioassay development and validation
- Upstream and downstream process development and optimization
- Formulation development and optimization (liquid, lyophilized, for both vials and pre-filled syringe products)
- Scale-down model qualification
- Process characterization to establish the proven acceptable range
- Resin and membrane lifetime studies
- Viral clearance validation
- Unprocessed bulk testing
- DS and DP process validation package and the supporting studies
- Process Control Strategy
- Mixing validation study
- Cleaning validation
- Microbial hold study
- Impurity clearance study
- Extractable and leachable assessment
- Simulated shipping studies
- Shipping validation
- Media fill /aseptic process simulation
- Filtration Validation
- CMC dossier preparation and regulatory support
- Continued process verification
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.
Our Keys to Achieving Faster Timelines
With state-of-the-art equipment and facilities at our disposal along with hundreds of industry veterans each with 10-30 years of experience, our highly-trained scientists leverage the extensive resources and industry-leading expertise to perform all program activities at accelerated speeds. Through our single-source approach and global manufacturing capacity, customers benefit from having no project handovers and a single project management system. The plug-in-play study design and documentation system along with our deep process understanding allows us to provide a more efficient project start and in parallel, use our highly-vetted development platforms to execute risk-based activities. Lastly, we take a scale-out manufacturing philosophy and utilize single-use technologies to reduce scale-up risk in cell culture processes and cleaning validation workload.
Our extensive resources, expertise and risk-based approach led to an unprecedented expedited timeline from DNA to EUA for a client’s late-stage COVID-19 program.