Bingquan (Stuart) Wang

1. Provide project leadership supporting IND and BLA enabling early and late stage product development CMC activities. 2. Collaborate with functional areas to ensure successful execution of various CMC projects and delivery of results on time with high quality. 3. Coordinate efforts and facilitate communication to ensure alignment between WuXi Biologics and clients. 4. Provide leadership in development and manufacturing alliance management, product development and manufacturing strategy.

Drug Product Process Development, Moderna Therapeutics Development of Lyophilized Formulations and Fill/Finish Processes to support clinical manufacturing of mRNA products

Led drug product Chemistry, Manufacturing and Controls (CMC) activities for a program ranging from clinical to process validation. Coordinated the necessary Formulation and Process Development studies for a high concentration MAb liquid product in different container closure systems, and designed the Fill/finish process based on disposable system. Acted as DP lead and coordinated within matrix environment to finalize DP development strategies, process validation strategy, risk mitigation plans, and communicated effectively between stakeholders/customers. Defined the manufacturing process control strategy based on the QbD approach, and authored and reviewed the process characterization studies, process validation documents and supported process validation runs at CMO.

Authored the Formulation Development and Fill Finish Process Development sections of regular Filing document for BLA, MAA and PMDA in major markets including the USA, EU, and Japan. Prepared responses to address the late-cycle review questions from FDA and led additional process qualification studies, which resulted in successful licensure. A manager responsible for formulation and lyophilization process development for several parenteral protein pharmaceuticals, in different containers (vial, Dual Chamber Syringe/Catridge, etc). I also lead various Chemistry, Manufacturing and Controls (CMC) activities at all life cycle stages ranging from clinical through commercial life cycle management, and manage the budget and direct reports. Led the Technology Transfer and Process Validation of lyophilized parenteral manufacturing processes to Contract Manufacturing Organizations (CMOs). Developed design space based on scale down models with mathematical modeling to aid in Quality by Design (QbD) activities that reduce timeline and financial risk during scale up and tech transfers. Scale up of lyophilization process by performing rational equipment characterization. Proposed several Technology Investigation projects and managed to get funding for internal technology evaluation, and also collaborated with external organizations on innovative approaches to handle technical challenges.

• Performed various development studies to justify biologics formulation, stability and raw material usage • Designed experiments to optimize formulation, Shipping, Fill and Finish process for phase III, and drafted the CMC section for regulatory filing. • Developed multiple product contact compatibility and stressed stability studies to support Fill/finish/lyo Tech Transfer to CMO and internal fill sites to meet Consent Decree timeline. • Evaluated the critical impact of VPHP on product quality during the filling process in an isolator • Led the development and qualification of Lyo scale-down model for multiple commercial products • Hands-on Experience in supervising a formulation/fill/finish group with budget planning, project management, team coaching, instrument maintenance and lab safety.

• Led a QbD study project for a commercial product. Performed risk assessment, scale-down model qualification, screening and optimization DOEs and data analysis for a rational development of lyophilization design space. • Performed several investigations on /Fill/Finish/Lyo process deviations to support regulatory filing. • Acted as the technical leader for a manufacturing capacity expansion project to demonstrate the comparability of different filling lines/lyophilizers, and received agreement from regulatory agencies on the proposed Rapid Process Validation approach. • Developed multiple product shipping/filling/shear stress studies to support Tech Transfer to fill/finish manufacturing sites.

• Developed protein formulations for a very low concentration protein to overcome the instability issues associated with free subunit dissociation. • Optimized lyophilization cycle to enhance the protein stability and scale up to pilot scale freeze dryer. • Established solid state characterization lab (DSC, FTIR, XRD, KF) to support formulation development and comparability evaluation of finished commercial products. • Led multiple investigations for Purification/lyophilization process deviations . • Performed extractable/leachable study on new filter and filling tubing to support manufacturing activities.

• Developed formulations and lyophilization cycles for an IgG1 monoclonal antibody, three IgG1 fusion proteins, human growth hormone (hGH), recombinant Human serum Albumin (rHSA) and two cytokines. • Studied the impact of sucrose level on protein stability, protein-sugar interaction and glass dynamics, and investigated the relationship between stability, protein native structure and (global and local) mobility. • Investigated novel concepts to improve the storage stability of lyophilized drugs using thermal treatment step during the 2nd drying cycle. • Developed protocol to measure the density of amorphous solid utilizing helium pycnometer, and predict long-term stability from the free volume of the sample. • Performed several outsourcing projects from large pharmaceutical companies for quality assurance. • Train fellow graduates students and visiting scientists on skills in formulation characterization (FTIR, concentration, purity, DSC, DTA and ITC etc).

Develop DNA sensor for the high-throughput screening of toxic drug and carcinogens

Protein formulation optimization Freeze drying cycle development Biophysical characterization of proteins