Dr. Wei Chen

1. Established the excipient control strategy for Poloxamer 188 by identifying critical quality attributes and their impact on protein formulation stability via LCCC and high-resolution mass spectrometry. Defined acceptance criteria and quality specifications to ensure consistent formulation performance across batches and supply sources. Transferred the LCCC method to the raw material supplier (BASF) for routine incoming material control, securing supply chain quality from development to commercialization. (Published results, filed patent) 2. Investigated excipient degradation (polysorbate and Poloxamer 188) causing proteinaceous aggregation in parenteral formulations. Translated this mechanistic understanding into actionable formulation and process design decisions—guiding excipient selection, defining acceptable hold times, specifying compatible contact materials, and setting storage conditions to ensure robustness throughout the product lifecycle. (Published results) 3. Supported pharmaceutical development across portfolio projects (CT-868, ABX, Faricimab, Hemlibra) by resolving particle-related quality issues from formulation screening through process scale-up. Performed root cause analyses to guide formulation optimization, primary packaging selection (e.g., silicone oil impact), and process compatibility decisions, ensuring drug product quality met specifications at each stage. 4. Developed predictive stability assessment methodologies to accelerate formulation candidate selection and de-risk scale-up. Evaluated product behavior under process-relevant stress conditions (external stress, contacting materials, excipient interactions) to enable earlier go/no-go decisions, reducing the development timeline from formulation screening to process validation. 5. Initiated collaboration with pRED to link external stress to product aggregation fingerprinting via machine learning-based particle morphology analysis.

1. Led pharmaceutical development of nanobody-based biologics from pre-clinical stage, heading 2 research associates. Designed work packages and coordinated (pre)formulation studies, lead candidate selection, and stability programs to advance molecules toward clinical readiness. 2. Identifed and nominated the lead formulation candidate using high-throughput screening — nanoDSF (thermal stability), SE-HPLC (aggregates/fragments), CE-SDS (size distribution), IE-HPLC (charge variants), and peptide mapping (DS/DP identity). Evaluated formulation robustness across excipient compositions, pH ranges, and storage conditions to de-risk the transition from pre-clinical to clinical supply. 3. Authored CMC sections of the IMPD, ensuring regulatory readiness for clinical trial application. Conducted immunogenicity risk assessments and proposed mitigation strategies based on formulation and analytical data.

1. Supported pharmaceutical development of biosimilar mAb products (Adalimumab, Nivolumab, Pembrolizumab) by developing downstream process (DSP) and analytical packages for transfer to generic pharmaceutical company clients. Hands-on downstream process development including cell clarification, TFF, chromatography, and process optimization to establish scalable purification workflows. 2. Coordinated analytical method development, validation, and transfer to ensure product characterization readiness for biosimilar comparability and release testing — peptide mapping (primary structure), disulfide bond determination (higher-order structure), released glycans (post-translational modifications), charge variants by IEC and cIEF (product heterogeneity), and ELISA for HCP and Protein A (process-related impurities). Managed method transfer to generic company partners, ensuring consistent analytical performance across sites.

1. Experience with the development of complex-sterile pharmaceuticals for long-acting release, including microparticle, nanoparticle, liposome, peptide and protein formulation from early stage to late stage. Hands-on experience in a wide range of formulation techniques, including liposome extrusion, emulsion and lyophilization. Familiar with process scale up and tech transfer. 2. Manage time-sensitive projects by leveraging both internal / external resources (CRO & CDMO) to assure quality and timelines are delivered to supply demands. Successfully achieve the registration of liposomal drug in EMA. 3. Optimize the project strategy through the concept of quality by design (QbD), foresee and mitigate the risks in project development through risk assessment and cope with failures through root cause analysis. Apply the design of experiments (DoE) to improve process / analytical reliability. 4. Well acquainted with a wide range of analytical techniques, including LC, spectroscopy (UV, IR, Fluorometry and CD), dissolution development (USP2 & USP4), peptide degradation characterization (MS), polymer characterization (NMR & GPC/FFF-MALS), particle characterization (Mastersizer, DLS and Ultracentrifuge) and protein characterization (electrophoresis, western-blot, secondary and tertiary structure analysis), stress testing and related substance characterization, as well as other extended characterization like (cryo)-TEM, SEM, confocal microscopy, NMR, SAXS and WAXS. 5. Familiar with regulations (ICH, EP & USP) and experienced with IMPD drafting (CMC), well understand the GMP concept to guarantee the quality and safety of patients by working in the GMP environment for 4 years.

1. Work in high-throughput protein analysis, integrating western-blot with microfluidic technology. 2. Develop nanoparticles and nanofibers for enzyme immobilization. Improve their catalytic stability in extremely acidic/basic and thermal conditions. 3. Employ antifouling surfaces and microfluidic system for patterning multiple types of cells to simulate cell−cell interactions in vivo.

Oligonucleotides synthesis, purification and characterization. Study in oligonucleotide-polymer interaction, protein cloning.

Study in polymer science, including biodegradable polymer synthesis, application in drug delivery and characterization.