ADC Platform

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  • – Chemical based conjugation process development
  • – Site specific conjugation
  • – Process Characterization
  • – Enzyme based conjugation
  • – Exploratory ADC conjugation service
  • – Process Validation

– Platform-based, flexible and fast conjugation process development

– Customized robust conjugation process development strategy based on Quality by Design (QbD) concept

– Complete downstream purification process development and flexible development strategies

– Multiple successful cases optimizing purification through conjugation and UF/DF processes, ensuring quality while boosting yield and speeding timelines

– Concurrently execute multiple ADC drug projects with quality assurance

– Successfully completed multiple ADC projects for clinical submissions in both the US and China

Demonstration Case

Innovative ADC project delivered ahead of project schedule

– Project completed 6 months ahead of schedule from kick-off to pilot GMP manufacturing and IND submission, with recognized achievement

  • Efficient execution: Starting from laboratory-scale process development, quickly complete the target quality profile study and process development risk assessment
  • Cost reduction and efficiency increase: Quickly develop innovative non-traditional process routes for customers, effectively shorten process time and achieve cost savings
  • Solid CMC capabilities: Solve process and quality control difficulties through the seamless connection between conjugation process development and quality analysis
  • Stable process scale-up: Successful scale-up from process lock to manufacturing in first-time success

Project highlights

– Innovative ADC project swiftly progressed from lead candidate to IND filing, overcoming process and analysis challenges. Actively communicated, project completed six months ahead of schedule