ADC Integrated Platform

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Services
  • – Chemical based conjugation process development
  • – Conjugation process validation
  • – Enzyme based conjugation process
  • – Process development based on enzyme catalysis
  • – Exploratory ADC conjugation service
  • – Early-stage conjugation development
Advantages

– 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

– A number of successful cases of eliminating chromatography step through conjugation and UF/DF process optimization, improving yield and shortening the construction period under the premise of ensuring product quality

– Platform enables multiple ADC projects at the same time

– Multiple ADC drug development projects have been successfully delivered, supporting IND applications and clinical studies in US and China

Demonstration Case


Innovative ADC project delivered ahead of project schedule

– From project kick-off to successful completion of pilot GMP manufacturing and IND submission, the project was completed 6 months earlier than customer expectation, and the achievement was highly recognized



Solutions
  • 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

– Communicating with the customer actively and completing the project six months ahead of schedule

– The innovative ADC project was rapidly developed from lead candidate to IND filing, breaking through the difficulties of platform process and analysis methods

Laboratory