conjugation process development and optimization -乐鱼全站app

home<<adc platform
  • – 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