Biologics

Technologies & Platforms

Purple Asymchem Long Graphic

Comprehensive, Expert Services and Solutions

From drug substance development to product development, clinical/commercial manufacturing to regulatory approval with Asymchem, you have a partner you can trust to support your efforts. Take a closer look at all we have to offer.

Analysis Development

  • Analytical method development
  • Physicochemical/structural characterization
  • Biological activity test
  • Stability activity test
  • Stability study
  • IND/BLA filing support

Cell line Development/Screening

  • Plasma transfection
  • Clone screening
  • Cone expression evaluation
  • Stability testing

Drug Substance PD

  • Cell culture PD
  • Protein purification PD

Formulation Development

  • Pre formulation & formulation study
  • Dosage comparative study
  • Primary container selection
  • Buffer screening

Filling & Lyophilization PD Platform

  • Aseptic filling
  • Lyophilization

GMP Pilot Production

  • DS & DP scale up/tech transfer
  • Process Characterization and validation
  • cGMP DS/DP pilot production
  • QC
Asymchem Biologics Tech & Platforms

Process Development & Pilot Production Platform

  • Scientific technology transfer process
  • Specialized bioanalytical development
  • Industry leading CMC/regulatory support
  • Integrated drug product development platform
  • Advanced downstream purification process development
  • High quality cell culture process development

Tried and True Quality

Reliable quality system with full compliance of ICH guidelines Q9, Q10 and cGMP principles. Our highly experienced CMC, QA, RA, PM, and technical teams are always available to support clients with full ownership and dedication.