Biotech Solutions

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End-to-End Know How Delivers a One-Stop Advantage

At Asymchem we’re ready to partner with you to develop and manufacture biologics from concept to commercialization. Our in-depth experience is revealed in our R&D-to-process innovations, in our proven reputation for manufacturing safely and at scale, and in our mastery of regulatory concerns. Our expertise navigating the complex global regulatory arena is an especially valuable advantage to existing and emerging biotech companies.

Comprehensive Service Offerings to Match Your Needs

  • Pre-clinical R&D
  • Technology transfer
  • Integrated quality system
  • Process development, optimization, and validation
  • Drug substance development
  • Formulation development
  • Drug product development
  • Fill and finish — both aseptic and lyophilization
  • GMP pilot production
  • Clinical and commercial manufacturing
  • Analytical support
  • Regulatory support
  • Downstream purification process development
  • Cell line development and screening
  • Cell culture process development
  • Commercial licensed cell line

Proven Technology and Platforms

  • Analytical development
    • Analytical method development
    • Physicochemical/structural characterization
    • Biological activity test
    • Stability study
    • IND/BLA documentation and filling support
  • Cell Line development and Screening
    • Plasmid transfection
    • Clone screening
    • Clone expression evaluation
    • Stability testing
  • Drug substance development
  • Formulation development
    • Pre-formulation and formulation study
    • Dosage comparative study
    • Primary container selection
    • Buffer high-throughput screening
  • Pilot production
    • Drug substance (DS) and drug product (DP) scale up and tech transfer
    • Process characterization and validation
    • DS/DP pilot production
    • Quality control