Integrated Chemistry, Manufacture and Control

Integrated Chemistry, Manufacturing and Control

Our truly Integrated Chemistry, Manufacturing and Control capabilities fully support drug substance and drug product development and GMP manufacturing for Phase I to III clinical development programs on behalf of our partners around the world. They’ve entrusted us to deliver project success because of our Quality by Design (QbD) expertise in development and manufacturing. And because our team of multi-disciplinary, industry-leading scientists have integrated knowledge of every step in CMC development activity.

Aptuit | Integrated Chemistry, Manufacturing and Control

By choosing Aptuit, you are choosing:

  • State-of-the-art material science capabilities
  • Thought leadership on accelerated stability (“ASAP”)
  • Automated analytical data management and method development

You can rely on us to deliver Integrated CMC capabilities that tick all of your boxes.

Scientific excellence
  • 200 Experienced CMC scientists with a legacy of success, from molecule to milestone to medicines
  • Multi-disciplinary teams
  • Wide range of deliverables - from routine requests to complex requirements
State-of-the-art laboratories
  • Validated and licensed laboratories
  • ICH Stability area
  • Large suite of GMP qualified instrumentation across multiple sites
  • High level of automation and data management (LIMS)
Ability to deliver quality, reliably
  • 5 API production suites with reactors from 50L to 1600L
  • 2 DP GMP pilot plants suitable for highly potent drugs (OEB 4 and OEB5)
  • Excellent GMP inspection history