Eurofins CDMO Alphora Inc

About Eurofins CDMO Alphora Inc

Eurofins CDMO Alphora Inc., operating as part of Eurofins CDMO, is a leading provider of Active Pharmaceutical Ingredient (API) and Drug Product (DP) development and manufacturing services for complex small molecules, including highly potent compounds.

As an FDA-approved contract development and manufacturing organization, we specialize in process chemistry, cGMP & non-cGMP scale-up and analytical method development. Through the integration of synthetic Process R&D, Solid State R&D, Pre-Formulation and Formulation Development, we offer a full suite of drug development services and manufacturing for clinical trial batches, small commercial batches and orphan drugs.

Our teams of experts in Process Research, Analytical, Technology Transfer, CMC and Project Management work closely with clients to provide phase-appropriate solutions from the pre-clinical phase through IND development and into late phase and commercial activities.

Our services include:• Drug Substance/API Development & Manufacturing
• Solid State Research & Development
• Drug P...

  • CA
  • 2015
    On CPhI since
  • 3
Contract Service
Contact info

Products from Eurofins CDMO Alphora Inc

  • Early Phase Support

    Product Early Phase Support

    From the lab to the plant:• Development of new, scalable API route options
    • Process safety and hazards assessment
    • cGMP starting material assessment& establishment of regulatory concept
    • Starting material & other raw materials sourcing and development
    • Polymorph screening & salt selection
    • Analytical method screening &preliminary stability profile
    • Pre-formulation & pre-clinical supply
  • Phase 2 Support

    Product Phase 2 Support

    Setting the stage for the commercial process:• Route or step rebuild
    • Process optimization &demonstration
    • Impurities assessment & synthesis
    • Full structure characterization &elucidation
    • Analytical method development &qualification
    • Stress studies & ICH stability standards
    • CMC gap analysis for commercialization
  • Phase 3 or Commercial Support

    Product Phase 3 or Commercial Support

    Taking the molecule to market• Fate & purge studies
    • Impurities marker synthesis &qualification
    • Design of experiments
    • Critical process parameters studies
    • Preparation for, and execution ofprocess validation
    • Continuing CMC support during &after market launch
    • Technology transfer to client’s APICMO, as applicable