Formulation Development

Formulation Development
Product Description

Our Formulation Scientists and Process Engineers are experts in poorly soluble compounds and high containment operations. Our formulation development lab and pilot plant suites are specifically designed for high containment and outfitted with cGMP matching technologies. We follow a data driven approach to clinical formulation development.Formulation Services Capabilities:
• Particle Size Reduction - Wet Nanomilling, Jet Mill Micronization
• Method Development and Validation
• GLP Formulation Support
• Liquid and Suspensions
• Excipient Compatibility
• Poorly Soluble Compounds
• Amorphous Dispersions
• Prototype Stability

Eurofins CDMO Alphora Inc

  • CA
  • 2015
    On CPHI since
  • 3
    Certificates
Company types
Contract Service
Manufacturer/Innovator

Eurofins CDMO Alphora Inc

  • CA
  • 2015
    On CPHI since
  • 3
    Certificates
Company types
Contract Service
Manufacturer/Innovator

More Products from Eurofins CDMO Alphora Inc (8)

  • Drug Product Development & Manufacturing

    Product Drug Product Development & Manufacturing

    We can rapidly develop a formulation that is best suited for your drug development program and provide submission-ready documentation.
    If you are developing a new drug product or reformulating an existing drug, our team is composed of experts in oral liquid and solid dosage forms, parenteral formulati...
  • Biologics - mAbs, therapeutic proteins and ADC development

    Product Biologics - mAbs, therapeutic proteins and ADC development

    Eurofins CDMO Alphora Inc. provides integrated solutions for small molecules, drug product, biologics and phytocannabinoids. Specializing in complex and niche small molecule drug substance and drug product services, including high potent capabilities, we provide support from preclinical to commercial devel...
  • Small Molecule - Early Phase to Phase 2 Support

    Product Small Molecule - Early Phase to 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 st...
  • Small Molecule - Phase 3 or Commercial Support

    Product Small Molecule - 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
    • Technolog...
  • API Development Services

    Product API Development Services

    Eurofins CDMO is an FDA-approved contract development and manufacturing organization (CDMO) focused on process chemistry, cGMP scale-up and analytical method development for complex, small molecule APIs, including highly potent molecules. Our talented team of Process Research, Analytical, Technology Transf...
  • cGMP Manufacturing Services

    Product cGMP Manufacturing Services

    Our Operations team has extensive experience in cGMP clinical drug product manufacturing. Our state-of-the-art facilities and cGMP compliant systems are specifically designed for quick-to-clinic operations. Eurofins CDMO’s team of Engineers, Technology Transfer specialists, and Scientists specialize in pro...
  • Pre-Formulation Services

    Product Pre-Formulation Services

    A wide range of IND enabling drug product services are provided at Eurofins CDMO. Our PhD scientists have extensive experience in material characterization, analytical chemistry and strategies for developing poorly soluble compounds. Our Pre-Formulation laboratory is fitted with a suite of specialized equi...
  • Solid State Research & Development Services

    Product Solid State Research & Development Services

    Eurofins CDMO provides expertise and services in physicochemical characterization of API and intermediates, screening for different API solid forms and salts as well as crystallization process development.

    We apply High-Throughput Screening Technology (HTST) for expeditious discovery of new poly...

Eurofins CDMO Alphora Inc resources (2)

  • News Sip N' Science Mixer with Eurofins CDMO Alphora Inc.

    Join us for an afternoon of science, cocktails and networking at our Sip N Science Mixer on Wednesday, May 9 from 2:00 pm - 4:00 at Booth#414. 

    We look forward to seeing you there!
  • Brochure Analytical Services 2021

    Eurofins CDMO offers analytical services as part of API development as well as stand-alone analytical testing services for projects at various stages in the drug life cycle (pre-clinical to late phase). Our analytical scientists specialize in the development of analytical methods and phase appropriate specifications to ensure control of the synthetic process and quality of API throughout the program.