Early Phase Support

Early Phase Support
Product Description

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

Eurofins CDMO Alphora Inc

  • CA
  • 2015
    On CPhI since
  • 3

Eurofins CDMO Alphora Inc

  • CA
  • 2015
    On CPhI since
  • 3

More Products from Eurofins CDMO Alphora Inc

  • 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
  • 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 Transfer, CMC Specialists and Project Managers have supported clients from the pre-clinical phase through IND development, into late phase and commercial activities. Our work spans from route selection to process and analytical development, to non-cGMP and cGMP scale-up. Eurofins CDMO also supports criticality assessment and mitigation, CMC filing support, and supply chain management. We work closely with clients to provide phase-appropriate solutions to balance their immediate and long-term API development needs.
  • 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 equipment focused on solubility, absorption and In-Vitro/In-Vivo correlation studies. Our capabilities include:• Solubility & Absorption Studies - Pion Inc. Suite of Equipment(μDISS, μFLUX, Macro DISS)
    • Salt and Polymorph Screening; Excipient selection and screening
    • Prototype Stability - ICH Stability (Temperature, Humidity and Photo)
    • GLP Formulation Support - Formulation Preparation and Analysis
    • Stability Indicating Assay and Cleaning Method Development
    • Physical Characterization
  • Formulation Development

    Product Formulation Development

    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
  • 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 process transfer and scale-up strategies, providing a seamless transition of programs from development through cGMP manufacturing.cGMP Manufacturing Services Capabilities:
    • High Containment Operations
    • cGMP Clinical Manufacturing (Oral Dosage Forms)
    • Nanomilling - Wet Milling
    • Micronization - Jet Milling
    • API-in-Capsule
    • Encapsulation and Tableting
    • Liquid and Suspensions
    • Amorphous Dispersions
    • cGMP Stability and Drug Product Release
    • cGMP Storage and Distribution
  • 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 polymorphs, pharmaceutical salts, solvates and co-crystals. Some of the benefits of the HTST include a reduction in cost, manpower, time and a 100s-fold reduction in API quantities required for screening studies.

    We also offer particle size engineering and polymorphic control through our crystallization process development. 

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