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Manufacturing & Support Services >> Development & Validation >> Process Development Services

Process Development Services

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From simple liquid formulations to complex emulsion or semi-solid drug products, Eurofins BioPharma Product Testing provides process development, scale-up and technology transfer support to advance your drug product through clinical trials and commercialization.

Our breadth and depth of expertise with manufacturing processes allows us to rapidly conceive and deliver creative, compliant, and cost-effective solutions to manufacturing process problems.

Scope of Services

  1. Drug Product Expertise
    1. Sterile products
    2. Lyophilization cycle selection
    3. Emulsions
    4. Nano-emulsions
    5. Semi-solids (lotions, creams, ointments, gels)
    6. Solutions (oral, topical, nasal, ophthalmic)
  1. Manufacturing Equipment
    1. Equipment evaluation and selection
    2. Equipment qualification and validation (IQ/OQ/PQ)
    3. Equipment cleaning protocols
    4. Equipment cleaning verification test method development
  1. Process Development
    1. Critical process parameter identification and evaluation
    2. Quality by design (design of experiments)
    3. Analytical testing of process development batches
    4. Technology transfer
    5. Scale up
    6. Material compatibility (vessels, filter, tubing, agitators, container/closure components)