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Product Testing >> Services >> Manufacturing & Support Services

Manufacturing & Support Services

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From formulation development, process development, technology transfer and analytical method development to GMP drug product manufacturing and clinical packaging, Eurofins BioPharma Product Testing provides development and manufacturing support to help progress your Active Pharmaceutical Ingredients (APIs) into Finished Dosage Forms (FDFs) for use in clinical trials.

For projects in all phases of clinical development, we deliver compliant, responsive, agile, cost-effective, and highly-flexible development and manufacturing options for drug products, medical devices, APIs, reagent supplies, and diagnostic kits.

Why Choose Eurofins BioPharma Product Testing?

  • Our small scale GMP manufacturing services, coupled with comprehensive testing services, allow us to serve as your sole outsourcing partner guaranteeing clear communication and confidentiality.
  • With 25 laboratories worldwide, the size and diversity of our network of laboratories allow us to guide you through the full process product development and small scale manufacturing.
  • Our customized approach and flexibility allow us the opportunity to offer tailored solutions for unique, specialized needs.

Scope of Services

  1. Development and Validation
    1. Formulation Development
    2. Process Development, Validation & Technology Transfer
    3. Analytical Method Development, Validation & Transfer
  1. Manufacturing
    1. Aseptic Fill & Finish of Sterile Products
    2. Manufacture of Non-Sterile Products
  1. Finished Drug Product Support
    1. Product / Process Troubleshooting
    2. Packing & Labeling
    3. Storage & Distribution
    4. Batch Release Testing (Certificate of Analysis)
    5. Stability Testing
    6. Qualified Person (QP) Release (Certificate of Conformity)

Facilities

Eurofins BioPharma Product Testing has GMP-compliant manufacturing facilities in the US and Europe.

Our 1,400 ft2 manufacturing suite in San Diego, CA, is equipped with an ISO 8 (Class 100,000) clean room, ISO 8 ingress/egress area, HEPA filtered clean-up area and material storage/dispensing area, as well as two, 300 ft2 non-classified manufacturing rooms.

Manufacturing Equipment and Utilities in San Diego, CA, US

  • DI water (meets USP specs)
  • Clean, dry, oil-free compressed Air
  • Backup generator
  • Laminar-flow dispensing booths
  • Balances (up to 60-kg)
  • Stainless-steel jacketed vessels
  • Temperature controllers (heater/chiller)
  • Tube filler (aluminum and laminate tubes)
  • Stainless-steel jacketed 200-L mixing vessels with double-action mixers
  • Glass jacketed 10-L and 20-L reactors
  • Ball mill
  • Sieves
  • Drying ovens
  • Stirrers, mixers, and other support equipment

Eurofins Sinensis houses GMP manufacturing activities with clean room suites totaling 861 ft², as well as an isolator for dealing with highly potent compounds such as hormones and cytostatics.

Manufacturing Equipment and Utilities in Leiden, NL

  • Millipore Integritest 4N instrument
  • Masterflex pump
  • Label printer
  • Mobius mixer (uses 10, 50 and 100 liter disposable bags)
  • Balances
  • Floor scale (2 – 300 kg)
  • Industrial sealer
  • Stirrers, mixers and other support equipment
  • Autoclave
  • Dry heat oven
  • Biosafety cabinet located in a Class B area
  • Biosafety cabinet located in Class C area
  • Biosafety cabinet for feasibility purposes
  • Isolator for highly-potent compounds
  • Sonicator
  • Compressor