:Contract Manufacturing Solutions

Contract Manufacturing Solutions

Your Design, Our Execution!

AmericanBio offers unique expertise, experience, and our Operational Center of Excellence in the support of our customer’s reagent strategies. For product launches, process improvements, scalability, SKU rationalization, hemispheric strategies, make/buy decisions and more, you can rely on our design Engineers to work with you on the seamless integration of your product. We are a registered small business providing greater flexibility and agility. This improves your speed to market and your expected revenue stream.

  • Product Development Support to compliment your design
    • Stability Studies, Real Time and Acceleration
    • Validation
    • Qualification
  • Custom Manufacturing and Custom Packing of Reagents and Buffers
    • From custom buffers to sophisticated and complex reagents and kits
    • Aseptic Manufacturing and Handling Techniques
    • No Minimum Order Quantities
    • Expertise in Molecular Biology, Diagnostic and Molecular Diagnostic solutions
    • Competency in LDT development and CLIA requirements
    • Documentation Development and Generation
    • Sample and Qualification Lot Fulfilment
    • Manufacturing and QC Protocols capture your design inputs
    • Label Design including Barcoding
    • Specification Development
    • We will build product using your existing supply chain eliminating requalification
    • Send us your formulations and we will dose/dispense
  • Kit and Assembly Support
    • Consumable Management
    • Develop and Design Footprint of Kit
  • Engineering Support for consumable design
  • Project Management utilizing Teamwork software to drive your project through transfer into our Operation
  • State of the Art Water System for manufacturing
  • ISO Class Operations
  • Packaging Flexibility – Tubes, Vials, Bottles, Bags, Plates, Drums, Cartridges, On Board Reagents and more
  • Quality Control – Analytical, Functional, In Process, Final QC
  • Documentation - Full Traceability
  • SDS Creation - Ability to create Safety Data Sheets in 127 different languages
  • Examples of Products Made For Our Customers:
    • Wash Buffer, Lysis Buffer, Binding Buffer
    • Sample Prep Solutions, Hybridization Buffers
    • Purification Buffers, Custom Alcohol Blends
    • Custom Detergent Solutions, NGS Reagents and Libraries
    • Custom Media Formulations, FISH Reagents
    • Genetics and Epigenetics Reagents
    • Immuno Reagents, ELISA Reagents
    • Biomarker, Exosome and Liquid Biopsy
    • PCR Reagents and MORE!!!
    • RUO, IVD, CLIA and LDT
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