Recombumin® Prime recombinant human albumin is a multifunctional excipient, ancillary and raw material, manufactured to ICHQ7 cGMP and USP-NF standard.

Recombumin® Prime has multiple applications in cell therapies, gene therapies, viral-based therapies, vaccines, medical devices and diagnostics. A Recombumin® Prime sample contains 1g of recombinant albumin in 5ml and is suitable for initial evaluation and research use only.

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Recombumin® Prime is a multitool for biopharmaceutical, vaccine, diagnostic, and medical device manufacturers, offering benefits through various applications. Recombumin® Prime has been utilized in a vaccine manufacturing process to deliver over 200 million doses of paediatric vaccine alone, as well as being used in various marketed, pre-clinical and clinical phase treatments, and medical devices.

Key Features

  • Security of supply | Recombumin® can be shipped worldwide*.
  • Batch-to-batch consistency | Reducing process variation, which affects HSA (human blood product) users.
  • Regulatory support for the product | The Recombumin® portfolio is supported by a comprehensive regulatory package and filings in key markets globally.
  • Market experience | Dosed well over 200 million times in a paediatric vaccine product and used in licensed and marketed therapeutics & medical devices; be confident in the safety and performance of Recombumin®.
  • Recombinant | 100% animal and human origin free and chemically definedICHQ7 cGMP manufacturing standard | The Recombumin® portfolio delivers unsurpassed quality and has never been the subject of a product recall.
  • USP-NF | From the only USP-NF compliant recombinant human albumin portfolio; Recombumin® Prime supports product development acceleration reducing time required for testing.
  • Drug Master Files | Extensive regulatory packages and experience supports products from the research lab to the clinic.

Recombumin® Prime Supports in the Manufacture of:

  • Cell therapies
  • Gene therapies
  • Protein based therapies
  • Viral based therapies
  • Vaccines
  • Medical devices
  • Diagnostics

Example Workflow Applications:

  • Media and buffer preparation
  • Cell selection
  • Transduction
  • Expansion
  • Differentiation
  • Harvest
  • Cryopreservation
  • Excipient
  • Biological

*Excluding Russia"

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