Recombumin® Prime

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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