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Biomanufacturing Services

Welcome to the homepage for Biomanufacturing Services.

 

Biomanufacturing refers to the production, isolation, and purification of biological products for therapeutic development. At BioReliance, we specialize in biomanufacturing and provide the highest quality therapeutics. Our cGMP compliant production facilities and extensive regulatory experience provide support for product development and regulatory approval.

 

Biomanufacturing Services at BioReliance consists of Master Cell Bank, Working Cell Bank, Virus Bank, and Vaccine Manufacturing.

 

1. Master Cell Bank and Working Cell Bank 

A master cell bank is critical to therapeutic development. Cell bank production from the original therapeutic-producing cell prevents genetic variation and potential contamination. Successful banks include maintenance of a single master cell line, identity confirmation, purity testing, and stability testing. Later stages in therapeutic development and manufacturing require a working cell bank to support cell-based assays.

 

We offer extensive experience in Master Cell Bank production. For more detailed information see our Master Cell Bank page.

 

2. Virus Bank

The creation of a reliable Virus Bank ensures reproducible testing and production of recombinant virus. Master Virus Seed Stocks are made from Master Cell Banks and tested for identity, purity, and stability. All testing is performed under strict cGMP conditions. Working Virus Seed stocks created from the Master Virus are fully characterized using potency assays.

 

BioReliance has produced Virus Banks for a large number of successful therapeutic projects. For more detailed information see our Virus Bank page.

 

 3. Vaccine Manufacturing

BioReliance offers vaccine manufacturing specifically designed for Phase I and Phase II therapeutic production. Our facility fully meets FDA cGMP and EU regulations. We specialize in vaccine manufacturing, gene therapy products, and large-scale production. Our clinical manufacturing projects use state of the art production devices and downstream purification techniques.

 

For more detailed information see our Vaccine Manufacturing page.