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Process Development

Welcome to the homepage for process development.

 

In general, process development is a comprehensive step-by-step process that guides you from your starting point to your desired goal. In biomanufacturing, that goal is a reproducible and active therapeutic made in the desired quantity. Process development is the optimization of scale-up and purification that is required for therapeutic production.

 

At BioReliance, we specialize in process development and provide the highest quality therapeutics. Our cGMP compliant production facilities and extensive regulatory experience provide support for product development and regulatory approval.

 

Process development at BioReliance consists of Serum Free Adaptation, Virus Production, and Downstream Purification.

 

1. Serum-Free Adaptation

 

Serum-Free adaptation of mammalian cell cultures makes scale-up and production easier. Adapting a mammalian cell away from undefined serum components is an FDA regulation. Standardization of the media improves reproducibility and decreases contamination. Serum-free adaptation can be performed by direct adaptation or sequential adaptation. In addition, BioReliance has experience converting cultures from adherent monolayers to cell suspension cultures, which also is advantageous to scale-up technologies like bioreactors and cell factories.

 

We offer extensive experience in Serum-free adaptation. For more detailed information see our Serum-free adaptation page.

 

2. Virus Production

 

Custom virus production encompasses both viral expression and virus purification. This process is a critical component of assay design and biologic production. BioReliance can grow and purify many different types of viruses from multiple mammalian cell lines. We offer a variety of viral recognition assays to ensure viral expression and isolation. Our viral purification process involves exhaustive sterility testing on every custom virus product.

 

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

 

3. Downstream Purification

 

Downstream processing and downstream purification can be the rate-limiting step in therapeutic production. These techniques are becoming more important as higher titer protein therapeutics are produced. An efficient system of downstream purification ensures the required purity and yield of a therapeutic, at a given scale. BioReliance offers numerous techniques for downstream purification including resin chromatography and membrane chromatography with multiple chemistry types available. BioReliance has performed hundreds of successful downstream purification projects.

 

For more detailed information see our Downstream Purification page.