Our Capabilities/Services

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We support our clients through the drug development journey from early phase process development to commercial manufacturing.

Process Development

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Gallus has been producing biopharmaceutical products for the last 26 years and has significant experience with mammalian cell culture...

Analytical Method Development

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Gallus offers analytical development services to support process improvements and develops and performs assays for product characterization...

Process Validation

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Gallus works with its clients to design and generate a Validation Master Plan for their late-phase products. Gallus provides a full array of studies for characterization...

Quality/Regulatory

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The Gallus manufacturing facility is a licensed, multi-product commercial manufacturing facility has been inspected and approved by the FDA, EMA, PMDA, ANVISA and Health Canada.

cGMP Manufacturing Services

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The Gallus cGMP manufacturing facility has been manufacturing commercial products for more than 10 years and is conveniently located near the airport in St. Louis, MO.

Stability, Cell Banking and Storage

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Gallus offers cGMP stability testing and cGMP product storage to its clients for testing stability of intermediate hold times and shelf life of drug substance...

Fill/Finish

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Gallus has an ISO 7 filling area to support early clinical supplies.

Project Management

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The Gallus site has successfully managed 40+ mammalian cell-culture development products in the last decade.