Our Facility
Adelaide Facility
The facility has been inspected and approved by the US-FDA and Australia’s TGA and manufactures with strict adherence to regulatory requirements. In addition, our team has supported successful product approvals from EMA and Health Canada.
Our Adelaide facility is ready for your contract development and manufacturing needs for both clinical and commercial products.
Site History
Originally built in 2003, and extensively upgraded in 2016, the facility is state-of-the-art, with modern cleanrooms and up-to-date utilities.
The 4500 m² cGMP facility and laboratories provide a manufacturing environment that supports production of multiple products, across multiple stages of manufacturing from clinical to commercial.
The facility houses advanced equipment and technologies that provide flexible manufacturing options to meet our customer’s needs.
cGMP Equipment and Technology
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Cell Banking Suite
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Upstream Fermentation
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150-500 L working volume fermenter
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Midstream Purification
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Continuous flow centrifuge
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High pressure homogenizer
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Downstream Purification
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2,900L refold tank
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Isocratic and gradient chromatography skids and columns
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Tangential flow filtration system
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Bulk Filling
cGMP Warehouse
The offsite warehouse houses a fully functional cleanroom which was designed for the purpose of raw material sampling.
This state-of-the-art cleanroom was designed and operated to be compliant with regulatory requirements for cGMP manufacturing.
