Service Scope
Our R&D department can handle gene modification and cell line development that compliments our pilot facility which can handle early stage bioprocess development up to Phase 2 GMP clinical production
Service Scope
Gene modification and stable cell lineWe can develop and optimize the gene and cell line to create the master cell bank. Our team can provide both mammalian cell and microbial system development.
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Analytical/Assay DevelopmentWe can provide analytical/assay development. We can work with our clients to ensure successful technical transfer, development, and validation of the method. We follow regulatory guidelines for the stage appropriate testing of the product.
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Process Development
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API Manufacturing
We mainly focus on production models using mammalian cell expression system. We have a capacity of 2 x 500 L with potential to expand. Using state-of-the-art production platform for cost saving and efficient manufacturing.
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Qualified QC laboratory servicesWe have qualified QC laboratory and staff available as part of the manufacturing team to validate methods, review and approve documents for product release.
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Fill and Finish
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Customize media
With our sterile and GMP facility, we can also help develop and customize GMP cell culture media for our clients needs.
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Our Cell Development and Upstream Process Tools
We have access to many different equipment for tissue culture, DNA/Protein detection, and cell detection.