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 line

​We  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. ​​

Analytical/Assay Development
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​We 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.

Process Development
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We  have many years of bio-pharmaceutical scale-up, optimization, and technology transfer experience.  This includes upstream cell culture scale-up to downstream purification process that meets GMP standards. 

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. ​

Qualified QC laboratory services

We have qualified QC laboratory and staff available as part of the manufacturing team to validate methods, review and approve documents for product release. ​

Fill and Finish
​

We have a fully enclosed sterile filling capability. We also perform packaging within our clean room facility.  ​

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.