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. ​​​​

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Analytical/Assay Development

• ​Provide analytical/assay development. 
  
• Work with our clients to ensure successful technical transfer, development, and validation of the method. 
  
• Follow regulatory guidelines for the stage appropriate testing of the product.

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Qualified QC Laboratory Services  

DNA/Protein Testing

• Western Blot
• IEF
• Sterility (BacTalert)
• HPLC
• Sequencing

Cell Testing

• Cell Identification
• Viable Cell Count
• Endotoxin
• Sterility Test (BacT Alert)

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Cell Line Storage Services

Secure Cell Storage

• Reliable Cell Line storage under Cyro condition.
• Backup utilities and 24 x 7 real time monitoring
• Internal Security Control
• Support by regular physical, biological and potency testing to ensure product quality

Stability Testing

• Drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life.
• We provide Stability Studies for drug substance, such as protein and cell with reference to ICH guidelines. Provide storage conditioning chamber at conditions under liquid nitrogen, at -80°C, -20°C, 2-8°C and 25°C. 

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