• Gene modification and stable cell line
• Analytical/Assay Development
• Qualified QC Laboratory Services  
• Cell Line Storage Services
• Process Development / Production

<

>

• ​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. ​​​​

• ​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.

DNA/Protein Testing

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

Cell Testing

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

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. 

Our Capability
​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 Production​​

• Microbial and mammalian cell expression system using proprietary expression vectors for stable and efficient protein production.
  
• Disposable Technology and using state-of-the-art production platform for cost saving and efficient manufacturing.

Customize Media

• ​​Customized cell culture media development for maximum production yield.
• Flexible service charge and licencing terms and available both for R&D and GMP grade.  
  

---

---