Manufacturers must provide quality control test results for evaluation and approval on their licensed drug products and associated components from the regulatory authorities before they are released in the market.
With an extensive experience with DNA, RNA, Protein and primary human cells cultivated in our own cell culture media formulations (interference-free and controlled culture medium), we provide customized service for method feasibility, development and optimization using GLP 21CFR part11/EU Annex 11 complaint instruments and transfer them to your CMO partner site or to your site.
• Onsite training and method transfer along with detailed SOPs
• Flexible to use most brand instruments (that your CMO partner/you have) that helps you to save time in easy transfer of methods
• Several established primary human cells like HUVEC, microvascular endothelial cells, epithelial cells that are ready to setup an assays • We can utilize cell lines or reporter cell lines that are commercially available that fits your needs
Figures: 1. Adult human epithelial cells grown in a fully defined, and not containing any animal or human components, phenol red, hormones, unphysiological components or inducers. 2. Adult human microvascular endothelial endothelial cells grown in a serum free medium
Following are some of our bioanalytical services for therapeutic antibodies and biologics
A. Potency and functional Characterization
Antigen specific immune Reponses, Proliferation assays, Cytotoxicity assays (ADCC, CDC, ADCP), Cytokine release assays, Neutralization assays, Apoptotic assays, Binding assays
B. Protein Analytics
Host cell DNA or Protein determination, Protein concentration, Endotoxin