The Quality Control Laboratories (QC Labs) consist of areas for cell line quarantine, cell bank storage, sterility testing, microbiology testing, biological testing and chemical testing. In addition, the QC Labs are fully equipped to test for water quality and environmental parameters, as well as raw materials, in-process and final product.

Quality control programmes have been put in place to ensure that methods are qualifield and validated. We also use compendial analytical methods where possible.

The QC Labs testing capabilities include:

• Appearance
• Aggregates
• pH
• Sterility
• LAL Endotoxin
• Protein concentration by A280
• Potency, Biological activity (product specific)
• Identity & Purity
• Protein A contaminant
• Host cell protein contaminant
• Residual DNA contaminant
• Carbohydrate analysis
• Immunoglobin class & subclass
• Mycoplasma by ELISA
• Microbiological ID
• Peptide mapping