In order to ensure patient safety, the regulatory authorities recommend the detection and the quantification of impurities in biological products for therapeutic use. The potential contaminants include host cell DNA and host cell proteins (HCP) from the production cell line and proteins from the culture medium and the purification process.

 

 

 

 

• Residual DNA qPCR assays:

 

  

- Hamster (CHO)

 - Human (HEK293, MRC5)

 - Monkey (VERO)

 - Mouse (Sp2/O)

 - Avian (duck and chicken cells)

 - Insect (Sf9, Sf21)

 - Bacteria (E.coli)

 - Yeast (Pichia pastoris)

 

 

 

• Residual proteins ELISA methods:

 

 

 

1. Host Cell proteins (HCP):

  

 - Bacteria (E.coli)

 - Hamster (CHO)

 - Human (HEK293, A549)

 - Mouse (NS/0)

 - Yeast (Pichia pastoris)

 

  

1. Others impurities:

 

 - Benzonase^®

 - Bovine Serum Albumine (BSA)

 - A protein

 

  

 

Please, click on the titles to download our technical sheets and know more about our methods