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Process-Related Impurity Detection​

In biopharmaceutical manufacturing, process-related impurities can come from a wide range of raw materials, equipment and other materials that encounter the product during upstream and downstream operations. Because these impurities can be potentially impact product quality and patient safety, removal of these impurities during the purification process becomes critical and thus, detection and quantification of known impurities becomes one of the key Quality Control release measures for both drug substance and drug product.

The WuXi Biologics Center of Excellence for Process Related Impurity Detection utilizes state-of-the-art instrumentation and provides the expertise to develop custom methods and we also provide a comprehensive range of pre-existing assays to detect common process-related impurities. Our team of experts and highly-trained assay development and QC scientists have supported over 150 CMC projects currently in clinical trials and 14 marketed products for a variety of biologics that include polypeptide, monoclonal and bispecific antibodies, fusion proteins, enzymes and other recombinant proteins.



We provide systematic solutions for process-related impurity detection stemming from a wide-range of different sources​​

  • Cell transfection agents and antibiotics or other media additives used in cell line development​
  • Media, resins and other process additives in upstream and downstream unit operations​ ​
  • Chromatography column and membrane materials and storage solvents​
  • Equipment and single-use materials’ particulates

We provide a comprehensive range of assays to detect process-related impurities. Listed below are examples of impurity detection assays previously developed and validated by the WuXi Biologics Process Related Impurity Detection Center of Excellence. This list is not all-inclusive of all assays developed by the Center of Excellence. Contact us to learn more.


#​ Impurity Detection Method​ LOQ​
1​ 2-Fluorotrehalose (2FF)​ UPLC-FLD​ 0.166 μg/mL​
2​ Antifoam C (Simethicone)​ UPLC-ELSD/UPLC-CAD​ 2.0 μg/mL​
3​ Aurein tricarboxylic acid (ATA)​ UPLC-UV​ 0.5 μg/mL​
4​ Benzyl alcohol​ HPLC-UV​ 1.0 ppm​
5​ b-Glucan ​ ELISA​ 3.125pg/ml​
6​ Blasticidin S​ UPLC-UV​ 5.0 ng/mL​
7​ Dextran Sulfate​ UPLC-UV​ 2 μg/mL​
8​ Ethylene Glycol ​ GC-MS​ 2.5 μg/ml​
9​ Ethanol​ GC-MS​ 5ppm(v/v)​
10​ N-Acetylglucosamine (GlcNAc)​ UPLC-FLR​ 0.05 μg/ml​
11​ Guanidine hydrochloride (GnHCl)​ HPLC-UV​ 3.0 μg/ml​
12​ Imidazole ​ UPLC-UV​ 0.1 μg/mL​
13​ Insulin ​ ELISA​ 5.25 mU/L​
14​ Kanamycin​ UPLC-CAD​ 2.0 μg/ml​
15​ LR3 IGF-1​ ELISA​ 3.9ng/ml​
16​ Methionine sulfonate (MSX)​ UPLC-UV​ 0.1 μg/mL​
17​ Methotrexate (MTX) ​ UPLC-UV​ 4.0 ng/mL​
18​ pAF​ HPLC-UV​ 0.025 μg/mL​
19​ pDADMAC ​ UPLC-ELSD​ 3.0 ppm​
20​ PEG 6000​ HPLC-CAD​ 10 μg/ml​
21​ PF68 (Poloxamer)  ​ UPLC-ELSD​ 2.0 μg/mL​
22​ PMSF​ HPLC-UV​ 1.0 μg/ml​
23​ Propylene Glycol​ HPAEC-PAD​ 0.5 μg/mL​
24​ Sodium Caprylate​ UPLC-UV​ 2 μg/mL​
25​ Tri-n-butyl phosphate (TnBP)​ GC-MS​ 0.05ppm(v/v)​
26​ Triton X-100​ HPLC-UV​ 0.125 μg/mL​
27​ Urea​ HPLC-FLD​ 0.5 μg/mL​
28​ Uridine​ HPLC-UV​ 0.6 μg/ml​
29​ Zeocin​ UPLC-UV​ 0.2 μg/mL​

The equipment shown here are examples of our state-of-the-art analytical instrumentation used by the WuXi Biologics Process Related Impurity Detection Center of Excellence. This list is not all-inclusive of all equipment used by the Center of Excellence. Contact us to learn more.


Ion Chromatography System
GC-MS System
Corona Charge Aerosol Detector (CAD)
Evaporative Light Scattering (ELS) Detector​
Quadrupole Dalton (QDa) Detector​

Contact us to learn more about our process-related impurity detection services and our other Centers of Excellence.