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Protein Sciences

Uniting Drug Development Expertise with Antibody & Protein Production Services

Purity & Impurity Testing


Purity & Impurity Testing

Our Protein Sciences (PS) Department offers a variety of analytical methods to evaluate the physiochemical characteristics of proteins as it relates to product purity and the detection of process-related impurities.

 

  • Product-related impurities (including size variants): Evaluated using CE-SDS and size-exclusion chromatography (SEC) with UV and multi-angle light-scattering (MALS) detectors, and other methods.
  • Charge variants: Assessed using ion exchange HPLC (IEX-HPLC) and image-based capillary isoelectric focusing (icIEF).
  • Process-related impurities (host cell protein, host DNA, and other process impurities such as protein A): Routine testing is performed to understand levels of process-related impurities as part of contamination control programs.
  • Microbial control: To help understand microbial control effectiveness, high-throughput testing is conducted to assess endotoxin levels.

Advanced analytical methods for assessing protein identity, structure, and purity, employing CE-SDS, SEC, IEX-HPLC, icIEF, and endotoxin testing.

Protein Characterization Services Details (for Routine Protein Production)

Service Item Description Assay Sample Requirement Test window Request A Quote
Purity/Impurity Test Product related impurities (Size/Charge variant tests) iCIEF 50 ug, >1 mg/ml 1 week Request A Quote
SEC 50-100 ug, >0.5 mg/ml 1 week
SEC-MALS 50ug 1 week
HIC-HPLC 100 ug, >1 mg/ml 1 week
RP-HPLC 20 ug, >1 mg/ml 1 week
NR CE-SDS (Caliper) 10 ul, >0.4 mg/ml 1 week
R CE-SDS (Caliper) 10 ul, >0.4 mg/ml 1 week
Free-thio (Ellman’s assay) 200 ul 1 week

 

Note: For other special needs, please consult with your business development (BD) representative.

Protein Stability Service Details:

Service Item Description Assay Sample Requirement Test window Request A Quote
Purity/Impurity Test Product related impurities (Size/Charge variant tests) iCIEF 50 ug, >1 mg/ml 1 week Request A Quote
SEC 30 ug, >0.5 mg/ml 1 week
HIC-HPLC 50 ug, >1 mg/ml 1 week
RP-HPLC 20 ug, >1 mg/ml 1 week
NR CE-SDS (Caliper) 10 ul, >0.4 mg/ml 1 week
R CE-SDS (Caliper) 10 ul, >0.4 mg/ml 1 week

Note: For other special needs, please consult with your business development (BD) representative.

Your Project. Our Expertise.