Process- and Product-Related Impurities

In the course of product manufacturing, a number of chemicals are typically added upstream to improve on product expression, recovery, etc. These chemicals are almost entirely removed during the downstream purification process; however, residual levels of these agents may be left within the bulk drug substance and drug product. To ensure that the residual level of these agents is within safe amounts, highly sensitive analytical methods have been developed to detect and quantify such residuals. Charles River offers a full spectrum of ready-to-use analytical methods for the detection and quantification of process- and product-related residuals and impurities.

  • IPTG (isopropylthio-beta-D-galactoside)
  • PEI (polyethylenimine)
  • Kanamycin
  • Antifoam
  • TFA/Acetate
  • Cyanate
  • Triton X-100
  • Polysorbate (Tween) 20/80
  • Zwittergent
  • Pluronic
  • Protein A
  • PEG
  • TRIS
  • Growth Factors
  • CHO/E. coli HCP
  • N-Terminal Truncations
  • Oxidation/Deamidation (PTMs)
  • Disulfide Bridge Scrambling (misfolding)
  • C-Terminal Integrity/Multiple Lysines
  • Aggregation

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