Cell bank characterization

Cell bank characterization

  • Identity by PCR and Sequencing (16s and Barcoding)
  • Purity by Sterility, Mycoplasma and Bacteriophage Testing
  • Stability with Sequencing and Copy Number
  • Viral Safety by in-vivo, in-vitro and qPCR
  • Retroviral Detection by RT Assay, TEM and Infectivity
  • Viability and CFU

   

    HАР/MAP Testing

  • Animal Test with the GMP System and FDA
Viral clearance

Viral clearance

  • Viral Clearance and Process Validation
  • Advanced FPLC System for Accurate Protein Separation
  • UV, pH, Conductivity, and Fluorescence Detection
  • Compatible with all Standard & Custom Columns
Mass spectrometry analysis

Mass spectrometry analysis

  • Phosphorylation and Oxidation Analysis
  • N/C Terminal Sequencing
  • Sulfide Band analysis
  • Peptide Mapping
  • N/O Glycan Analysis
  • Intact Mass
  • PTM Analysis
Batch release Testing

Batch release Testing

  • Sterility
  • HCP Service (CHO, E.Coli and Yeast)
  • HCD Service
    • CHO, E.Coli, Yeast, BHK, SF9,
      Sp2/0, CEF, MR5 and Vero
    • R&D service for new hosts
  • BET
    • Quantitative Test (rFC)
    • Qualitative Test (Gel Clot)
physicochemical analysis

Physicochemical analysis

  • PH, Physical Appearance, Osmolality, TOC & Conductivity
  • Residual Analysis with HPLC and Mass
  • Identity by HPLC, ICP
impurities and contaminants

Impurities and contaminants

  • Host Cell Protein (HCP) Analysis
  • Host Cell DNA (HCD) Quantification
  • Residual Protein A Analysis; Process-Related Impurity Testing such as Hentamycin, DMSO and Phenol Red
  • Endotoxin Testing (LAL)
  • Sterility Testing
  • Bioburden Testing
  • Mycoplasma Detection
  • Residual Solvent Analysis
  • Elemental Impurity Testing (ICP-MS)
  • Leachables & Extractables Assessment
  • Adventitious Agent Testing