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What we do Biologics Analytical Services Routine Analytical Testing

Routine Analytical Testing

Ensuring Consistency and Quality with Rigorous Testing 

Routine testing is essential for confirming the quality, safety, and efficacy of biologic products throughout the development and manufacturing lifecycle. At Aragen, we recognize the significance of thorough and precise analytical testing in the development lifecycle of a biologics. Our Routine Analytical Testing services are designed to meet the ongoing needs of biologics manufacturing, ensuring product quality, consistency, and regulatory compliance. These services are designed to deliver reliable, scientifically robust data to support in-process monitoring, batch release, and stability studies.

  • Quantification Testing: Accurate measurement of biologic content is critical for process consistency and regulatory compliance. Our quantification services include:
    • Spent Media Analysis by LC-MS 
    • IgG Titer Estimation (Affinity Chromatography)
    • Protein Concentration by Fixed pathlength (UV Spectrophotometer) & Variable pathlength (Stunner)
    • Sialic Acid Estimation (Reversed-Phase Chromatography)
    • Polysorbate Estimation (Reversed-Phase Chromatography)
    • Estimation of Sugars (Reversed-Phase Chromatography)
  • Purity & Impurity Testing: Ensuring the purity of biologics is crucial to meet regulatory guidelines and ensure patient safety. Our tests include:
    • HMW Aggregates by Size-Exclusion Chromatography 
    • LMW Fragments by Capillary Electrophoresis  
    • Non-Glycosylated Heavy Chain by Capillary Electrophoresis 
  • Identity Testing: Accurate identity testing confirms that the biologic product matches the intended molecule and is free from contaminants. Our identity testing includes:
    • Peptide Mapping by RP-LC 
    • Capillary Iso-Electric Focusing (cIEF) 
    • SDS-PAGE
  • Charge Heterogeneity Testing: Charge variants can significantly impact the behaviour of biological molecules. We assess charge heterogeneity by Ion Exchange Chromatography (IEC).
  • Glycan Profile: Oligonucleotides have direct impact on protein stability, bioactivity, and immunogenicity; hence it is mandatory to monitor at the time of batch release by Hydrophilic Interaction Chromatography (HILIC).
  • Process-Related Impurities: Identifying and quantifying impurities originating from the manufacturing process is critical for biologic safety. We perform testing for:
    • Host Cell Proteins (ELISA)
    • Protein-A Leachate (ELISA)
    • Host Cell DNA (RT-PCR)
  • Safety Testing: Ensuring biologics are safe for clinical use is paramount. We offer a suite of safety testing services, including:
    • Bacterial Endotoxin Testing (Kinetic Chromogenic Assay)
    • Sterility Testing* and Container Closure Integrity Testing (CCIT)
    • Bioburden

*Offered through an approved partner laboratory

Aragen’s routine analytical testing services support in-process monitoring, batch release, stability studies and product quality assessment for biologics development and manufacturing programmes.

Learn more about our end-
to-end capabilities

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