- Quantification Testing: Accurate measurement of biologic content is critical for process consistency and regulatory compliance. Our quantification services include:
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- 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:
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- 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:
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- 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:
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- 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:
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- Bacterial Endotoxin Testing (Kinetic Chromogenic Assay)
- Sterility Testing* and Container Closure Integrity Testing (CCIT)
- Bioburden
*Offered through an approved partner laboratory
At Aragen, we are committed to providing comprehensive Routine Analytical Testing services that meet the scientific, technical, and regulatory demands of biologics development. Our tests are designed to support your biologic through its entire lifecycle, ensuring that your product meets the highest standards of quality, safety, and efficacy.