Production Methods

Production Methods

28/05/2025

Production Methods: AAROGYAM uses biomanufacturing to enable the cost-effective generation of Anti-CTLA-4. Key methods include: Cell Culture and Fermentation: Using genetically engineered cell lines to produce Anti-CTLA-4 proteins. Purification & Chromatography – Pure Extraction by Column Chromatography and ultra filtration. Sterile Filtration & Aseptic Processing – Preserving biological efficacy for therapeutic use.

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Quality Testing

Quality Testing

28/05/2025

Quality Testing Approaches For safety, efficacy and regulatory purposes AAROGYAM implements stringent Quality Assurance (QA) and Quality Control (QC) measures: Batch Control & Stability Testing – Ensuring uniformity and long-term stability of Anti-CTLA-4 formulations. Fluorescence-Based Assays - measurement of binding capability and molecular interactions. Regulatory Compliance & Risk Management – Compliance settings to align with pharmaceutical quality ICH guidelines.

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Laboratory plan

Laboratory plan

28/05/2025

Laboratory Plan AAROGYAM's biotech research laboratory Designed for efficiency and safety, ease of use, and scale: Cell Culture, Purification, Analytical Testing Dedicated Zones -Independent zones for cell culture, purification, and analytical Testing. Sophisticated Apparatuses – Devices such as bioreactors, chromatography systems, and fluorescence analyzers. Safety & Compliance – Biosafety protocols, Waste management and adherence to regulations

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