SOPs for Biosimilars V 2.0

To establish a standardized procedure for clarifying harvested cell culture fluid using depth filtration systems prior to downstream purification steps in biosimilar manufacturing under GMP conditions.
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To provide a detailed procedure for the operation of centrifuges for removing cells and cell debris from harvested biosimilar culture fluid prior to downstream processing under Good Manufacturing Practice (GMP) guidelines.
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To define the procedure for installation, use, and integrity testing of pre-filters and sterile-grade filters in biosimilar manufacturing processes to ensure product sterility and compliance with GMP standards.
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To define the GMP-compliant procedure for setting up Protein A affinity chromatography columns used in the capture and purification of monoclonal antibodies in biosimilar manufacturing processes.
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To describe the procedure for equilibrating and loading the Protein A chromatography column used for capture purification of monoclonal antibodies (mAbs) in biosimilar manufacturing under GMP conditions.
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To define the procedure for elution of bound monoclonal antibodies from Protein A affinity chromatography columns and subsequent regeneration of the column for reuse in biosimilar downstream processing.
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To define the procedure for performing viral inactivation through low pH treatment of the product intermediate during biosimilar monoclonal antibody purification, ensuring safety and compliance with regulatory viral clearance expectations.
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To define the procedure for performing buffer exchange of biosimilar monoclonal antibody (mAb) intermediates using tangential flow filtration (TFF) systems to enable downstream purification or formulation compatibility.
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To describe the procedure for performing intermediate purification of biosimilar monoclonal antibodies using ion-exchange chromatography (IEX), ensuring removal of process impurities under GMP-compliant conditions.
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To define the procedure for performing strong cation exchange (SCX) chromatography for intermediate or polishing purification of biosimilar monoclonal antibodies, enabling removal of host cell proteins, aggregates, and charge variants under GMP guidelines.
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