SOPs for Biosimilars V 2.0

To establish a standard procedure for conducting strong anion exchange (AEX) chromatography for intermediate purification or polishing of biosimilar proteins by removing process-related impurities, host cell DNA, and viral particles.
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To establish a standard procedure for the optimization of salt gradients in ion-exchange chromatography (IEX) for biosimilar purification, enabling effective separation of product, variants, and impurities under GMP-compliant conditions.
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To define the standard procedure for performing Hydrophobic Interaction Chromatography (HIC) for purification and polishing of biosimilar monoclonal antibodies or recombinant proteins under GMP-compliant conditions.
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To define the procedure for performing polishing purification of biosimilar products using size exclusion chromatography (SEC) to remove aggregates and achieve final product purity under GMP conditions.
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To describe the procedure for packing and unpacking chromatography columns used in biosimilar purification under GMP conditions, ensuring column efficiency, reproducibility, and resin integrity.
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To define the procedure for sanitizing chromatography columns used in the purification of biosimilar proteins to prevent microbial contamination, ensure resin longevity, and maintain GMP compliance.
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To define the procedure for managing the complete life cycle of chromatography resins used in biosimilar manufacturing, including usage tracking, regeneration, performance monitoring, and safe disposal to ensure GMP compliance and consistent product quality.
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To define the procedure for validated cleaning-in-place (CIP) of chromatography skids used in biosimilar manufacturing, ensuring effective residue removal and equipment readiness for subsequent purification campaigns under GMP.
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To define the procedure for the regeneration and storage of chromatography resins used in biosimilar manufacturing to maintain resin performance, prevent microbial growth, and ensure compliance with GMP guidelines.
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To outline the procedure for effective removal of host cell proteins (HCP) during the downstream processing of biosimilars using validated purification steps to ensure product purity and compliance with GMP requirements.
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