SOPs for Biosimilars V 2.0

To define the procedure for real-time monitoring and accurate documentation of critical process parameters during biosimilar bioreactor operations, ensuring data integrity and adherence to GMP requirements.
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To define the procedure for identifying, documenting, evaluating, investigating, and resolving deviations that occur during upstream manufacturing runs of biosimilars. This ensures consistent quality, regulatory compliance, and traceability.
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To define the procedure for accurate, timely, and compliant entry of manufacturing process data into the Electronic Batch Record (EBR) system during upstream biosimilar production, in alignment with data integrity and GMP principles.
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To establish a procedure for the collection, archival, retrieval, and review of raw data generated during upstream biosimilar production activities, ensuring compliance with regulatory requirements and internal policies on data integrity.
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To define the protocol for controlled oxygen enrichment in bioreactor systems used for biosimilar production to maintain optimal dissolved oxygen (DO) levels required for healthy cell growth and viability.
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To define the procedure for carbon dioxide (CO₂) sparging in bioreactor systems during biosimilar upstream processes, primarily for pH control and maintaining an optimal environment for cell culture growth.
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To define the procedure for validation of the seed train process used in upstream biosimilar production, ensuring consistency of cell growth and quality attributes from thaw to production-scale inoculum.
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To outline the aseptic techniques and procedural steps required during inoculation of seed cultures into production bioreactors in biosimilar upstream processes, thereby minimizing the risk of contamination.
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To define the procedure for aseptic and controlled transfer of cell culture from one tank to another (e.g., seed to seed, or seed to production bioreactor) during upstream biosimilar manufacturing, ensuring sterility and product integrity.
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To define the procedure for aseptic, accurate, and timely sampling during night shifts from upstream bioreactor systems in biosimilar manufacturing, ensuring sample integrity and traceability.
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