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To define the standard procedure for preparation of seed culture from cryopreserved cell banks for initiation of biosimilar upstream fermentation processes in GMP-controlled environments.
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To define the procedure for accurate preparation, sterilization, and storage of culture media used in upstream biosimilar fermentation processes to ensure product quality, batch consistency, and GMP compliance.
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To define the standardized procedure for selection, preparation, and use of chemically defined media (CDM) in upstream biosimilar manufacturing to ensure reproducibility, animal component-free operations, and alignment with regulatory expectations.
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To establish a standardized procedure for assembly, cleaning, and sterilization of bioreactor vessels used in the upstream processing of biosimilars, ensuring aseptic operations and regulatory compliance.
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To outline the procedure for aseptic inoculation of shake flasks in biosimilar upstream processing to ensure optimal cell growth and contamination-free seed train scale-up.
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To define the procedure for aseptic scale-up of seed cultures from shake flasks to spinner flasks as part of the biosimilar upstream process, maintaining cell viability, sterility, and traceability in accordance with GMP.
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To establish a standardized procedure for inoculating bioreactors under aseptic conditions with qualified seed culture in biosimilar manufacturing, ensuring culture viability and contamination control.
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To define the procedure for controlling, monitoring, and documenting temperature parameters in bioreactors used for upstream biosimilar manufacturing to ensure optimal cell culture conditions and regulatory compliance.
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To provide a standardized procedure for monitoring and adjusting pH in bioreactors during biosimilar manufacturing processes, ensuring optimal cell growth conditions and GMP compliance.
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To define the procedure for maintaining and controlling dissolved oxygen (DO) levels in bioreactor systems used in upstream biosimilar production, ensuring optimal cell growth and productivity under GMP conditions.
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