The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To describe the procedure for monitoring and adjusting agitation and aeration parameters in bioreactor systems to ensure proper mixing, oxygen transfer, and cell viability during biosimilar production.
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To establish a procedure for the selection, preparation, and controlled addition of antifoam agents to bioreactors during biosimilar upstream processing in order to prevent or mitigate foam generation without impacting product quality.
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To establish a procedure for calibrating foam sensors installed in bioreactor systems used during upstream biosimilar production, ensuring accurate foam detection and triggering of automated antifoam addition or alarms.
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To define the process for executing fed-batch cultivation in bioreactor operations for biosimilar production, ensuring consistent cell growth, product yield, and regulatory compliance under GMP conditions.
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To define the procedure for implementing and managing perfusion culture techniques in bioreactor operations for biosimilar production, ensuring high-density cell growth and continuous product harvest under GMP compliance.
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To define the standardized procedure for the preparation, filtration, labeling, storage, and controlled aseptic addition of nutrient feeds into bioreactors during biosimilar upstream processing.
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To define the procedure for configuring, verifying, and managing Dissolved Oxygen (DO) cascade settings in bioreactor operations to ensure optimal cell growth conditions during biosimilar manufacturing.
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To define the standardized method for aseptic in-process sampling from bioreactors used in biosimilar production. This SOP ensures representative, contaminant-free samples for analysis of critical process parameters.
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To establish a standard method for detecting microbial contamination during bioreactor operations in the biosimilar manufacturing process, ensuring timely identification and mitigation in compliance with GMP guidelines.
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To define the standardized procedure for monitoring cell density in bioreactor operations using Viable Cell Density (VCD) via hemocytometer/automated counter and Optical Density (OD600) using a spectrophotometer during biosimilar production.
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