SOPs for Biosimilars V 2.0

To define a GMP-compliant procedure for the proper storage of biosimilar purified bulk drug substance (BDS) including labeling, temperature control, documentation, and transfer for further processing or fill-finish operations.
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To establish a validated, GMP-compliant procedure for handling and transferring biosimilar purified bulk drug substance (BDS) under cold-chain conditions to ensure product integrity during internal movement or dispatch to fill-finish facilities.
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To establish a GMP-compliant procedure for cleaning and sterilizing stainless steel or single-use hold vessels used for biosimilar drug substance storage, ensuring microbial and chemical cleanliness prior to use.
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To establish a GMP-compliant procedure for the management, cleaning, inspection, and maintenance of product contact surfaces used in biosimilar manufacturing to ensure product integrity and safety.
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To define the GMP-compliant procedure for filter sterilization of final biosimilar bulk drug substance using validated 0.22 µm filters to ensure microbial safety prior to formulation or fill-finish operations.
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To establish a comprehensive and GMP-compliant procedure for environmental monitoring (EM) during the purification processes in biosimilar manufacturing to detect microbial and particulate contamination in controlled areas.
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To define a systematic and GMP-compliant approach for identifying, documenting, investigating, and resolving deviations observed during downstream processing (DSP) of biosimilar drug substances.
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To establish a standardized procedure for the calibration of chromatography skid systems used in biosimilar downstream processing to ensure all critical sensors and control instruments meet GMP calibration requirements.
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To establish a validated and GMP-compliant procedure for qualifying the performance of chromatography resins used in biosimilar purification processes, including assessment of binding capacity, leakage, pressure-flow characteristics, and resin longevity.
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To define a GMP-compliant procedure for operating, calibrating, and maintaining inline UV absorbance sensors used for monitoring biosimilar protein concentration during chromatography and ultrafiltration processes.
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