The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To define the validated procedure for removing residual host cell DNA during biosimilar purification using chromatography and enzymatic digestion methods to meet regulatory thresholds for DNA content in the final drug substance.
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To establish a validated procedure for reducing endotoxin levels in biosimilar manufacturing using filtration, chromatography, and cleaning controls to ensure product safety and regulatory compliance.
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To define a validated procedure for the removal of aggregates and fragments from biosimilar protein products during downstream processing, ensuring high monomer purity and compliance with regulatory specifications.
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To define a validated GMP procedure for performing viral filtration using 20 nm filters during downstream purification of biosimilar drug substances to ensure effective removal of potential viral contaminants.
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To define a validated procedure for performing integrity testing on viral filtration units using bubble point or gas diffusion methods before and after filtration to confirm filter performance and compliance with GMP standards.
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To define the procedure for the GMP-compliant preparation, filtration, labeling, and storage of buffers used in downstream purification of biosimilar products including chromatography, viral filtration, and final formulation steps.
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To define the standard procedure for collecting in-process samples during the purification of biosimilar products, ensuring aseptic technique, accurate documentation, traceability, and regulatory compliance.
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To define the procedure for validating the maximum allowable hold times for intermediate biosimilar products between downstream processing steps to ensure stability and product quality are maintained during temporary storage.
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To establish a standardized procedure for performing Ultrafiltration/Diafiltration (UF/DF) of biosimilar drug substances for the purposes of concentration adjustment and buffer exchange using validated single-use or stainless steel TFF systems.
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To establish a standardized procedure for the operation of Tangential Flow Filtration (TFF) skids during biosimilar downstream processes, including setup, membrane installation, parameter monitoring, and documentation to comply with GMP guidelines.
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