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To define a standardized procedure for adjusting the protein concentration of biosimilar bulk drug substances after ultrafiltration (UF) to meet final specification prior to bulk storage or formulation.
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To provide a controlled procedure for the adjustment of pH in bulk biosimilar protein solutions after purification, ensuring product quality, stability, and compliance with GMP standards.
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To define the procedure for the selection, inspection, assembly, use, and disposal of single-use systems (SUS) in downstream processing (DSP) operations of biosimilar products in accordance with GMP standards.
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To establish a validated procedure for protein refolding of biosimilar drug substances expressed in bacterial systems as inclusion bodies, allowing recovery of biologically active conformation under GMP conditions.
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To describe the procedure for performing controlled reduction and alkylation of biosimilar protein samples, typically for characterization or prior to protein refolding, ensuring consistent disulfide bond modification under GMP.
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To establish a GMP-compliant procedure for the solubilization of inclusion bodies (IBs) expressed in E. coli during biosimilar protein production, enabling downstream purification or refolding.
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To define a validated and GMP-compliant procedure for the effective removal of bacterial endotoxins (lipopolysaccharides, LPS) from biosimilar proteins expressed in E. coli to ensure product safety and regulatory compliance.
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To describe a GMP-compliant procedure for executing precipitation and clarification steps in biosimilar manufacturing for the removal of impurities or concentration of the target protein prior to downstream purification.
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To establish a standard procedure for reviewing and analyzing chromatograms obtained from biosimilar purification processes and quality control testing, ensuring accurate interpretation and GMP-compliant data reporting.
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To define a standardized and GMP-compliant procedure for collecting, handling, and documenting samples for process validation during downstream processing (DSP) of biosimilars.
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