SOPs for Biosimilars V 2.0

To establish a standardized procedure for selecting host cell lines such as CHO, HEK293, and E. coli for the development of biosimilars, ensuring high productivity, regulatory compliance, and reproducibility.
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To describe the standardized procedure for gene synthesis and verification of nucleotide sequences to ensure fidelity and regulatory compliance in biosimilar product development.
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To describe the procedure for designing plasmid expression vectors and performing gene cloning required for biosimilar development, ensuring proper integration, regulatory compliance, and traceability of constructs.
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To define the process for preparing chemically and electrocompetent E. coli cells for use in transformation procedures during biosimilar molecular biology workflows.
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To outline the standardized procedure for introducing recombinant plasmids into host cells using chemical transformation and electroporation methods in biosimilar development workflows.
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To define the process for amplifying and purifying plasmid DNA from transformed bacterial cells to ensure high-quality DNA yield suitable for downstream biosimilar applications.
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To establish a standard method for performing restriction enzyme digestion and mapping of plasmid DNA for verification of insert orientation, integration, and overall vector integrity during biosimilar development.
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To establish a standardized procedure for performing agarose gel electrophoresis to separate, identify, and analyze DNA fragments for plasmid confirmation and molecular biology workflows in biosimilar development.
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To define the procedure for transient transfection of mammalian cells using lipid-mediated or electroporation techniques for the expression of biosimilar proteins in early-stage R&D experiments.
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To define the process for selecting, isolating, and expanding stably transfected mammalian cell clones that integrate the gene of interest for long-term expression of biosimilar proteins.
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