The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To define a standard procedure for isolating single-cell-derived clones by limiting dilution cloning in order to establish monoclonal cell lines used in biosimilar product development.
Click to read the full article.
To define the standardized method for colony screening and initial expression analysis in transfected cell lines to identify and select high-producing biosimilar clones.
Click to read the full article.
To establish a standardized method for using Enzyme-Linked Immunosorbent Assay (ELISA) to screen biosimilar-producing cell clones based on protein expression levels in the culture supernatant.
Click to read the full article.
To define the standardized procedure for detecting and analyzing biosimilar protein expression in cell lysates using SDS-PAGE followed by Western blotting during clone evaluation and selection.
Click to read the full article.
To establish a standardized procedure for the development of stable mammalian cell lines expressing biosimilar therapeutic proteins. This includes transfection, clone selection, expansion, and characterization steps.
Click to read the full article.
To describe the step-by-step procedure for adapting mammalian cell lines used in biosimilar production from serum-containing media to serum-free media to support regulatory compliance, scalability, and safety.
Click to read the full article.
To establish a standardized method for determining the gene copy number of integrated biosimilar transgenes in cell lines using quantitative PCR (qPCR), aiding in clone selection and stability assessment.
Click to read the full article.
To define the method for performing Southern blot analysis for confirming transgene integration, determining gene copy number, and detecting rearrangements in genetically modified biosimilar-producing cell lines.
Click to read the full article.
To define the standard procedure for analyzing mRNA transcripts of biosimilar genes in transfected cell clones using reverse transcription polymerase chain reaction (RT-PCR).
Click to read the full article.
To define the procedure for evaluating biosimilar protein expression levels in engineered cell clones using SDS-PAGE, Western blotting, and densitometry techniques for clone selection and development decisions.
Click to read the full article.