Cell Line Development
This technique inserts the gene of interest into host cells.
What is transfection?
This gas is continuously sparged into bioreactors to maintain adequate levels for cellular respiration, typically at 20-40% saturation.
What is oxygen?
This affinity chromatography resin specifically binds to the Fc region of antibodies and is the most common capture step in monoclonal antibody purification.
What is Protein A?
This property describes how easily a protein dissolves in solution.
What is solubility?
This PAT method measures cell metabolism in real-time, utilizing vibrational spectroscopy based on the elastic scattering of monochromatic light.
What is Raman spectroscopy?
This cell sorting technique uses fluorescence to separate and collect individual cells based on their expression levels.
What is FACS (Fluorescence-Activated Cell Sorting)?
This critical parameter, typically maintained between 6.8-7.4 for mammalian cells, affects cell viability and protein folding.
What is pH?
This type of ion exchange chromatography uses negatively charged resin beads to bind positively charged proteins, typically operating at pH values below the protein's isoelectric point.
What is cation exchange chromatography (or CEX)?
This technique freezes drug product to extend shelf life.
What is lyophilization or freeze-drying?
This chromatographic method separates proteins based on their size and is commonly used to detect aggregates and fragments.
What is SEC (Size Exclusion Chromatography)
This process involves isolating and expanding a single cell to create a homogenous population with identical genetic makeup.
What is single cell cloning?
This technique uses small-scale bioreactors to predict large-scale performance.
What is scale-down modeling?
This chromatography mode uses a salt gradient to elute bound proteins from ion exchange resins, with proteins eluting at different salt concentrations based on their charge.
What is gradient elution
Lyophilized, liquid vials, and pre-filled syringes/SC devices are examples of what?
What are commercial formats?
This analytical method uses capillary electrophoresis under reducing conditions to separate and quantify antibody light chains, heavy chains, and any non-glycolsylated heavy chain species.
What is CE-SDS (Capillary Sodium Dodecyl Sulfate) or reduced CE-SDS
This analytical method measures the number of gene copies integrated into a cell’s genome and is critical for cell line characterization.
What is ddPCR (droplet digital Polymerase Chain Reaction) or gene copy number analysis
This feeding strategy involves intermittent addition of concentrated nutrients to extend culture duration and increase productivity.
What is fed-batch?
This measurement describes the amount of target protein that can be loaded onto a chromatography resin before breakthrough occurs, typically expressed in mg/mL resin.
What is binding capacity (or dynamic binding capacity)?
This technique combines the direct imaging capabilities of digital microscopy with the precise control of microfluidics, to get high resolution images, precise counts and sizing with full morphological detail for all sub-visible particles.
What is Micro Flow imaging (MFI)?
This statistical technique is used in PAT to examine multiple measurements or observations simultaneously to look at complex interactions among three or more variables.
What is Multivariate Analysis?
This technology is used to create highly specific genome edits, such as knockouts or knock-ins.
What is CRISPR/Cas9?
This advanced cultivation mode maintains constant culture volume by continuously removing spent medium while adding fresh medium, allowing for steady-state conditions.
What is perfusion?
This automated liquid handling platform uses robotic pipetting and integrated chromatography modules to perform high-throughput screening of purification conditions, enabling rapid evaluation of resin and buffer combinations.
What is the Tecan?
This computational approach predicts protein stability in different formulations.
What is in silico modeling?
This analytical technique uses imaged capillary isoelectric focusing to separate and quantify antibody charge variants with high resolution, providing pI values for acidic, main, and basic species.
What is iCIEF (imaged Capillary Isoelectric Focusing)