Cell Line Development Process
LABORATORY AUTOMATION | DIGITAL SOLUTIONS
Vector Construction
Design sequences and assemble vectors for mAb expression. Confidently screen the created diversity of candidates and select the best hits.
DIGITAL SOLUTIONS
Sequence Verification
Ensure vectors are ligated correctly and that the sequence of interest is intact, readying vectors for the cell line development process.
LABORATORY AUTOMATION | DIGITAL SOLUTIONS
Stable Transfection & Selection
Incorporate vectors into genomes of production cell lines expressing mAb candidates. Gently recover cells and begin maintaining cultures at proper cell densities. Verify that the incorporated insert has not mutated during the transfection and recovery process.
ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Pool Screening
Examine newly raised cell lines for desirable attributes. Screen for product expression, cell viability and division. Automate subsequent verification and selection steps.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Monoclonality Verification
Verifying clones originate from a single cell is critical for regulatory compliance and eliminates product heterogeneity.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Selection Based on Stability/Expansion
Grow and pass cell lines over time. Screen for and document product titer and cell viability after each round. Determine the most favorable media conditions and the hardiest clones. Advance with only the most robust cell lines and highest producers.
DIGITAL SOLUTIONS
Sequence Verification
Verify that the genome inserts have no mutations or modifications compromising therapeutic product activity or quality.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Antibody Characterization
Analyze products for most desirable qualities, such as structure, glycosylation, binding activity and stability.
ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Scale up – Cell Growth/Expansion
Move cultures from small volumes to bioreactors and gather data on how cell lines tolerate bioreactor stresses and volume scaling.
DIGITAL SOLUTIONS
Sequence Verification
Larger culture volumes and cell densities present more opportunities for cultures to evolve. Sequence cell lines after bioreactor scaling and continue if no problematic mutations exist.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
Antibody Characterization
Measure therapeutic product characteristics before transferring cultures downstream, as changes in conditions could affect product expression and translation. Select final candidates for master cell banking and subsequent process development.
LABORATORY AUTOMATION | DIGITAL SOLUTIONS
GMP Master Cell Bank
Preserve stable cell lines to create stocks for transfer to a process development laboratory. Cell banks must be preserved at precise time periods, ensuring quality for later stages of drug development.
