Master Cell Bank Service Page

Aurigene applies a structured clone evaluation workflow to identify candidates suitable for master cell banking. This stage focuses on selecting clones that combine performance, stability, and product quality consistency.

• Monoclonal screening
• Fed-batch performance evaluation
• Long term stability assessment
• Evaluation in controlled shake-flask fed-batch conditions
• Assessment of productivity, growth characteristics, and expression stability
• Characterization of selected clones for glycan profiles, charge variants, and overall product quality across generations

Once suitable clones are selected, master cell banks are prepared through controlled cryopreservation workflows designed to preserve viability, genetic stability, and traceability. The storage setup supports long term retention and dependable availability of the bank for future development and manufacturing needs.

• Cell bank preparation and characterization
• Controlled cryopreservation workflows
• Secure liquid nitrogen storage for large numbers of cryovials
• Long term preservation and inventory availability for future manufacturing campaigns

The biologics platform is structured to maintain continuity beyond banking, allowing master cell bank programs to connect smoothly with later development and manufacturing stages.

• Integration with upstream development activities
• Continuity from master cell banking to process development
• Support for scale-up and commercial production through integrated R&D and manufacturing facilities

As biologics manufacturing progresses, regulatory expectations often require evaluation of cells at the end of the production lifecycle. End of Production Cells or End of Production Cell Banks represent cells that have been expanded to a passage level comparable to, or exceeding, the maximum in-vitro cell age reached during manufacturing campaigns.

Characterization of these cells helps confirm that the production cell line maintains genetic stability, productivity, and product quality attributes even at late culture stages. This assessment provides additional assurance that the Master Cell Bank–derived production system remains suitable throughout its intended manufacturing lifecycle.

End of Production Cell characterization may include evaluations of cell growth behavior, protein expression performance, genetic stability, and product quality attributes. Together with Master Cell Bank and Working Cell Bank characterization, this stage completes the lifecycle verification of the production cell substrate used in biologics manufacturing.

Master cell bank programs operate within a digital quality environment designed to support traceability, compliance, and reliable operational control throughout the lifecycle of the program.

• Documentation control
• Training management
• Validation tracking
• Change control
• Incident management
• Electronic laboratory notebooks
• Automated data backup
• Controlled access systems
• Structured governance processes supporting data integrity
• Facilities aligned with internationally recognized regulatory and quality standards

• Cell line and clone assessment
• Pool generation and characterization
• Monoclone generation and screening
• Stability assessment of selected clones
• Master cell bank preparation and characterization
• Cryopreservation and long term storage
• End of Production Cell characterization for lifecycle verification of production cell lines
• Integration with upstream process development and manufacturing workflows

Experience with multiple mammalian expression systems and recombinant protein formats enables support for diverse biologics programs.

Large-scale liquid nitrogen storage capacity supports reliable long-term preservation and traceability of cell banks.

Aurigene’s digital infrastructure supports documentation control, data integrity, and regulatory-aligned quality governance.