Cell Line Development
Creating a Reliable Cell Line
The success of any biologic drug (both biosimilars and innovative biologics) begins with a stable and high-performing production cell line. Outsourcing CLD to an experienced biologics partner allows biotech companies to reduce technical risk, shorten development timelines, and avoid costly late-stage process failures.
Most biologics manufacturing programs today rely on mammalian and insect expression systems because of their proven regulatory track record, adaptability to suspension cultures, and ability to generate therapeutic proteins with appropriate glycosylation profiles and biological activity. Mabion has extensive experience working with multiple CHO cell line platforms commonly used in commercial biologics manufacturing, enabling development strategies optimized for productivity, stability, and scalability requirements. Our teams support programs involving monoclonal antibodies, recombinant proteins, bispecific antibodies, and other complex biologic formats.
The Beacon Select™ System represents the gold standard in modern Cell Line Development and forms the technological core of Mabion’s CLD platform. Beacon isolates and tracks individual cells while continuously documenting clonal origin through automated imaging. This approach enables rapid confirmation of 100% monoclonality aligned with FDA and EMA expectations while simultaneously performing real-time functional and quality assays directly on the selected clones. Compared with traditional plate-based methods, Beacon significantly shortens CLD timelines.
Personalize your Cell Line Development Process
As a standalone service, we also offer the design of a cell line development strategy from scratch, according to the following framework:
- Project kickoff and assessment of the target molecule, and desired product quality attributes
- Selection of the optimal mammalian or insect host cell platform, primarily CHO-based systems
- Transfection of host cells by recombinant DNA constructs using optimized delivery methods under tightly controlled culture conditions
- Application of selective pressure to enrich successfully transfected cells with stable gene integration
- Automated single-cell isolation using the Beacon Select™ System
- Continuous image-based monitoring of single-cell growth to provide documented proof of monoclonality
- High-throughput screening of thousands of clones in parallel for productivity, growth kinetics, secretion performance, and stability
- Early characterization of critical quality attributes, including glycosylation patterns, aggregation tendency, and product quality profiles
- Ranking and selection of the highest-performing clones based on multiparametric analytical data
- Expansion of selected clones in suspension cultures and scale-down bioprocess models
- Verification of long-term genetic stability, productivity consistency, and manufacturing robustness across multiple passages
- Cell Banking: Generation of research and GMP-compliant Master Cell Banks (MCB) and Working Cell Banks (WCB)
- Comprehensive analytical characterization, sterility testing, and documentation aligned with regulatory expectations
- Seamless transfer of selected production clones into process development workflows within Mabion’s integrated biologics platform.
For clients, this translates into faster progression toward GMP Drug Substance Manufacturing, lower risk, improved regulatory readiness, and higher confidence in long-term process stability.