High science development
Cell Line Development Through ModularCMC™
ModularCMC™ streamlines biologics development through structured, configurable work packages that shorten timelines and support informed decision-making at every stage.
CMC Development Services
Cell Line Development
The cell line is the biological foundation of every program, and the decisions made during cell line development determine the success of all subsequent phases of therapeutic development and manufacturing.
Cell Banks Built for Scale-Up
Wheeler Bio’s cell line development program is built on transposon-mediated stable gene integration and elite, performance-optimized CHO host cell lines. Transposon-based integration delivers stable, high-level transgene expression by directing insertion to transcriptionally active regions of the genome, an approach designed to produce stable CHO pools with consistent product quality profiles and high productivity.
Molecule-Specific Strategies
Wheeler Bio’s approach applies AI/ML-informed clone selection and ICH Q5D-aligned stability studies to identify a high-performing, productive clone for cGMP Master Cell Bank development designed to carry programs from first-in-human through commercialization. The criteria applied to clone selection are designed around the molecule: titer, growth, and product quality, with special attention to assembly efficiency alongside productivity for multispecific and Fc-fusion programs.
Built for Scale-up
Cell line development built on a production-grade CHO platformAI/ML Clone Selection
AI/ML-informed clone ranking, compressing the path from pool to selected cloneGMP Master Cell Bank
cGMP Master Cell Bank that anchors the program from start to finish
Expression to Cell Bank
From clone selection through cell banking, development activities are designed to prioritize manufacturability, product quality, and program continuity as candidates advance through cGMP manufacturing.
Designed to deliver high-level, stable transgene expression at transcriptionally active genomic sites, producing stable CHO pools with consistent productivity and product quality
Stable pool generation evaluated for productivity and key product quality attributes to support lead pool selection, bioreactor performance, and lead development candidate nomination, if needed
Ranking of clones by titer, growth kinetics, and product quality
Top-performing clones assessed in a production-relevant system for productivity, growth, and format-appropriate quality attributes, including assembly efficiency for multispecific and Fc-fusion programs
cGMP facility with assessment of bank recovery from thaw, adventitious agent testing per ICH Q5A; Certificate of Analysis and documentation preparation for IND/CTA submissions
ICH Q5D-aligned assessment across ≥60 generations
Get in Touch
A Partnership for Biologics Manufacturing Success
Ready to scale-up your antibody-based therapeutic? Contact us to learn how ModularCMC™ derisks the path to patients.