Manufacturing Services

Master Cell Banking

cGMP cell banking services that establish well-characterized production cell banks supporting reliable biologics manufacturing and all phases of cGMP supply.

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Cell Banking Built for Scale-Up

A comprehensive cell banking program that supports the creation, characterization, and storage of development, master, and working cell banks under cGMP conditions.

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cGMP-Grade Cell Banking

Wheeler Bio’s cell banking program covers the generation, characterization, and short-term storage of Development, Master, and Working Cell Banks, designed to serve as the long-term biological foundation for clinical and commercial manufacturing programs. Development Cell Banks are generated during cell line development to bank top-performing clones. Master Cell Banks are manufactured under full cGMP conditions with adventitious agent testing aligned to ICH Q5A and are accompanied by a documentation package suitable for IND, CTA, and BLA submissions. Cell banking activities are designed to meet current regulatory expectations and to live with the program as it advances through clinical development and beyond. 

Biological Continuity

Continuity across each development stage, from the first clone banked to the vials that seed cGMP manufacturing

Built to Scale

Cell banking infrastructure designed to grow with the program, from early clone selection through commercial supply

Regulatory Support

Documentation designed to support IND, CTA, and BLA filing
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Cell Banking Details

Comprehensive cell banking services designed to support development, manufacturing, and regulatory success.

High Touch Project Management

Cell Banking with ModularCMC™

ModularCMC streamlines biologics development through structured, configurable work packages that shorten timelines and support informed decision-making at every stage.

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