Wheeler Bio

Overview

Wheeler Bio is a fully integrated Contract Development and Manufacturing Organization (CDMO) headquartered in Oklahoma City, specializing in antibody-based therapeutics. The company supports biologics developers from discovery and cell line development through cGMP Drug Substance and Drug Product manufacturing.

Core Services

ModularCMC™ Platform

Wheeler Bio's proprietary ModularCMC platform delivers phase-appropriate, integrated work packages combining standardized modules, Quality-by-Design principles, and AI/ML-informed process development strategies. The platform enables rapid, data-driven advancement from discovery to cGMP supply while reducing risk through structured evaluation stop points.

CMC Development Services

• Cell Line Development: Mammalian cell line development using ATUM Leap-In Transposon system for stable CHO pool generation, single-cell cloning, selection, and master cell banking
• Process Development & Optimization: Process design and optimization integrated into ModularCMC
• Analytical Development & Qualification: Analytical method development and qualification
• Formulation Development: Drug formulation development services

Manufacturing Services

• Drug Substance Manufacturing: Non-cGMP and cGMP drug substance production at kilogram scale using single-use bioprocessing systems in ballroom suite facilities
• cGMP Technology Transfer: Structured transfer of development process knowledge into cGMP manufacturing environment
• QC Release Testing: Quality control testing and batch disposition with Certificate of Analysis
• Drug Product Manufacturing: Coordination of fill-finish operations through partnerships, container-closure selection, and ICH Q1A(R3)-aligned stability studies

Modality Support

Wheeler Bio supports development and manufacturing of:

• Monoclonal antibodies (mAbs)
• Multispecific antibodies
• Fc-fusion proteins
• Antibody-drug conjugates (ADCs)
• Mammalian-expressed recombinant proteins

Program Types

Flexible program configurations including Lead Selection, Cell Line Development, Rapid Tox Supply, Traditional Tox Supply, and Lead to Clinic programs. Custom combinations available.

Facility & Infrastructure

U.S.-based manufacturing in Oklahoma reduces supply chain risk and supports regulatory alignment. Single-use bioprocessing systems enable accelerated and reliable technology transfer with manufacturing flexibility and rapid campaign changeover.

Philosophy

Wheeler Bio emphasizes a "high-science, high-touch" approach combining deep scientific expertise with accessible project leadership, transparent communication, and dedicated service teams.