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 through cGMP manufacturing, with a focus on monoclonal antibodies, multispecific antibodies, Fc-fusion proteins, and antibody-drug conjugates (ADCs).

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: Structured process design and optimization
• Analytical Development & Qualification: Method development and qualification
• Formulation Development: Drug product formulation support

Manufacturing Services

• Drug Substance Manufacturing: Non-cGMP and cGMP production of monoclonal antibodies, multispecific antibodies, Fc-fusion proteins, and mammalian-expressed recombinant proteins at kilogram-scale quantities
• cGMP Technology Transfer: Structured transfer of development process knowledge into cGMP manufacturing environment, including process risk assessment, bill of materials generation, raw material specification development, and master batch record preparation
• Drug Product Manufacturing: cGMP drug substance release through fill-finish coordination, drug product release testing, and ICH Q1A(R3)-aligned stability studies
• Fill-Finish Services: Conducted through partnership arrangements with seamless high-touch project management

Partnered Services

• Lead optimization
• Regulatory support (in partnership with Pharmefex)
• Fill-finish operations

Manufacturing Infrastructure

Wheeler Bio's facility is designed for flexible and efficient cGMP manufacturing utilizing single-use bioprocessing systems in ballroom suites, enabling accelerated and reliable technology transfer. The facility supports kilogram-scale drug substance production with quality oversight embedded at every stage from raw material release to batch disposition and Certificate of Analysis (CoA) generation.

Program Types

The company offers five primary program types combining modular work packages:

1. Lead Selection
2. Cell Line Development
3. Rapid Tox Supply
4. Traditional Tox Supply
5. Lead to Clinic and Beyond

Custom program combinations are available to match specific development scopes.

Differentiation

Wheeler Bio emphasizes a "high-science, high-touch" philosophy integrating deep scientific expertise with accessible project leadership, timely communication, and transparent collaboration. U.S.-based manufacturing in Oklahoma reduces supply chain exposure and supports regulatory alignment.