--- name: Wheeler Bio slug: wheeler-bio site: cdmo website_domain: wheelerbio.com summary: Oklahoma-based CDMO specializing in antibody-based therapeutics from cell line development through cGMP drug substance and drug product manufacturing, featuring the ModularCMC™ platform for phase-appropriate development. Headquartered in Oklahoma City, United States. tagline: High-science, high-touch antibody CDMO from discovery to cGMP manufacturing. founded_year: employee_count_band: employee_count_label: parent_name: parent_slug: hq_country: US tier2_domain_verified: false updated_at: 2026-09-13T11:00:54.582Z services_count: 12 modalities_count: 3 indications_count: 0 locations_count: 1 review_signal_gate: closed generated_by: BioBM Editorial AI --- # Wheeler Bio High-science, high-touch antibody CDMO from discovery to cGMP manufacturing. Listed on cdmo.directory. ## Summary Oklahoma-based CDMO specializing in antibody-based therapeutics from cell line development through cGMP drug substance and drug product manufacturing, featuring the ModularCMC™ platform for phase-appropriate development. Headquartered in Oklahoma City, United States. ## At a glance - HQ country: US ## Services - Cell-Line Development - CMC Analytical Development - Formulation Development - Process Development - Monoclonal Antibody (mAb) Manufacturing - Recombinant Protein Manufacturing - ADC (Antibody-Drug Conjugate) Manufacturing - Sterile Fill-Finish & Aseptic Manufacturing - Stability Testing & Storage - Quality Control Testing - Technology Transfer - CMC Regulatory Submission Support ## Modalities - Biologics (Monoclonal Antibodies) - Antibody-Drug Conjugate (ADC) - Biologics (Other) ## Locations - Headquarters, Oklahoma City, Oklahoma, USA ## Long description ## 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. ## Related companies - [Abzena](/companies/abzena) (Cell-Line Development, CMC Analytical Development) — [Compare](/compare/abzena/wheeler-bio) - [WuXi Biologics](/companies/wuxibiologics) (Cell-Line Development, CMC Analytical Development) — [Compare](/compare/wheeler-bio/wuxibiologics) - [Celonic](/companies/celonic) (Cell-Line Development, CMC Analytical Development) — [Compare](/compare/celonic/wheeler-bio) - [Altruist Biologics](/companies/altruist-biologics) (Cell-Line Development, CMC Analytical Development) — [Compare](/compare/altruist-biologics/wheeler-bio) - [Enzene Biosciences](/companies/enzene) (Cell-Line Development, CMC Analytical Development) — [Compare](/compare/enzene/wheeler-bio) - [Avid Bioservices](/companies/avidbio) (Cell-Line Development, CMC Analytical Development) — [Compare](/compare/avidbio/wheeler-bio) - [Samsung Biologics](/companies/samsungbiologics) (Cell-Line Development, CMC Analytical Development) — [Compare](/compare/samsungbiologics/wheeler-bio) - [KBI Biopharma, Inc.](/companies/kbibiopharma) (Cell-Line Development, CMC Analytical Development) — [Compare](/compare/kbibiopharma/wheeler-bio) _Profile last updated: 2026-09-13T11:00:54.582Z. Profile facts may include AI-assisted enrichment._ Auto-generated by BioBM Editorial AI for machine-readable profile access.