Advancing Discovery

A paradigm shift in the translation to GMP manufacturing.  We are raising the bar in biologics development services.

  • Best-in class mammalian cell line development
  • Automated process & analytical development
  • GLP material supply
  • Efficient path to GMP

Learn More

About Us

A New Path

Paradigm shift in the path from
discovery to GMP manufacturing.
For Innovators, Portable CMC™
moves the development workflow
further upstream and reduces
manufacturing risks in parallel
with drug discovery.

Built for Speed

Portable CMC™ delivers speed,
efficiency, predictability, and
freedom. Portable CMC™ will
standardize, commoditize and
democratize the development
to manufacturing process.

Win Together

Open-source development
platform integrated with CRO
discovery. The concept is open
source, so innovators are not
locked in, and can go to any
manufacturer of their choice much more easily.

Our Capabilities

Boston R&D Center ~ Protein Sciences Focus

Alloy Therapeutics’ Boston-based research facility is the site of Wheeler Bio’s new R&D Center. With its innovation mandate squarely fixed on protein sciences, the Boston-based Wheeler Bio team is developing enabling tools and processes centered on expression vectors, transient and stable pool based protein production, advanced cell line engineering, and preclinical material generation from stable pools (milligrams and grams). Co-location of Wheeler’s R&D Center inside a discovery partner like Alloy Therapeutics allows unfettered collaboration among scientists at partnering organizations for the direct benefit of CRO customers.  

Vector Design and Protein Engineering

With our Boston-based team of molecular biologists, we now specialize in “vectorology” i.e., a one-stop-shop for the design, construction and validation of recombinant protein expression vectors. Working closely with customers to develop bespoke, success-based design plans, we leverage our in-house in silico and bench expertise for hands-on execution. We perform vector validations using our HEK or CHO transient expression systems coupled with extensive protein analytics.  

Capabilities:

  • Custom vector design, construction and validation
  • Codon optimization for enhanced host cell line expression
  • Protein engineering (fusions, tags, half-life extension) for functional and characterization purposes
  • Targeted mutagenesis of protein-of-interest
  • Aligning expression technologies with CMC and manufacturability

Transient Expression (Expi293 & ExpiCHO)

A redundant capability with our Oklahoma City based operations, we offer flexible protein expression services and continually work to improve our enabling tools. Our CHO-based transient expression system, delivering milligram to gram quantities of recombinant proteins from a CMC-relevant genetic background, often marks the first time that customers migrate to CHO in the discovery workflow — and away from HEK293 or some other transient expression system. We use transient expression in CHO to rapidly screen molecular formats of the target protein, with the data being cycled back for further vector engineering to improve the final outcome. 

Capabilities:

  • Access to a dedicated protein sciences team with over 50 years of combined protein expression expertise
  • Access to proven, high-titer transient expression systems (ExpiCHO and Expi293) 
  • Use of highly automated transfection, outgrowth and transient pool generation workflow
  • Compatibility with a full spectrum of therapeutic proteins including single-peptide ORFs, mAbs, Fabs, Fc fusions, cytokine fusions, bispecific, etc.
  • 0.5-5L shake-flask production (milligram quantities)
  • 5-50L single-use bioreactor capacity (gram quantities)
  • One-column affinity capture purification with ÄKTA protein purification system
  • Second column polishing (optional)
  • Buffer exchange into customer defined buffer or PBS
  • Aliquot generation

Advanced Cell Line Engineering

We offer advanced cell line engineering, through a partnership with an industry-leader in the field of genome engineering, to offer customers the option of modifying Wheeler’s own proprietary CHO-K1 cell line, ECHO2. The cell line engineering is highly efficient and specific, leading to fast turn-around times with high genetic fidelity enabling the customer to obtain the ideal genetic background for the development of their therapeutic candidate.

OKC Development Center ~ Process Development Focus

We have a world-class development team dedicated to mammalian bioprocess design, development, characterization and intensification. Our leadership team has worked on hundreds of drug substance processes over the last two decades spanning a wide range of process modalities such as fed-batch, perfusion, microcarriers, and fiber-cell disks and a wide range of product types such as mAbs, bsAbs, fabs, scFvs, enzymes, vaccines, fusion proteins, cytokines, plasmids and CGTx. Whether beginning from ground level or optimizing a current process or using Wheeler’s platform for mAbs (Portable CMC™), our expert process development scientists can deliver a cost-effective scalable method for drug substance preparation

Wheeler offers flexible protein expression services and continually works to improve our enabling tools.   Our CHO-based transient expression system, delivering milligram to gram quantities of recombinant proteins from a CMC-relevant genetic background, often marks the first time that customers migrate to CHO in the discovery workflow — and away from HEK293 or some other transient expression system.   We use transient expression in CHO to rapidly screen molecular formats of the target protein, with the data being cycled back for further vector engineering (in our Boston R&D Center) to improve the final outcome. 

Transient Expression

Capabilities:

  • Access to dedicated service team with over 50 years of combined protein expression expertise
  • Access to state-of-the-art protein analytical lab
  • Access to proven, high-titer transient expression systems (ExpiCHO and Expi293) 
  • Highly automated transfection, outgrowth and transient pool generation workflow
  • Compatibility with a full spectrum of therapeutic proteins including single-peptide ORFS, mAbs, Fabs, Fc fusions, cytokine fusions, bispecifics, etc.
  • 0.5-5L shake-flask production (milligram quantities)
  • 5-50L single-use bioreactor capacity (gram quantities)
  • One-column affinity capture purification with ÄKTA protein purification system
  • Second column polishing (optional)
  • Buffer exchange into customer defined buffer or PBS
  • Aliquot generation
  • Final certificate of analysis (CoA)

Portable CMC™ Clone Selection (Cell Line Development)

Robust, consistent, agency-vetted cell lines are foundational to Wheeler’s cell line development (CLD) service called Portable CMC™ Clone Selection. Our CLD team members are seasoned practitioners of industry proven CHOSOURCE™ cell line from Horizon™ (Perkin Elmer) and companion transposon tool for high-fidelity, transposon-based gene delivery. Distinguished by cutting-edge genetic tools that are amenable to the expression of many classes of proteins including hard-to-express variants, what also makes our CLD service truly unique is its seamless integration with Wheeler’s non-exclusive method for the scalable preparation of mAbs (Portable CMC™ CDMO Selection). This inherent connection between cell substrate and drug substance process gives customers assurance that their final clone will be manufacturable and accepted by the FDA.

Capabilities:

  • Access to dedicated service team with over 50 years of combined CLD expertise
  • Access to proven, high-titer compatible CHO-K1 parental cell line with extensive regulatory track record
  • Access to optimized Wheeler vector backbones with transposon based gene delivery tool  
  • Highly automated transfection, outgrowth and pool generation workflow
  • Efficient, consistent, and verifiable clone isolation
  • Ambr® 15 based clone screening
  • Genetic stability assessment of clones (60-generations)
  • Ambr® 250 based manufacturability assessment (optional)
  • Cell line development report that includes vector sequences, host banking information (not product specific), cloning traceability and documentation of clonality 

Process Development

We have a world-class development team dedicated to mammalian bioprocess design, development, characterization and intensification. Our leadership team has worked on hundreds of drug substance processes over the last two decades spanning a wide range of process modalities such as fed-batch, perfusion, microcarriers, and fiber-cell disks and a wide range of product types such as mAbs, bsAbs, fabs, scFvs, enzymes, vaccines, fusion proteins, cytokines, plasmids and CGTx. Whether beginning from ground level or optimizing a current process or using Wheeler’s platform for mAbs (Portable CMC™), our expert process development scientists can deliver a cost-effective scalable method for drug substance preparation. 

Capabilities:

  • Basal and feed media screening and optimization
  • Fed-batch or perfusion process intensification
  • Chromatographic unit operation process development
  • Filter unit operation process development 
  • Process characterization and compatibility studies
  • Liquid or lyophilized formulation development

Analytical Development

Our  wide range of analytical development capabilities support your product process development activities on a continuous basis. Robust measurement systems underlie a modern QbD approach to ensure that methods for preparation of drug substance meet your requirements for safety, integrity, strength, purity, and quality (SISPQ). Our capabilities include:

Capabilities:

  • Release method development
  • In-process control (IPC) method development
  • Molecular and cellular bioassay and complement binding assay development
  • Critical quality attributes (CQAs) design for glycosylation, oxidation, aggregates, activity, concentration
  • Fed-batch validation, testing, lot release methods
  • Perfusion analytical methods for in-process testing
  • Analytical section for IND/BLA dossier preparation

Preclinical Material Supply & Testing

Our approach to preclinical material preparation leverages scaled-down models that are proven to meet prospective CQAs. Scaled-down model evaluations provide both data and materials for preclinical testing.  Our Oklahoma City Development Center features a 3,000 sq. ft. GLP-compliant protein sciences lab that gives our customers access to a scaled-down, standard method for the preparation and analysis of presumptive drug substances deriving from stable pools or clones. Our preclinical material supply services in Oklahoma City include:

Capabilities:

  • Shake flask based seed expansion
  • Small scale manufacturing for drug feasibility studies, process and method development, and early R&D material requirements
  • Non-GMP production for process scalability and robustness evaluation
  • IND-enabling toxicology study material generation
  • Genetic and mammalian toxicology testing, using non-GLP assays for discovery, development and screening, and GLP assays for regulatory submissions

Wheeler Bio Tours & Technology

Boston R&D Center Lab Equipment:

Molecular Biology

  • Smart2Pure UV/UF Water System
  • Gen Scanner (Bio-Rad)
  • SDS-PAGE System (Bio-Rad)
  • Mini Gel System (Thermo Scientific™)
  • Platform Rocker (Thermo Scientific™)
  • Vortex Mixers
  • CFX384 Touch™ Real-Time PCR Detection System (Bio-Rad)

Protein Expression Systems

  • CHOSOURCE™ Expression Platform (Horizon™/Perkin Elmer) (Royalty-free)
  • ExpiCHO Expression System (Gibco/Thermo)
  • Expi293 Expression System (Gibco/Thermo)
  • ECHO2™ Expression Platform (Wheeler Bio, Beta Version Only) (Royalty-free, License-free)

Solentim Cell Line Development Ecosystem

  • Cell Metric® high contrast whole-well imager

Cell Sorting and Transfection Technologies

  • Neon™ Transfection System (Invitrogen)

High Throughput Processing, Data Management, and Automation

  • Eppendorf® New Brunswick™ BioFlo 320 (10cc – 50cc BioBLU vessels)
  • ReadyToProcess WAVE 25 (Cytiva)
  • ÄKTA pure(Cytiva)
  • PureTec® Automated TFF (SciLog)
  • Life Sciences R&D Cloud (Synthace)
  • Process Data Analytics Software (DataHow)

Process and Protein Analytics

  • Vi-Cell™ XR Cell Viability Analyzer (Beckman Coulter)
  • BioProfile® FLEX2 (Nova Biomedical)
  • Vanquish™ HPLC/UHPLC (Thermo Scientific™)
  • Nanodrop (Thermo Scientific™)

Incubators, Cold Chain, and Environmental Controls

  • Eppendorf® New Brunswick™ S41i CO2 Incubator Shakers (one dedicated per customer)
  • BD260 Standard Incubator (260 L)
  • 6’ and 4’ Biosafety Cabinets (Nuaire)
  • 2-8ºC (Thermo Scientific)
  • -20ºC (Thermo Scientific)
  • -80ºC (Thermo Scientific)
  • Liquid Nitrogen Storage (Custom Biogenics)
  • AC600 Series Systems PCR Workstation
  • TRACEABLELIVE™ Temp Data Logger (Grainger)

Microscopy and Imaging

  • Echo Revolve 4 (RVL-110-m) Upright and Inverted
  • Cell Metric® high contrast whole-well imager (2nd system, Solentim)

Oklahoma City Development Lab Equipment:

Protein Expression Systems

  • CHOSOURCE™ Expression Platform (Horizon™/Perkin Elmer) (Royalty-free)
  • ExpiCHO Expression System (Gibco/Thermo)
  • Expi293 Expression System (Gibco/Thermo)
  • ECHO2™ Expression Platform (Wheeler Bio, Beta Version Only) (Royalty-free, License-free)

Solentim Cell Line Development Ecosystem

  • VIPS™ high efficiency multi-tasking single cell seeder
  • Cell Metric® high contrast whole-well imager
  • ICON™ productivity analyzer
  • STUDIUS™ data management system

Cell Sorting and Transfection Technologies

  • Wolf® Cell Sorter (Nanocollect Biomedical)
  • Neon™ Transfection System (Invitrogen)
  • ATx™ Electroporation Platform Generation 3 (MaxCyte®)

High Throughput Processing, Data Management, and Automation

  • Ambr® 15 (Sartorius)
  • Ambr® 250 (Sartorius)
  • Eppendorf® New Brunswick™ BioFlo 320 (10cc – 50cc BioBLU vessels)
  • ReadyToProcess WAVE 25 (Cytiva)
  • ÄKTA avant 150 (Cytiva)
  • PureTec(r) Automated TFF (SciLog)
  • Life Sciences R&D Cloud (Synthace)
  • Process Data Analytics Software (DataHow)
  • Maxwell® RSC 48 Instrument (Promega)
  • Eppendorf® epMotion(r) 96xl
  • ViaFlo 96 (Integra Biosciences)
  • Sorvall™ ST 16 Centrifuge (Thermo Scientific™)

Process and Protein Analytics

  • Vi-Cell™ XR Cell Viability Analyzer (Beckman Coulter)
  • Cedex Bio Analyzer (Roche)
  • BioProfile® FLEX2 (Nova Biomedical)
  • Octet® RH16 (Sartorius)
  • Prometheus Panta (NanoTemper Technologies)
  • Uncle (Unchained Labs)
  • Vanquish™ HPLC/UHPLC (Thermo Scientific™)
  • Maurice (ProteinSimple)
  • ICON™ (Solentim)
  • CFX384 Touch™ Real-Time PCR Detection System (Bio-Rad)

Incubators, Cold Chain, and Environmental Controls

  • Eppendorf® New Brunswick™ S41i CO2 Incubator Shakers (one dedicated per customer)
  • BD260 Standard Incubator (260 L)
  • 6’ and 4’ Biosafety Cabinets (Nuaire)
  • 2-8ºC (Thermo Scientific)
  • 2-8ºC (Walk-In)
  • -20ºC (Thermo Scientific)
  • -80ºC (Thermo Scientific)
  • Liquid Nitrogen Storage (Custom Biogenics)
  • AC600 Series Systems PCR Workstation
  • TRACEABLELIVE™ Temp Data Logger (Grainger)

Microscopy and Imaging

  • Echo Revolve 4 (RVL-110-m) Upright and Inverted
  • Fisher Scientific Micromaster Inverted
  • Cell Metric® high contrast whole-well imager (2nd system, Solentim)

Cell Line Development

Process Development

Analytical and Formulation Development

Our Team

Jesse McCool PhD LinkedIn

CEO and Co-Founder

Yuk Chun Chiu LinkedIn

Chief Operating Officer

Matt Hamilton LinkedIn

Chief Financial Officer

Stephen Hamilton PhD LinkedIn

Chief Technical Officer

Ming-Fang Zhou LinkedIn

VP Product Development

Christa Short LinkedIn

VP Process Development

David Schmidt LinkedIn

VP Analytical Development

Dawn Wofford LinkedIn

VP of Quality Assurance and Regulatory Affairs

Lance Johnson LinkedIn

VP of CGMP Information Systems

Mike Brem LinkedIn

Director of Cell Line Development

Aaron Morgan LinkedIn

Director of QC Analytical

Drew Wassel PhD LinkedIn

Director of Formulation Development

Clark Richardson LinkedIn

Director of Protein Purification

Anastasia Selyutina PhD LinkedIn

Senior Scientist, Molecular Biology

Alicia McLeod LinkedIn

Research Associate I

Alexandria Defaria LinkedIn

Research Associate I

Jenica Lee LinkedIn

Research Associate II

Our Board

Christian Kanady LinkedIn

Errik Anderson LinkedIn

Jesse McCool PhD LinkedIn

Our Advisory Board

Howard Levine PhD LinkedIn

Anshul Mangal LinkedIn

Edwin Beale LinkedIn

John Loser LinkedIn

Peter Rock LinkedIn

Gabriel McCool PhD LinkedIn

Lynne Frick LinkedIn

Marc Helouin LinkedIn

Join Our Team

Built by Scientists for Scientists

We are growing a team of drug development professionals who share a passion for speed to clinical impact through collaboration

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Wheeler Bio @ The Ziggurat
120 Robert S Kerr Ave
Oklahoma City, OK 73102
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Wheeler Bio R&D @ Alloy Therapeutics
275 2nd Ave, STE 200
Waltham, MA 02451
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655 Research Parkway, STE 383
Oklahoma City, OK 73104
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