Manufacturing Services
Manufacturing for Antibody-Based Therapeutics
Drug substance manufacturing services to support from early development through cGMP manufacturing
Drug Substance Manufacturing
Wheeler Bio supports early phase non-cGMP drug substance supply through all phases of cGMP supply, with manufacturing campaigns capable of producing kilogram-scale quantities of drug substance.
High-Science Manufacturing
Our facility is designed for flexible and efficient cGMP manufacturing, utilizing ballroom suites with single-use bioprocessing systems that enable accelerated and reliable tech transfer and the production of drug substance.
Wheeler Bio’s cGMP drug substance manufacturing capability spans monoclonal antibodies, multispecific antibodies, Fc-fusion proteins, and mammalian-expressed recombinant proteins, supporting programs from IND-enabling through cGMP manufacturing. The manufacturing facility is designed for flexible and efficient cGMP manufacturing, reliable tech transfer, and production of drug substance at kilogram-scale quantities.
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high-science, high-touch
Manufacturing Built to Scale
cGMP Drug Substance Manufacturing
Execution of fed-batch production campaigns in single-use bioreactor systems in a ballroom suite manufacturing facility to deliver formulated bulk drug substance at kilogram-scale quantities
Reference Standard Preparation and Characterization
Preparation, fill, and analytical characterization of cGMP drug substance reference standards to support QC release testing and long-term analytical program continuity
QC Release Testing and Batch Disposition
QC testing of cGMP drug substance against approved release specifications, with Quality review of executed batch records and generation of a Certificate of Analysis (CoA) with cGMP compliance statement to support batch disposition and clinical releaseSpeed to Clinic
Designed for speed to clinic: tech transfer, manufacturing, and release under one roofSingle-Use Bioprocessing
Single-use bioprocessing systems, purpose-design for rapid campaign changeover and manufacturing flexibilityQuality Oversight
Quality oversight embedded at every stage, from raw material release to batch disposition and CoADrug Substance Manufacturing with ModularCMC™
Accelerate drug substance manufacturing programs with phase-appropriate ModularCMC
Drug Product Manufacturing
Wheeler manages drug product from cGMP drug substance release through fill-finish coordination, drug product release testing, and ICH Q1A(R3)-aligned stability with the goal of providing a single point of coordination from drug substance release to drug product supply delivery.
Partnering for Success
Fill-finish scheduling, container-closure selection, and drug product release specifications are designed to be integrated into the overall program plan from the start of the engagement. Fill-finish operations are conducted through Wheeler Bio’s partnership allowing seamless high-touch project management throughout the process.
Explore Fill-Finishhigh science execution
Manufacturing with ModularCMC
ModularCMC streamlines biologics development through structured, configurable work packages that shorten timelines and support informed decision-making at every stage.
