Custom Antibody Development and Manufacturing Services

Our antibody experience provides dedicated custom antibody discovery and antibody development expertise, guiding clients towards the clinic with unparalleled support, speed, and customizability, as a true integrated partner. Our concept-to-cure support helps clients avoid the typical momentum drop between discovery and process development, letting them bypass significant challenges and technical, financial, and regulatory risks.

Our industry-leading experience in antibody discovery services, safety, and analytics, combined with Wheeler Bio’s CMC development platform, significantly accelerates antibody discovery to IND submission by efficiently connecting the preclinical, clinical manufacturing, and release testing journeys and reducing the complexity of working with multiple vendors. The unique integration of a CRO with a CDMO provides a seamless workflow and client journey.

Wheeler Bio’s Portable CMC® platform allows clients to scale custom antibody development from a pool of discovery candidates (4-6) and drive parallel decision-making on manufacturing developability while narrowing down the lead candidate pool to a clinical candidate and back-up candidates. Once a lead is selected, Wheeler Bio can scale and release material for Safety Assessment. Wheeler Bio will work alongside the client throughout the IND-enabling journey, to make sure Drug Substance and Drug Product are ready for submission and initiation of clinical trials.

digital rendering of a monoclonal antibody

Zero to Antibody Hero: Laying the Groundwork for Preclinical Success
Are you doing everything you can to de-risk your antibody candidates? What does it take to go to preclinical development with a high degree of confidence? View this webinar to follow the journey of an antibody ‘candidate hero’ as it progresses through the early discovery gauntlet.
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Integrative Custom Antibody Workflow

STEP 1

Hit Discovery

  • Discover a well-characterized lead panel using Charles River’s industry-leading in vitro phage display libraries – SuperHuman™, Cosmic™, or Tungsten VHH™

STEP 2

Lead Optimization and Characterization

  • Down select up to 50 unique leads to a smaller panel of 4-6 antibodies for lead and back-up candidate selection
  • Mechanism of Action and Effector Function studies

Discovery Phase Antibody Development and Manufacturing

  • Develop CHO clone pools of your 4-6 leads
  • Assessment of formulation and manufacturability for top lead selection
  • Material generation for late-stage in vitro and in vivo candidate selection studies

STEP 3

Lead Candidate Selection

  • Off-Target assessment using Charles River’s Retrogenix® Cell Microarray technology
  • Developability assessment
  • In vitro cytotoxicity assays
  • ADME and pK studies
  • In vivo efficacy and pharmacology studies in relevant disease models

Non-GMP Antibody Scale-up for IND-enabling Studies

  • CHO Pool rapid supply of purified drug substance and full characterization data package for toxicology studies
  • Parallel cell line development cloning to enable subsequent CGMP stages

STEP 4

IND-enabling Studies

  • Standard IND package run for monoclonal antibodies with regulatory data package submission for IND

Clinical Ready Supply

  • Reliable CGMP released bulk drug substance and drug product
  • Scale-up and release testing data and methods
  • IND submission regulatory support

Learn how we can aid your custom antibody development from end to end.

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a monoclonal antibody molecule

WHITE PAPER- Antibodies: The Breakthrough Past, Blockbuster Present, and Cutting-Edge Future
This is an essential read for any company looking to build a biologics pipeline and seeking a deeper understanding of this advanced modality and how it is transforming the industry.
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