Wheeler Bio utilizes its Portable CMC® platform to streamline the transition from drug discovery to clinical supply by offering modular development services, including mammalian cell line and process development. This approach addresses the significant delays and risks associated with the traditional drug development pipeline, enabling biopharma companies to accelerate their path to IND filing.
Funding
$44M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
CREIFounders
Product
Problem
Biopharmaceutical companies face significant challenges in transitioning from drug discovery to clinical supply, including delays, high costs, and technical and regulatory risks. Traditional contract development and manufacturing organization (CDMO) models often lack the agility and flexibility required to efficiently support emerging biopharma companies with limited resources. This can result in misalignment with innovator timelines and funding realities.
Solution
Wheeler Bio offers a Portable CMC® platform that streamlines the path from drug discovery to clinical manufacturing, addressing the translational gap with modular development services. The platform provides an open-source, technology-stacked approach that integrates discovery CROs and CDMOs, delivering speed, efficiency, and predictability. Wheeler Bio's services include cell line development, process and analytical method development, process demonstration, and technology transfer into CGMP production. The Portable CMC® platform is designed to align with innovator timelines and funding milestones, offering a more accessible and affordable solution for early-clinical-phase biologics services.
Target Audience
Wheeler Bio primarily serves biotechnology startups and emerging biopharma companies focused on developing therapeutic antibodies and other biologics, particularly those seeking to accelerate their path to IND filing and first-in-human trials.
Features
- Modular CMC services including Lead to Manufacturability, Lead to Tox, and Lead to Clinic
- Open-source, client-owned processes for de-risked scale-up and tech transfer
- Stable bulk cultures (SBCs) for rapid material generation and asynchronous workflows
- cGMP Master Cell Banking and drug substance manufacturing
- Analytical method development and qualification
- Formulation development
- Toxicology material supply
- Integration with Leap-In Transposase® (ATUM) for efficient cell line development
- RightSource SM quality control testing lab operated by Charles River Laboratories
- Utilizes Ambr® minibioreactor systems for clone selection, process optimization, and scale-up