PORTABLE CMC™

The Benefits of Portable CMC™

Speed, efficiency, predictability, and freedom

Wheeler Bio is changing the CDMO model with its Portable CMC™ platform, central US location, and steadfast commitment to collaboration, data transparency, and Pharma 4.0. Wheeler Bio’s platform is delivering a new tier of biomanufacturing quality, clinical timelines, and customer experience.

Portable CMC™ is a bundle of innovative services that accelerates the path to IND. With Portable CMC™, we simplify the connection between early drug discovery and clinical manufacturing — standardizing and democratizing the discovery to IND process.

Using state-of-the-art tools, technologies, data science and original methods for drug substance manufacturing and testing, Portable CMC™ provides an efficient bundling of three useful CMC development services — Lead Selection, Clone Selection, and CDMO Selection.

When integrated with antibody discovery processes, innovators benefit from shorter timelines, reduced risk of selecting lead molecules and processes that do not translate well into manufacturing, reduced risk of IND delays, increased momentum during technology transfer, and stronger negotiation positions with enterprise providers.

A New Tier of Customer Experience

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Predictable yields, timelines, and budgets

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Reduced regulatory risks during IND filings

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A standardized, freely transferable suite-ready manufacturing CMC package

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Open-source drug substance process with the freedom to go to any manufacturer

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Fixed fees, cost-efficiency, and transparent collaboration

Find out more about how you can get to IND faster with Portable CMC™ and a CRO partnership

Game Changing Partnerships

Through early collaboration with tech providers, DataHow and Synthace, Wheeler was able to build Portable CMC™ on top of an integrated, end-to-end digital biomanufacturing platform. Zurich-based DataHow specializes in data analytics and process modeling, offering digital solutions for process screening, monitoring, optimization, control, and scale-up. London-based Synthace provides a software layer called Life Sciences R&D Cloud that seamlessly automates experimentation and insight sharing.

Integrating these tools with Wheeler’s proprietary drug substance methods offers Wheeler’s emerging biotech partners access to powerful, predictive bioprocess modeling, enabling deeper scientific insights from each experimental run and overall reduction in effort, risks and costs in process development and manufacturing. Customers enjoy the benefits of reduced risk of IND delays, increased momentum during technology transfer, and stronger negotiation positions with enterprise providers.

From Discovery to IND

Scope of Portable CMC™ Services

Lead Selection

Clone Selection

CDMO Selection

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