MODULAR CMC
The Benefits of
Modular CMC
Accelerate Your Path
to Clinic
Providing Accessibility, Speed, and Predictability from Discovery to IND
Wheeler Bio’s Modular CMC platform is an open-source tech stack of pre-clinical and clinical development services based around discrete CMC milestones. Modular CMC is designed to empower innovators by reducing the risks – and costs – involved in bringing antibody therapeutics from discovery to clinic.
Leveraging Wheeler’s well-characterized, QbD-based platform for drug substance manufacturing and testing, Modular CMC offers a flexible and streamlined approach to process and analytical development that can be tailored to your program’s milestones, budget, and fundraising timelines. Our core offerings are designed to meet your CMC milestones with flexibility.
The Benefits of Modular CMC
Experience the freedom provided by our open-source process platform that offers a de-risked pathway for scale-up and tech transfers to manufacturing. Modular program design provides in-built flexibility, so that innovators are not locked in for the whole CMC process, retain process ownership and can tech transfer out without penalty at any stage. Work packages are strategically modular and highly-accessible, minimizing risk and eliminating the need for significant upfront financial commitments.
Modular CMC is purposefully designed to accelerate your product’s journey from discovery to the clinic at half the total program cost charged by traditional CDMOs.
Funding Alignment
Modular work packages aligned to your product’s development and fundraising milestones
Accessible Platform
Reduced risk with a predictable scope and no large upfront financial commitments
Affordable Workflow
All-inclusive pricing with the option to defer cloning until programs are clinic-ready
Process Freedom
Client-owned processes for de-risking scale-up and tech transfers
Speed to Clinic
Pool-based workflows for rapidly progressing through CMC milestones
Modular CMC with Wheeler Bio
