Modular CMC

Modular CMC Services

Modular CMC Services

Wheeler Bio’s Modular CMC services empower clients to navigate the complex biologics landscape with ease, delivering high-quality and scalable biopharmaceutical solutions for the benefit of patients worldwide. With Modular CMC, our team can deliver a seamless transition from early-stage development to manufacturing, ensuring efficiency, flexibility, and accelerated timelines.

This innovative approach enables clients to rapidly advance their biologic candidates from lead identification coming out of discovery to drug substance and drug product supply for clinical trials and beyond. The workflows integrate cell line development, process development, analytical development, and manufacturing services.

A New Tier of Customer Experience

Wheeler’s Modular CMC platform is underpinned by our steadfast commitment to advancing innovation through collaboration, data transparency, and platform accessibility. When integrated with antibody discovery processes, innovators benefit from:

Program Alignment

Modular work packages integrated into your overall product development plan

Process Freedom

Client-owned processes for de-risking scale-up and tech transfers

Speed to Clinic

Pool-based workflows enabling early and rapid progression through CMC milestones

From Discovery to IND

Drug innovators today are faced with difficulties in finding CDMOs that are focused on bridging the gap between drug discovery and first-in-human clinical studies. Modular CMC is a thoughtfully designed package of innovative services that integrates the translation from lab discovery into efficient and scalable clinical cGMP manufacturing.

Using innovative tools, advanced process and analytical methods for development and drug substance manufacturing along with data-science based tech-stacks, Modular CMC provides an efficient bundling of work packages, coupled with a high-quality data package, to deliver three core CMC development offerings — Lead to Manufacturability, Lead to Tox, and Lead to Clinic.

Interested to learn more about how Modular CMC is solving the translational gap?