Portable CMC®
CMC & Developability
Information
Wheeler Bio’s Portable 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 Portable 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. The workflows integrate cell line development, process development, analytical development, and manufacturing services.
Wheeler’s Portable 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:
Funding Alignment
o Modular work packages aligned to your product’s development and fundraising milestones
Accessible Platform
o Reduced risk with a predictable scope and no large upfront financial commitments
Affordable Workflow
o All-inclusive pricing with the option to defer cloning until programs are clinic-ready
Process Freedom
o Open-source, client-owned processes for de-risking scale-up and tech transfers
Speed to Clinic
o Pool-based workflows for rapidly progressing through CMC milestones
Using innovative tools, advanced process and analytical methods for development and drug substance manufacturing along with data-science based tech-stacks, Portable 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 — to provide our clients with a new tier of accessibility.
