Portable CMC™ Services
Portable CMC™ Services
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 by integrating cell line development, process development, analytical development, and manufacturing services. There are 10 work packages that comprise the three Portable CMC™ offerings with agile optionality that results in a new tier of accessibility from venture backed biotechs to mature biopharma product developers.
A New Tier of Customer Experience
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:
Modular work packages aligned to your product’s development and fundraising milestones
Reduced risk with a predictable scope and no large upfront financial commitments
All-inclusive pricing with the option to defer cloning until programs are clinic-ready
Open-source, client-owned processes for de-risking scale-up and tech transfers
Speed to Clinic
Pool-based workflows for rapidly progressing through CMC milestones
Learn more about how Portable CMC™ can bridge the gap between discovery and IND. Connect with us.
From Discovery to IND
Drug innovators today are faced with difficulties in finding CDMO providers that are focused on bridging the gap between drug discovery and first-in-human clinical studies. Portable 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, 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.
Portable CMC™ Work Packages
- 1. Product Quality Assessment in Stable Bulk Pools
- 2. Manufacturability Assessment in Stable Bulk Pools
- 3. Single Cell Cloning and Development Cell Banking
- 4. Master Cell Banking
- 5. Master Cell Bank Stability Testing
- 6. Rapid Toxicology Supply
- 7. Clinical Material Supply
- 8. Drug Product Manufacturing
- 9. Support for CTD and Document Preparation
- 10. Tech Transfer
An Accelerated Path to the Clinic
Based on our most commonly selected work packages, our core offerings are designed to meet your CMC milestones with flexibility: