High Touch Project Management
Program Scope with ModularCMC™
ModularCMC streamlines biologics development through structured, configurable work packages that shorten timelines and support informed decision-making at every stage.
Program Types
Wheeler Bio builds biologics programs by combining work packages to match your CMC development strategy. Select a program type below to see which packages are included or contact us to discuss a custom combination.
Contact UsModular Work Packages
Innovation Thrives where CMC is Modular
This flexible approach to CMC leverages data-science-driven analytics to create defined CMC work packages that can be combined for phase-appropriate deliverables.
Lead Selection
Transfection to top pool selection in as few as 3 months
Cell Line Development
Transfection to MCB conditional release in as few as 6 months
Rapid Tox Supply
Transfection to SBC derived toxicology material supply in as few as 3 months
Traditional Tox Supply
Transfection to clonally derived toxicology material supply in as few as 6 months
Lead to Clinic
Transfection to Drug Product release in as few as 10 months
WP1
Stable CHO Pool Generation and Selection
WP2
Process, Analytical, and Formulation Development
WP3
Single Cell Cloning and Selection
WP4
Master Cell Banking
WP5
Cell Line Stability Assessment
WP6
Non-cGMP Drug Substance Scale-Up
WP7
cGMP Drug Substance Material Supply
WP8
Drug Product Management, Release Testing, and Stability Study
WP9
Support for CTD Module 3 Documentation Preparation
Don’t See Your Scope?
The five program types above are common starting points, but every biologics program has its own shape. Wheeler Bio’s work packages are designed to combine in many configurations, including ones not listed here. If your program needs a different scope, talk with our team about building a custom program around the modules that fit.