High Touch Project Management
Cell Line Development Through ModularCMC™
As part of our ModularCMC™ platform, we provide drug developers with access to a dedicated service team, optimized vector production, and highly automated processes.
Program Types
Wheeler builds biologics programs by combining work packages to match your development scope. Select a program type below to see which packages are included or contact us to discuss a custom combination.
Contact UsAntibody-Based Therapeutics Work Packages
Innovation Thrives where CMC is Modular
The novel approach to CMC leverages data-science-driven analytics to create defined CMC work packages that can be combined for phase-appropriate deliverables.
Lead Selection
Utilize the robustness, speed and predictability of the ATUM Leap-In Transposon® system to optionally produce early representative material for Phase I studies from scalable stable bulk pools.
Cell Line Development
Utilize the robustness, speed and predictability of the ATUM Leap-In Transposon® system to optionally produce early representative material for Phase I studies from scalable stable bulk pools.
Rapid Tox Supply
Utilize the robustness, speed and predictability of the ATUM Leap-In Transposon® system to optionally produce early representative material for Phase I studies from scalable stable bulk pools.
Traditional Tox Supply
Utilize the robustness, speed and predictability of the ATUM Leap-In Transposon® system to optionally produce early representative material for Phase I studies from scalable stable bulk pools.
Lead to Clinic and Beyond
Utilize the robustness, speed and predictability of the ATUM Leap-In Transposon® system to optionally produce early representative material for Phase I studies from scalable stable bulk pools.
WP1
Stable CHO Pool Generation
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’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.