Built for the Realities of CDMO Operations
CDMOs operate at the intersection of speed, compliance, and flexibility, serving multiple sponsors, programs, and regulatory expectations within shared facilities. Title21 Manufacturing provides a unified, GMP-validated platform built to support multi-client operations, reduce operational risk, and accelerate batch throughput without adding system complexity.
Manage Runs in Parallel
Each client has their own unique requirements and each run has its own unique process. Keep process development, work, planning, manufacturing time, analytics and reporting in one place to ensure accuracy while saving time.
Centralize Knowledge
Keep all necessary information in one location to easily see what is happening now or what happened before.
One Platform. Built Around Your Facility
Our back office and companion app come standard. Add the pre-configured modules and extensions that support your workflows.
Cleanroom Cleaning
Manage tasks to keep cleanrooms clean.
Cleanroom Testing
Validate that your cleanroom is within specifications.
Electronic Batch Records (eBR)
Track any production process.
Environmental Monitoring (EM)
Organize sample plans and automate trending.
Sample Tracking
Know where your samples are in the testing process.
Proven Impact
Organizations leveraging Title21 Manufacturing have achieved measurable efficiency gains.
Faster documentation time.
Fewer manual errors.
Higher productivity across production and QA teams.
From Work Instructions to Real-Time Data
How it Works
Title21’s Electronic Batch Recording app provides interactive step-by-step work instructions and enables the user to collect process data in real-time.
The workflows are extremely versatile. Additionally, since the app is compatible with both tablets and computers, Title21 digitizes any workflow in manufacturing, material reception, quality control, or maintenance.
Get up and running quickly by starting from our library of standard unit operations. Make use of Title21’s smart workflow configuration to anticipate variations in process executions.
Solution Overview
Title21 Manufacturing
Download the Title21 Manufacturing Solution Overview to see how Title21 delivers a unified digital manufacturing solution built specifically for cell & gene therapy, CDMOs, and GMP facilities.
Complete the form to download.
See Title21 Manufacturing for CDMOs in Action
Schedule a demo of Title21 Manufacturing and see how teams replace paper, reduce deviations, and gain real-time visibility from batch start to release.