Now, under one roof, cell and gene therapy companies are able to get everything they need to quickly create a CGMP compliant facility.

Facility design, traditional or modular construction, it's all included in CarTon.

The Need for CarTon

Industry and Regulatory Challenges

The CarTon includes quality by design CGMP facility and compliance; commissioning, qualification & validation; and operational readiness/quality management systems and services.

Commissioning, Qualification & Validation

Standardized Templates & Integrated Approach Engineering Turnover Packages and Document Control Start-up and Construction QA Commissioning Facilities, Systems and Equipment Qualification Airflow Visualization Studies Environmental Monitoring Performance Qualification Media Fills and Aseptic Process Simulations Computer System Validation and Data Integrity Process and Cleaning Validation Sterilization Validation QC and Analytical Methods Transfer and Validation

Quality by Design CGMP Facility and Compliance
	Manufacturing and Contamination Control Strategy Product Definition (CQAs) / Process Design (CPPs) User Requirements CGMP Facility Design Reviews / DQ Quality and Regulatory Approval Strategy Risk Assessments (ICH Q9) Validation Strategy (VMP) Life Cycle Documentation Requirements

Manufacturing Readiness & Quality Management Systems

Program & Project Management Quality Management System (QMS) Development Tech Transfer / Scale-up Pre-Approval Inspection Readiness CGMP / Internal Audit Program Materials and Information Management Systems (ERP/LIMS) Supplier Audits / Vendor Management / Quality Agreements) Operation and Maintenance SOPs Recruiting / Staffing / Training Calibration / PM Program Development Cleaning / Disinfection / EM Strategy Continuous Improvement Program

IPS Provides a Complete Turnkey Solution - Vial to Vial

With the combination of IPS’ core services, iCON, and CarTon, cell and gene therapy companies have a complete turnkey solution to get their medical brilliance to awaiting patients, iCON, the IPS and G-CON collaboration, provides for the most flexible and rapidly deployable facility platform, meeting the modular and mobile demands of the industry. The broad range of technical capabilities along with prefabricated cleanroom PODs provides a true turnkey solution to biopharmaceutical manufacturers and CMO companies with needs for production agility and capacity flexing. CarTon takes the iCON solution one-step further to a fully operational, integrated facility or as an independent operational readiness solution on any project.