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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

Time is Lives

Where speed to market is critical for saving lives, our solution simplifies the complex maze of activities required to bring a new cell and gene therapy facility to a fully operational state. CarTon contains the entire process life cycle including facility and process requirements, standardized protocol templates, QMS/SOP development, training, and other necessities for CGMP manufacturing in a global market.

 

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

Regulatory Challenges for the cell and gene therapy industry.
  • 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

Regulatory Challenges for the cell and gene therapy industry.
  • 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

Regulatory Challenges for the cell and gene therapy industry.
  • 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.

 

An industry leader in technical consulting, engineering, procurement, construction management, CQV, & CGMP compliance for the ATMP industry. A turnkey facility solution for cell & gene therapy manufacturing. A complete operational readiness solution complete in one box – The CarTon.

 

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