ATMP
Industrializing
Advanced Therapies
Cell & Gene Therapy
Pioneer in Advanced Therapy Manufacturing
We have vast experience in building GMP compliant, gene and cell therapy facilities from 5000 sq. ft. to over 500,000 sq. ft. using cutting-edge modular, emerging bioreactor and single-use technologies. We provide services to the leading gene and cell therapy companies, startups, CRO/CMOs, academia, hospitals and financial institutions throughout the US, Europe and Asia.
- Led over 10 facility builds greater than $750MM.
- Partnered with over 40 organizations serving ATMPs.
- Our playbook helped create the largest and most mature manufacturing footprint in the world.
- Partnered with two of the most notable, FDA approved advanced therapies.
- Led the development of new technologies and equipment for advanced therapies.
- Have experience with all equipment for ATMPs from early beta versions to current.
ATMP Expertise
Our Services & Experience
Our advanced therapy services and experience includes:
- Advanced Therapy Facility Builds
- Make vs. Buy Business Strategy
- Site Selection Research & Analysis
- Owner's Representation
- CRO/CMO, Vendor Selection & Management
- Equipment Selection & Procurement
- Tech Transfer
- Emerging Bioreactor Technology
- Single-Use Technologies
- Modular Cleanrooms
- Cell & Gene Therapy Process Validation
- Engineering, Automation, Reliability & Maintenance
- Quality, Regulatory, & Compliance
- Operational Readiness
- Facility Turnover
Our Playbook
Our "ATMP," Advanced Therapy Manufacturing Playbook
Project Farma is a pioneer in advanced therapy manufacturing and has developed a playbook that has been tried and tested by the leading cell and gene therapy organizations. Using this playbook, we have led the creation of the largest cell and gene therapy manufacturing footprint in the world and the commercialization of two of the most notable FDA-approved therapies. This playbook has not only been used by the leading advanced therapy companies, but also by startups, CRO/CMOs, academia, hospitals and financial institutions. This playbook contains the entire process life cycle from the list below to other key items needed for advanced therapies. This playbook has been instrumental in saving lives by bringing therapies to market in record time and simplifying and streamlining a complex manufacturing environment without sacrificing quality and safety.
- Business Strategy
- Organizational Charts & Resource Modeling
- Group Identification & Job Descriptions
- Make vs. Buy Business Case Analysis
- Facility & Process Requirements
- Project Setup, Org. Charts, Roles & Responsibilities
- cGMP Programs, Policies & Procedures
- cGMP Specifications & Procurement
- Commissioning, Qualification, Validation
- Quality Management Systems
- Critical Swim Lanes
- Automation
- Engineering Strategies
- Training & Development
