Purpose-Built cGMP Manufacturing Facility for Optimized Cell Therapy Production
Our brand-new cGMP manufacturing facility in The Woodlands, TX, marks a pivotal achievement in Cellipont’s dedication to advancing cell therapy development and manufacturing for patients around the globe. This innovative, purpose-built facility features a flexible infrastructure and adaptable solutions tailored to the unique needs of each client and product. With multiple modular manufacturing suites of various sizes, we can utilize a broad range of equipment to create an efficient and robust clinical manufacturing process, specifically optimized for your cell therapy product, ensuring unparalleled precision and control.
Facility Highlights
Our facility is designed to provide exceptional precision and control, ensuring an efficient and robust clinical manufacturing process for your specific cell therapy product. Key features include:
- Seven Modular Cleanroom Suites: Multi-product manufacturing capabilities that will accommodate diverse project needs
- Integrated Quality Control Laboratories: Onsite QC for in-house release & stability testing
- Temperature-Controlled Storage Solutions: Ensuring the integrity of your products
- Segregated Shipping Bays and Warehouse: Dedicated receiving and shipping bays for isolated material flow
Cutting-Edge Technologies
We leverage the latest technologies to enhance our manufacturing capabilities:
- Automated Closed Processing Systems: Including Lovo®, CliniMACS Prodigy®, and Xuri™ systems
- Cryogenic Storage and Logistics Solutions: Ensuring the safe and efficient handling of cell therapy products
- Robust Supply Chain Management Systems: Streamlining operations and ensuring timely delivery
Why Partner with Us for Manufacturing?
Efficiency and Reliability
We prioritize efficiency, reliability, and adherence to regulatory guidelines, ensuring your cell therapy projects are in safe hands.
Scalability and Flexibility
With an additional 12,000 sq. ft. of expansion space, Cellipont can build customized cleanrooms to meet your evolving patient needs, providing scalability and flexibility for your cell therapy programs.
Robust Infrastructure
Our facility is equipped with a two-grid electrical feed and a full building backup generator with UPS, ensuring uninterrupted operations and minimizing the risk of downtime.
Comprehensive Facility Specifications
- Total Area: 76,000 sq. ft.
- Clean Rooms: 7 Grade B Clean Rooms (~450 sq. ft. each) with 2 BSCs/Room.
- Expansion Plans: Additional 6 clean rooms adaptable to meet client specifications.
- Compliance: Meets both U.S. and E.U. standards.
- Flow Management: Unidirectional flow of people, material, and waste.
- HVAC Systems: Single pass and individual HVAC unit per room.
- Redundancy: Redundant chiller and electrical systems (2 grid electrical feed with full building backup generator).
- Centralized LN2 Storage: 6,000-liter capacity.
Partner with Cellipont Bioservices
At Cellipont, we are committed to providing our customers with the most advanced manufacturing capabilities, enabling the efficient and reliable production of cell therapies that can transform patients’ lives.
Contact us today at [email protected] to explore how our purpose-built facility can support your cell therapy program.