Cellares: Accelerating Access to Life-Saving Cell Therapies

The pharmaceutical sector greatly enhances people's health and well-being, making it one of the most important sectors in the world. Research and innovation are the important components that fuel the sector’s growth by producing new therapies and medications to treat diseases and improve people’s quality of life. 

We witness the effects of innovation firsthand every day. Innovation in the pharmaceutical industry has a significant impact on millions of people's health and wellness, as well as the financial results of the businesses that supply it.

The corporate mission of the majority of pharmaceutical businesses centers around innovation, and they strive to create an internal culture capable of delivering this innovation to the market. Success comes with big benefits, and failure might endanger a business's ability to survive at all.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO), is pushing innovation in the pharmaceutical sector by using an Industry 4.0 strategy to mass produce the live medications of the twenty-first century.

To provide access to life-saving cell therapies, the business is creating and running integrated technologies for cell therapy manufacturing. With its Cell Shuttle, the company offers genuine walk-away, end-to-end automation by integrating all the technologies needed for the manufacturing process onto a high-throughput, flexible platform.

Boosting Opportunities for Life-Saving Cell Therapies

Using an Industry 4.0 strategy, Cellares is the first Integrated Development and Manufacturing Organization (IDMO) producing live pharmaceuticals for the 21st century in large quantities. To provide access to life-saving cell therapies, the business is creating and running integrated technologies for cell therapy manufacturing. With its Cell Shuttle, the company offers genuine walk-away, end-to-end automation by integrating all the technologies needed for the manufacturing process onto a high-throughput, flexible platform. To meet the entire patient demand for cell therapies on a global scale, Cell Shuttles will be installed in Cellares' Smart Factories across the globe. By collaborating with Cellares, academic institutions, biotech businesses, and pharmaceutical companies can expedite medication research, expand production operations, reduce manufacturing costs, and fulfill worldwide patient demand.

The company is headquartered in South San Francisco, California, with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The business has raised approximately $355 million in funding and is supported by top investors. 

The First Integrated Development & Manufacturing Organization

As the foundation of a vertically integrated business model that encompasses worldwide manufacturing services, Cellares' Integrated Development and Manufacturing Organizations (IDMOs) provide highly integrated and cutting-edge technologies.

In order to maintain its competitiveness and expand patient services, the therapeutic sector requires a system that is both scalable and affordable. These are the services that Cellares' IDMO provides in an effort to assist pharmaceutical firms in streamlining their operations and manufacturing at a considerably higher speed and volume.

• Technology Adoption Program (TAP)

TAP offers a quick and low-risk way for clients to automate and move their processes to the Cell Shuttle.

• Cell Therapy Process Development (PD)

Customers may streamline and automate their cell therapy procedure using Cellares IDMO. They can quicken process development for early-stage processes by utilizing the standardized Cell Shuttle templates.

• Analytical Development (AD)

Cellares offers its clients an automated and integrated analytical platform for accurate characterization of both the final product and the process.

• Clinical & Commercial cGMP Manufacturing

Customers can meet all patient demand throughout all stages of drug development and commercialization by leveraging Cellares' global network of IDMO Smart Factories.

• Quality Assurance and Quality Control Services

Cellares is a world-class organization with decades of combined experience in cell therapy that produces products that are of the highest caliber and comply with global cGMP regulations.

• Regulatory Support

For successful regulatory filings and amendments, CMC data package generation is supported by Cellares' regulatory experts.

Completely Coordinated, Expandable, Manufacturing System for Cell Therapy

Revolutionizing the cell therapy industry, Cellares' revolutionary Cell Shuttle technology processes 16 batches in parallel, offers 90% less labor, 90% less facility space required, and supports 90% of modalities (auto & allo). All of these benefits make Cellares' technology invaluable.

Through automation that removes operator error and contamination chances, the integrated Consumable Cartridge closes the process and reduces process failure rates by 75%. Since there is nothing comparable in the cell therapy market, the Cell Shuttle represents a significant advancement. The first true high-throughput, end-to-end manufacturing solution is called Cell Shuttle. If it's not integrated like the Cell Shuttle, it's not really end-to-end.

Facilitating the Production of Cell Therapies at Commercial Scale

• Integrated Automation

Every unit functions in a single consumable cartridge.

• High Throughput

16 cartridges maximum for multiple products manufactured at the same time

• Scalability 

Each Cell Shuttle can have up to 2,800 batches annually.

Cost Savings

At a projected commercial scale of 20,000 batches manufactured annually, Cellares' Cell Shuttle has the potential to lower CT manufacturing costs by 65%. Crucially, significant cost savings can be realized at much smaller scales: cost reductions of 63% can be realized at as little as 1,000 patient batches annually.

Integrated Software Suite Supports 90% of Cell Therapy Modalities

With the help of Process Design Studio, Cellares' Cell Shuttle suite provides customizable software that facilitates DOE and digital process development.

Clients use the same modular Consumable Cartridge for every process thanks to the Cell Shuttle's integrated technology. Because there is no need for hardware customization, the rate of technological adoption is also greatly accelerated.

Meet the Co-founder & CEO

Fabian Gerlinghaus is the Co-founder and CEO of Cellares.

“Unlock the full potential of your cell therapy by leveraging integrated cell therapy manufacturing technologies.”