Business Fortune
The industry's growth depends on changing the way cell therapy is manufactured; the market is predicted to expand from $6.12 billion in 2025 to $23.27 billion by 2034. Reducing expenses, increasing productivity, and satisfying the growing demand for cell treatments all depend on streamlined, scalable production procedures. Without these developments, companies may encounter difficulties including delayed innovation, increased production costs, and operational inefficiencies, which would eventually restrict patients' access to ground-breaking therapies. This is where Cellares comes in, employing its integrated development and manufacturing organization (IDMO) strategy to revolutionize the manufacture of cell therapies.
Making Life-Saving Cell Therapies More Accessible
As the first Integrated Development and Manufacturing Organization (IDMO), Cellares uses an Industry 4.0 methodology to produce the 21st-century living medications in large quantities. In order to satisfy the whole patient demand for cell treatments worldwide, the firm is both creating and running integrated technologies for cell therapy production.
The company's Cell Shuttle™offers real walk-away, end-to-end automation by combining all the technologies needed for the whole manufacturing process into a versatile, high-throughput platform.
The Cell Q™ automates quality control at high throughput for both in-process and release QC, while the Cell Shuttle automates the manufacture of cell therapies. To satisfy all patient demand for cell treatments, Cellares' Smart Factories worldwide will be equipped with Cell Shuttles™ and Cell Qs™.
Cellares, which has its headquarters in South San Francisco, California, and its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, helps pharmaceutical companies, biotechnology companies, and academic medical centers meet global patient demand, reduce manufacturing costs, and speed up the development of cell therapies.
The First Integrated Development and Manufacturing Organization (IDMO)
IDMO Services: Clinical & Commercial cGMP Manufacturing
Cellares provides services like cGMP manufacturing, process and analytical development, regulatory support, and tech transfers under the Integrated Development and Manufacturing Organization (IDMO) model. Their platform seeks to expedite the translation and automation of cell treatments, assisting companies in expanding internationally, cutting expenses, and accelerating development. The flexibility of their service models allows tailored solutions for different stages of therapy, with options for shared or dedicated facilities.
The IDMO Journey: Working with the Cellares IDMO
Cellares provides an integrated development and manufacturing organization (IDMO) approach that uses automated technology to speed up the manufacture of cell therapies. With benefits including a quicker transition to cGMP production and lower batch costs, their strategy drastically cuts down on the time needed for clinical trials and commercialization. Additionally, they offer opportunities for scalable international expansion through technology transfer across several geographies. Cellares works with top pharmaceutical firms to promote innovation in the field of cell therapy.
Begin your journey: By automating your process or using Cellares' Standard CAR-T Process
In order to speed up and scale up production, Cellares provides a global network of smart factories, flexible service models for cell therapy manufacturing (such as shared, hybrid, and dedicated models), and a focus on cost reduction and process speeding (such as cutting time to IND and BLA by up to 50%).
Globalization Package: Accelerate Cell Therapy Access through Cellares' Global IDMO Network
Using its worldwide network of smart factories in the US, Europe, and Japan, Cellares provides a Globalization Package to assist in the expansion of cell treatments into new markets. By using Cellares' regulatory experience, this solution enables cost reductions, scalability to meet worldwide demand, and speedy tech transfer. They provide customizable service models that are suited to various stages of the development of cell therapy, including dedicated, hybrid, and shared.
Service Models: Flexible IDMO Service Models
For the production of cell therapies, Cellares provides three adaptable service models: shared, hybrid, and dedicated. Designed for different stages of growth, each model offers varying degrees of flexibility and capability. While the Dedicated Model guarantees high-volume output and is best suited for commercial-phase assets, the Shared Model allows for flexibility with regard to timing and volume. For developers at various phases of clinical and commercial development, these models aid in manufacturing and scale optimization.
IDMO Partners: Cellares collaborates with 5 of the top 8 cell therapy pharma leaders
To improve the production of cell therapies, Cellares collaborates with significant pharmaceutical firms such as Lyell, Bristol Myers Squibb, and Cabaletta Bio. Notable partnerships include proof-of-concept production for CAR-T cell treatments, validation of Cellares' Cell Shuttle technology, and international capacity agreements. These collaborations aid in maximizing the potential of automated, scalable manufacturing to optimize cell therapy production procedures.
Fabian Gerlinghaus |Co-Founder & CEO
Fabian Gerlinghaus is the Co-Founder and CEO of Cellares, motivated by a desire to increase access to cell treatments worldwide. With more than ten years of leadership and innovation expertise, he is an expert at putting together elite teams and taking bioprocessing innovations from idea to market. In his previous role as Chief Innovation Officer at Synthego, he helped grow the business from five to 230 workers and co-invented the company's RNA synthesizer. He oversaw the group that completed the synthesizer's development in less than two years. Fabian graduated from Munich with an honors degree in technology management and a master's degree in aerospace engineering.
