Cellares emerges as the pioneering Integrated Development and Manufacturing Organization (IDMO), leading the charge in revolutionizing cell therapy manufacturing for the 21st century. Embracing the principles of Industry 4.0, the company stands at the forefront of mass-producing the cutting-edge living drugs of today. Distinguished by its approach, Cellares not only develops but also operates integrated technologies specifically tailored for cell therapy manufacturing. Their overarching mission is to address the escalating global demand for cell therapies, ensuring widespread access to innovative and transformative treatments for patients worldwide. With a keen focus on technological integration and an unwavering commitment to meeting total patient demand, Cellares stands as a trailblazer in the realm of advanced medical therapeutics.

First Integrated Development & Manufacturing Organization (IDMO)

Cellares leads the Integrated Development & Manufacturing Organization (IDMO) sector, harnessing highly advanced and integrated technologies within a vertically integrated business model that encompasses global manufacturing services. As a premier IDMO, Cellares offers a range of specialized services tailored to various stages of the drug development process.

Technology Adoption Program (TAP): Streamlining Automation Processes Through Cellares' Technology Adoption Program (TAP), businesses gain access to a swift and low-risk opportunity to automate and transfer their processes onto the innovative Cell Shuttle platform. This initiative expedites the automation process, ensuring heightened efficiency and reliability.

Cell Therapy Process Development Expertise In the domain of cell therapy process development (PD), Cellares IDMO provides expertise in optimizing and automating cell therapy processes. Leveraging standardized Cell Shuttle templates, businesses can accelerate PD for early-stage processes, thereby enhancing their overall development timeline.

Advanced Analytical Development Solutions: For analytical development (AD), Cellares delivers an automated and integrated analytical platform, guaranteeing reliable in-process and final product characterization. This advanced system enhances accuracy and consistency in product analysis, bolstering confidence in product quality.

Clinical and Commercial Current Good Manufacturing Practice (cGMP) Manufacturing: Cellares' capabilities extend to clinical and commercial Current Good Manufacturing Practice (cGMP) manufacturing. Leveraging a global network of IDMO Smart Factories, Cellares addresses total patient demand across all drug development and commercialization phases, ensuring a seamless transition from development to market.

World-Class Quality Assurance and Regulatory Support: In addition to manufacturing expertise, Cellares boasts a world-class Quality Assurance and Quality Control team with extensive experience in cell therapy. This dedicated team ensures products meet global cGMP requirements, maintaining the highest levels of quality throughout the production process. Furthermore, Cellares offers comprehensive regulatory support, assisting businesses in generating Chemistry, Manufacturing, and Controls (CMC) data packages essential for successful regulatory filings and amendments.

Pioneering Integrated Solutions: As a pioneering IDMO, Cellares offers a suite of specialized services, from technology adoption and process optimization to analytical development, manufacturing, quality assurance, and regulatory support. These integrated solutions empower businesses at every stage of drug development, ensuring efficiency, quality, and compliance.

Technology Adoption Partnership (TAP)

The Technology Adoption Partnership (TAP) offered by Cellares presents a swift and low-risk avenue for partners to automate and transfer their cell therapy processes onto the innovative Cell Shuttle platform.

• In the initial phase of TAP, partners share their process information with Cellares, allowing the organization to establish a tailored process automation plan. Cellares then provides a process-specific per batch price, ensuring transparency and clarity in the partnership.
• During the transfer stage, individual unit operations are automated and transferred, with analytical support provided as needed to facilitate automation seamlessly.
• The final phase involves full automation of the partner's process, ensuring an end-to-end automated run. The data generated through the TAP process supports regulatory filings, streamlining the approval process for partners.

Remarkably, the entire TAP process can be completed in six months or less, underscoring its efficiency and rapidity. Partnering with Cellares empowers academic institutions, biotech, and pharmaceutical companies to expedite drug development, scale manufacturing, reduce process failure rates, lower manufacturing costs, and effectively address the global patient demand. This collaborative approach signifies a significant step toward accelerating innovation and ensuring the timely delivery of life-saving therapies to patients worldwide.

About | Fabian Gerlinghaus

Fabian Gerlinghaus is a Co-Founder and the Chief Executive Officer of Cellares. He is driven by a strong sense of purpose and is passionate about building the future of cell therapy manufacturing. With 10+ years of experience as an innovator and a leader, Fabian has established a track record of assembling top-performing teams to successfully drive novel bioprocessing technologies from ideation to commercial readiness. Prior to co-founding Cellares, Fabian served as Chief Innovation Officer at Synthego, where he co-invented the company’s proprietary RNA synthesizer technology and helped grow the company from five to more than 230 employees. He successfully led the interdisciplinary team that took synthesizer technology from whiteboard sketch to production-ready instruments within two years, enabling the company to be the first to market with its CRISPR/Cas9 product portfolio. He earned a master’s degree in aerospace engineering from the Technical University of Munich, and an honours degree in technology management from the Center for Digital Technology and Management, Munich.

“Partnering with Cellares empowers institutions and companies to expedite drug development, reduce costs, and meet global patient demand, accelerating innovation and delivering life-saving therapies worldwide.”