CIO Bulletin

Cellares: Pioneering the Future of Cell Therapy Manufacturing with Industry 4.0 Innovation

Cellares emerges as the pioneering Integrated Development and Manufacturing Organization (IDMO), spearheading the revolution in cell therapy manufacturing for the 21st century. Embracing the principles of Industry 4.0, the company is at the forefront of mass manufacturing the cutting-edge living drugs of the modern era. Cellares uniquely positions itself as an organization that not only develops but also operates integrated technologies tailored for cell therapy manufacturing. Their mission is to fulfill the growing global demand for cell therapies, ensuring that patients worldwide have access to innovative and life-changing treatments. With a focus on technological integration and a commitment to meeting total patient demand, Cellares stands as a trailblazer in the realm of advanced medical therapeutics.

First Integrated Development & Manufacturing Organization (IDMO)

The Integrated Development & Manufacturing Organization (IDMO) industry offers highly advanced and integrated technologies within a vertically integrated business model, incorporating global manufacturing services. Within this landscape, Cellares, as a leading IDMO, provides a range of specialized services tailored to various stages of the drug development process.

Under Cellares' Technology Adoption Program (TAP), businesses have access to a rapid and low-risk opportunity for automating and transferring their processes onto the innovative Cell Shuttle platform. This initiative streamlines and accelerates the automation process, ensuring efficiency and reliability.

In the realm of cell therapy process development (PD), Cellares IDMO offers expertise in optimizing and automating cell therapy processes. Leveraging standardized Cell Shuttle templates, businesses can expedite PD for early-stage processes, enhancing their overall development timeline.

For analytical development (AD), Cellares provides an automated and integrated analytical platform, ensuring reliable in-process and final product characterization. This advanced system enhances accuracy and consistency in product analysis.

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

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 that products meet global cGMP requirements, maintaining the highest levels of quality throughout the production process.

Furthermore, Cellares offers comprehensive regulatory support. Their team of regulatory experts assists in generating Chemistry, Manufacturing, and Controls (CMC) data packages, crucial for successful regulatory filings and amendments. Through their support, businesses can navigate regulatory requirements confidently, facilitating the approval process for their products.

Cellares, as a pioneering IDMO, offers a suite of specialized services, from technology adoption and process optimization to analytical development, manufacturing, quality assurance, and regulatory support. Their 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.