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New Venture Announcement: ENABLE Biotech Next-Generation ATMP CDMO Capacity Update

Updated: Jun 26

BASEL/ZUG, SWITZERLAND, April 22, 2024– At the Swiss Biotech Days conference ENABLE Biotech AG (“ENABLE Biotech”), a Swiss next-generation CDMO focusing on the development and manufacture of advanced therapies, announced available capacity in its new R&D and GMP facility for clients developing early-stage cell therapies, gene-modified cell therapies such as CAR-T, and exosome therapies.



ENABLE Biotech’s focus is on providing start-up and spin-out companies in the advanced therapy space with a partner to support their unique challenges when it comes to preparing for early-stage clinical development. The team brings specific expertise and capabilities in process development and manufacturing ensuring a smooth transition into early-stage clinical testing. This also includes the necessary CMC expertise for supporting completion of dossiers for regulatory submissions. Our unique operating model enables attractive costs and a flexible, transparent workflow for sponsors. We focus on pre-clinical to Phase I/IIa production, and sponsors will be equipped to make the transition to a phase-adapted CDMO or in-house manufacturing when the time is right for late-stage clinical development. For seamless clinical trial initiation, the facility’s central location provides easy access to and from patients in Europe. Through our efficient resource utilization model, we also minimize costs to sponsors without compromising quality or timelines. By taking advantage of ENABLE Biotech’s available capacity now, ATMP developers can avoid delays to First-in-Human.


ABOUT ENABLE BIOTECH AG:

The next-generation CDMO model was conceptualized by industry veterans Alain Pralong, PhD, and Renaud Jacquemart, PhD, MBA. After establishing manufacturing processes and developing technologies for several companies including advanced therapy developers for over 25 years, Dr. Pralong recognized the need for support in process development, process industrialization, clinical manufacturing, CMC and regulatory activities, which is adapted and in sync with the needs, capabilities and means of start-up and spin-out companies as established CDMOs often expect sponsors to outsource or conduct these activities in house. With his 25 years of experience shared between biologics product development and CDMO operations, Dr. Jacquemart recognized the unique needs of small biotechs, which are not always met by modality-agnostic CDMOs. In 2023, they decided to find ENABLE Biotech alongside their colleagues and team members, with the mission to empower ATMP innovators with the knowledge, resources, and support they need to bring transformative therapies from concept to commercialization.


Consider partnering with ENABLE Biotech as YOUR next generation CDMO.

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