Cellevate caps strong 2025 by achieving ISO 9001:2015 certification and implementing GMP production processes
Cellevate caps strong 2025 by achieving ISO 9001:2015 certification and implementing GMP production processes in new cleanroom
LUND, Sweden – December 16, 2025 – Cellevate announces that it has achieved ISO 9001:2015 certification combined with GMP processes in cleanroom, marking a major milestone for Cellevate to becoming an industrial bioprocessing supplier.
The certification reflects Cellevate’s dedication to delivering the highest standard of quality assurance throughout all its processes, from the business plan and company management to research and development, production, sales and marketing, product delivery and customer support.
“Quality assurance is the responsibility of every Cellevate employee,” said Annika Andersson in charge of QA/RA at Cellevate. “Our mission has been from the start to bring to market cutting-edge, state-of-the-art products that truly meet the needs of our customers. In earning this certification, we are driven to not only adhere to our already high-quality assurance standards, but to continually improve upon them.”
In parallel with achieving ISO 9001 certification, Cellevate has completed and validated a new cleanroom at its facility in Lund. The cleanroom is dedicated to the production of the company’s commercial portfolio, Cellevat3d® nanofiber products, supporting the increasing demand from global distributors, biopharmaceutical companies, and CDMOs.
The cleanroom was designed and installed by Guardtech Cleanrooms (UK) using the modular ISOPOD construction platform. This cost-efficient approach enabled rapid installation while allowing the facility to be easily expanded or reconfigured as demand grows and commercial volumes increase. The cleanroom has been validated according to ISO 14644, ensuring compliance with international standards for air cleanliness, environmental control, and contamination management.
“Securing ISO 9001 certification is more than a quality milestone. It reflects our commitment to operational excellence and to supporting our customers with the highest level of reliability as we scale and intensify commercial operations,” said Laura Chirica, CEO at Cellevate. “Combined with the new cleanroom, we now have a robust and scalable foundation for expanding manufacturing capacity and implementing GMP-ready processes for commercial volumes. These new advancements strengthen Cellevate’s position as a trusted partner and supplier to customers and collaborators across the biopharmaceutical and bioprocessing industry.”
For more information, please contact:
Laura Chirica, PhD
CEO Cellevate
Email: laura.chirica@cellevate.com
About Cellevate
Cellevate is a Swedish biotech company based on proprietary nanofiber technology dedicated to building the next generation cell culture solutions for cell and gene therapy and novel vaccines biomanufacturing. The company is ISO 9001:2015 certified and has implemented GMP processes for production in clean room. The core nanotechnology, Cellevat3d® is a sustainable, deeptech innovation for the biopharmaceutical industry. This platform allows industrial-scale production of a new category of nanofiber cell culture systems – with unparalleled surface area for cell growth, reproducibility, customization, and scalability, which ultimately lead to increased yield, productivity and process economy. Cellevat3d® nanofiber-based products are designed and validated as an integrated part of upstream bioprocessing solutions, from laboratory to large-scale production.
For more information, please visit www.cellevate.com.