Cellevate has announced that it has achieved ISO 9001:2015 certification combined with GMP processes in cleanroom, marking a major milestone for Cellevate to become 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."
Alongside the ISO 9001 certification achievement, 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."