The stem cell company NextCell invests in own production facility
The stem cell company NextCell Pharma AB (“NextCell” or “the Company”) announces today that they have entered into an agreement with the property manager Hemsö and the clean room supplier QleanAir, to build a full-scale production facility. This new production facility will be directly connected to the Company's existing office and clean room in the Novum building, next to Karolinska University Hospital in Huddinge. The construction will take place later this spring and the premises are expected to be completed during the third quarter of 2021.
The significant upcomming medical need for cellular therapeutics for diabetes and autoimmune diseases requires optimized large-scale production with locations in several manufacturing facilities. The production of NextCell's drug candidate ProTrans has from start been outsourced to PBKM FamiCord Group, also a strategic partner and shareholder in NextCell. By expanding the existing production capacity with its own GMP facility, NextCell further develops the manufacturing process from 2-dimensional cell culture to a 3-dimensional bioreactor in accordance with the Eurostars Horizon 2020 grant of SEK 5 million. NextCell’s establishment of the new full-scale GMP facility is key in the bioreactor manufacturing process development as the primary purpose of the GMP facility is to prepare technology transfer to a potential partner or additional contract manufacturer in addition to the PBKM FamiCord Group.
We have made tremendous progress and it is time to consolidate the selection algorithm and the manufacturing process. Prior to market approval, we must ensure the availability of ProTrans. With its own GMP facility, NextCell is taking the first step towards securing future production on a commercial scale”, says Mathias Svahn, CEO of NextCell.
NextCell already has D-class clean rooms, a permit to operate a tissue establishment, a biobank with a primary sample collection and a wholesale permit in accordance with GDP issued by IVO and the Medical Products Agency. The new premises will house GMP-certified B-class cleanrooms and a QC laboratory that can be used for process development and ProTrans production, after the usual permit testing by the Swedish Medical Product Agency.
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For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Sofia Fredrikson, CFO
Phone: 08-735 5595
About NextCell Pharma AB
NextCell is a Phase II cell therapy company with the lead candidate ProTrans™, for the treatment of type-1 diabetes. Focus is to take ProTrans™ to market approval via a phase III study. Furthermore, NextCell operates Cellaviva, Scandinavia's largest stem cell bank for family-saving of stem cells from umbilical cord blood and umbilical cord tissue with permission from IVO.
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