SmartCella Holding AB
Nicolina Renkvist is a seasoned QA Manager with extensive experience in quality assurance for Advanced Therapeutic Medicinal Products (ATMPs). Currently serving at Procella Therapeutics AB since August 2022, Nicolina plays a key role in the construction and design of a new GMP facility and is a Subject Matter Expert in electronic Quality Management Systems. Prior to this, Nicolina held positions at ProPharma Group and CellProtect Nordic Pharmaceuticals, focusing on quality assurance, process optimization, and regulatory compliance for ATMPs, alongside participation in clinical trials aimed at treating Osteogenesis Imperfecta. Nicolina's expertise extends to cleanroom standards, quality management system design, and project management, drawing on a robust educational background that includes a PhD in Tumor Immunology and a postdoctoral fellowship in Cancer Immunology.
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SmartCella Holding AB
SmartCella, founded in 2014, is an innovative biotechnology company based in Stockholm, Sweden. SmartCella’s vision is to combine first-in-class delivery platforms with cutting-edge cell and gene therapies to unleash the full potential of targeted therapies. The company has three main business units, Smartwise, SmartCella Solutions and Procella. Smartwise is developing and manufacturing a first-in-class endovascular delivery device, the Extroducer, that enables direct tissue/organ infusions through the vessel wall directly into to hard-to-reach organs and tumors. There is a significant unmet need in the field of targeted delivery of different types of therapies for regeneration of tissue and for treatment of cancer tumors. Smartwise received regulatory approval from the US FDA for the Extroducer in June 2022 and is now actively out-licensing the technology to global companies with therapies that benefit from direct delivery. SmartCella Solutions create novel mRNA therapies and platforms that enable cell-mediated delivery of protein and mRNA to specific regions, even within organs or microenvironments. A pipeline of projects within regeneration and tolerization, focusing on oncology, is in pre-clinical development. Procella has advanced capabilities within stem cell therapy development and inhouse cGMP manufacturing of cell based therapies, with a proven platform to take stem cell projects from discovery phase to clinical development. A globally licensed cardiac stem cell therapy is entering clinical stages (in collaboration with AstraZeneca) and there is a growing pipeline of projects in different stages of development, with dopamine producing cells for Parkinson´s Disease and our own iMSCs most advanced.