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DTSTART:20260329T010000
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DTSTART;TZID=Europe/Stockholm:20260303T113000
DTEND;TZID=Europe/Stockholm:20260303T121500
DTSTAMP:20260417T044242
CREATED:20260205T215714Z
LAST-MODIFIED:20260205T215714Z
UID:10000222-1772537400-1772540100@kisciencepark.se
SUMMARY:BRIDGE Webinar: Regulatory Affairs for Biologics
DESCRIPTION:Regulatory Affairs for Biologics\n\n\n\nRegulatory strategy and CMC considerations are fundamental components of biological drug development and can significantly influence the transition from discovery to clinical development. Early alignment on these aspects is critical for de-risking development programs and ensuring regulatory readiness. \nIn this webinar\, Emma Eriksson and Marie Gårdmark from RegSmart Life Science will present key strategic regulatory elements in drug development. The presentation is divided into two parts: the first will address overarching regulatory strategy\, while the second will focus on selected CMC aspects specific to biological drug development. \n\nREGISTER HERE \nABOUT BRIDGE \nRunning for 3 years and supported by SweLife through the Swedish Innovation Agency\, Vinnova\, BRIDGE aims to create a development platform spanning from identifying drug candidates to production.  Project start: 2024. \nPROJECT PARTNERS \nTesta Center (Project Coordinator): A national “open access” laboratory and production environment for academics and companies looking to verify and upscale their biological process for large-scale production. \nSciLifeLab Drug Discovery and Development Platform (DDD): A national research infrastructure providing state-of-the-art technology and expertise in drug development\, from small molecules\, biological pharmaceuticals\, therapeutic oligonucleotides\, and new modalities\, from concept to preclinical stage. \nStem Cell Center & Pre-GMP Lund University (LU): Conducting research in cell\, tissue\, and gene therapy\, and supporting researchers with pre-GMP services to bridge the gap from research findings to patient care. These units also closely collaborate with the ATMP center (SUS)\, a node for Region Skåne’s work with ATMP treatments. \nSTUNS: Foundation for collaboration between universities in Uppsala\, industry\, and society\, promoting co-creation at the intersection of universities\, industry\, and society to create new opportunities. \nALIS (Association of Life Science Incubators): A national platform that brings together nine regional life science incubators (GU Ventures\, KI Innovations\, Lead\, Medeon\, Sahlgrenska Science Park\, Smile Incubator\, STING\, Umeå Biotech Incubator och Uppsala Innovation Center) tasked with supporting and guiding startups and research groups in skills development\, business development\, coaching\, and access to national and international private capital
URL:https://kisciencepark.se/event/bridge-webinar-regulatory-affairs-for-biologics/
LOCATION:Webinar: Microsoft teams
ATTACH;FMTTYPE=image/jpeg:https://kisciencepark.se/wp-content/uploads/2026/02/260303-bridge-webinar.jpg
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20260127T113000
DTEND;TZID=Europe/Stockholm:20260127T121500
DTSTAMP:20260417T044242
CREATED:20260108T202248Z
LAST-MODIFIED:20260108T202357Z
UID:10000207-1769513400-1769516100@kisciencepark.se
SUMMARY:BRIDGE Webinar: Cell Line Development
DESCRIPTION:How to bridge the gap from research to commercialization\nCell line development is a crucial step in taking biologics from discovery to the clinic and often represents the first major hurdle in the “valley of death.” The SciLifeLab Drug Discovery and Development platform now includes a Cell Line Development facility that will help bridge the gap to the clinic for early-stage projects. \nIn this webinar\, Niklas Berndt Thalén from SciLifeLab will present the cell line development process\, explain why this step is essential for generating clinical-grade material\, and outline what the new facility at DDD can offer. \nREGISTER HERE \nThe Bridge webinar series is aimed at researchers\, start-up and scale-up companies\, as well as organisations within the innovation support system engaged in the development of biological products and pharmaceuticals. \nDon’t miss this opportunity to learn how to bridge the gap from research to commercialization. \n\nABOUT BRIDGE \nRunning for 3 years and supported by SweLife through the Swedish Innovation Agency\, Vinnova\, BRIDGE aims to create a development platform spanning from identifying drug candidates to production.  Project start: 2024. \nPROJECT PARTNERS \nTesta Center (Project Coordinator): A national “open access” laboratory and production environment for academics and companies looking to verify and upscale their biological process for large-scale production. \nSciLifeLab Drug Discovery and Development Platform (DDD): A national research infrastructure providing state-of-the-art technology and expertise in drug development\, from small molecules\, biological pharmaceuticals\, therapeutic oligonucleotides\, and new modalities\, from concept to preclinical stage. \nStem Cell Center & Pre-GMP Lund University (LU): Conducting research in cell\, tissue\, and gene therapy\, and supporting researchers with pre-GMP services to bridge the gap from research findings to patient care. These units also closely collaborate with the ATMP center (SUS)\, a node for Region Skåne’s work with ATMP treatments. \nSTUNS: Foundation for collaboration between universities in Uppsala\, industry\, and society\, promoting co-creation at the intersection of universities\, industry\, and society to create new opportunities. \nALIS (Association of Life Science Incubators): A national platform that brings together nine regional life science incubators (GU Ventures\, KI Innovations\, Lead\, Medeon\, Sahlgrenska Science Park\, Smile Incubator\, STING\, Umeå Biotech Incubator och Uppsala Innovation Center) tasked with supporting and guiding startups and research groups in skills development\, business development\, coaching\, and access to national and international private capital
URL:https://kisciencepark.se/event/bridge-webinar-cell-line-development/
LOCATION:Webinar
ATTACH;FMTTYPE=image/jpeg:https://kisciencepark.se/wp-content/uploads/2026/01/260117-bridge-cell-line.jpg
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