Quality Assurance
Quality Assurance underpins the entire ATMP development journey by ensuring that quality systems, processes, and documentation are established and maintained throughout the product lifecycle. QA supports compliance with regulatory requirements, promotes traceability and data integrity, and helps manage risks associated with development and manufacturing. As the therapy advances toward clinical use, approval, and market access, quality oversight becomes increasingly critical to ensuring patient safety and product reliability.
Vera CQ
Vera CQ is founded by colleagues who enjoy working together, every day. With a joyful, collaborative and solution-oriented approach, we provide expert support in GxP, training and audits, across the life science field.
Getinge
Getinge is a global medtech company providing advanced manufacturing, cleanroom, and aseptic processing solutions that support the development and production of ATMPs, including cell and gene therapies.
ATMP, läkemedel för avancerade terapier
European Patients' Academy for Therapeutic Innovation Sverige erbjuder en gratis och webbaserad utbildning för dig som är patient, företrädare eller närstående. Här lär du dig mer om forskning och utveckling av läkemedel och medicinteknik. Du går utbildningen när det passar dig och behöver inte känna någon tidspress. Du får god kunskap om forskning och utveckling av läkemedel och medicinteknik, biobankning, precisionsmedicin, regulatoriska frågor, samt hälsoekonomiska prövningar och samverkansetik.
AstraZeneca
AstraZeneca is global pharma company with strong connection to Sweden through both big research and manufacturing sites. Their development of ATMPs includes CAR-T and TCR-T treatments, as well as drug delivery platforms. Their research as well as product development is spread out globally with over 80 000 employees over the world.
PRECISION bioanalytics
PRECISION bioanalytics (PBA) is a Swedish life science company developing patented sample preparation and molecular analysis technologies that significantly improve the sensitivity of nucleic acid detection. Our solutions support ATMPs, by enabling more sensitive analysis of DNA, RNA, mRNA, and other low-abundance biomarkers within existing laboratory workflows.
From Research to ATMP Treatment – Process Development, Quality Assurance, Regulatory Affairs and Logistics
Take your expertise to the next level with this cutting-edge course in cell and gene therapy (ATMP) development and production. Gain a deep understanding of every step in the process, from designing and implementing standard operating procedures (SOPs) to ensuring product purity and function. Learn how to navigate the transition from pre-GMP to GMP, understand key regulatory requirements, and explore the legal landscape of ATMP products.
CCRM Nordic
CCRM Nordic, based in Gothenburg, Sweden, supports academic, small, and large industrial ATMP developers to translate research and early-stage clinical programs into treatments for patients.