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Non Clinical Development

Following the early discovery and research phase, non-clinical development is carried out to further assess the safety and biological activity of the ATMP, before it is tested in humans. This includes laboratory studies in vivo and in vitro. These studies help researchers to understand how the treatment behaves in a biological system and identify any potential risks. A Clinical Trial Application (CTA) approval is needed before continuing this step into Clinical development.

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Emilie in Toronto – Summer by Design

Type: Resource

This June, Emilie Rickardsson Bergqvist participated in Summer by Design 2026 in Toronto, Canada, with support from SCALE. Emilie is a physician from Gothenburg specializing in Clinical Immunology and Transfusion Medicine.

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Thermo Fisher

Type: ATMP Company

Thermo Fisher Scientific is a global leader in life sciences, supporting research, biopharmaceutical development, and healthcare through innovative technologies, services, and laboratory solutions. In Gothenburg, the company is expanding its bioanalytical laboratory capabilities to support drug development through advanced testing and analysis services.

thermofisher.se

Simsen Diagnostics

Type: ATMP Company

Ultra-sensitive ctDNA monitoring for your clinical trial, your laboratory, your patients. Delivered as a service from our EU lab, or run on your own instruments.

simsendiagnostics.com

LanteRNA

Type: ATMP Company

Fluorescence based tools for RNA research Researching stealth labeling approaches and RNA analysis methods to support more representative RNA studies

lanterna.tech

Introduction to ATMPs

Type: Course

In this course you will get a basic introduction to advanced therapies (ATMPs) based on cells, genes or tissue material. You will also get concrete examples of cell, gene and tissue therapies, which include CAR-T therapies. The course also describes what Sahlgrenska University Hospital’s and Västra Götaland Region’s work looks like today regarding ATMP therapies, market-approved ATMPs and clinical trials.

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Good Manufacturing Practice (GMP) for ATMP – Theory

Type: Course

This training is intended for individuals who will be involved in the manufacturing or handling of Advanced Therapy Medicinal Products (ATMPs) within a GMP-regulated environment. The course provides an introduction to ATMPs and the regulatory frameworks governing this field, with a focus on Good Manufacturing Practice (GMP) for conventional medicinal products and GMP for ATMPs.

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AstraZeneca

Type: ATMP Company

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.

astrazeneca.se

Gothia Forum

Type: Support function

Clinical studies are essential for West Sweden to become a leading European life science cluster. We strengthen conditions for healthcare, academia, and industry to jointly develop tomorrow's treatments. Through professional research support, training, and clinical trial units, we enable research that reaches patients across the region. We are the Western healthcare region's node in Clinical Studies Sweden.

gothia-forum

Frank Liang

Type: Researcher

Focus on process development, manufacturing workflows, and quality-related aspects of ATMPs within Sahlgrenska university hospital. Previous and current projects relate to hospital-based manufacturing of tissue-engineered products and gene therapy medicinal products (CAR-T cells) and thereby, support the translation of advanced therapies into clinical practice.

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Cecilia Langenskiöld

Type: Researcher

Clinical activities focus on the application and implementation of advanced therapy medicinal products, including CAR-T cell therapies and virus-specific T-cell therapies. Work spans clinical studies, stem-cell transplantation, and the development of cellular immunotherapies for paediatric patients, contributing to the translation of emerging ATMP technologies into healthcare practice.

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Anders Lindahl

Type: Researcher

Research focuses on regenerative medicine and cell-based therapies for cartilage repair, with particular emphasis on the development of autologous chondrocyte transplantation and stem cell-based approaches using induced pluripotent stem cell (iPSC)-derived chondroprogenitors. Decades of experience in translating cartilage regeneration from laboratory research to clinical application have made this work an important example of ATMP development in orthopedics. Research activities are closely connected to GMP manufacturing capabilities and clinical studies aimed at advancing next-generation cell therapies for cartilage injuries and osteoarthritis.

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Laboratory methods for Advanced Therapy Medicinal Products (ATMP)

Type: Course

(BMA123) Ta chansen att lära dig mer om avancerade terapiläkemedel (ATMP). Kursen ger en introduktion till området och fokuserar på arbete enligt Good Manufactureing Practice (GMP) och kvalitetskontroll. Laboratoriemedicinska metoder som används för att säkerställa kvalitet, så som mikrobiologiska tester, tester av viabilitet med mera kommer går igenom. Kursen innehåller praktiska övningar och studiebesök. Föreläsningar på engelska kan förekomma.

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Utveckling och användning av cell‑ och genterapier (ATMP) och dess regelverk

Type: Course

(ATM800) I denna kurs kommer ni att få en bred kunskap inom nya behandlingsmetoder/läkemedel som ingår inom begreppet ATMP (Advanced Therapies and Medicin Products) genom föreläsningar av specialister inom respektive fält.

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Next-Generation Cell and Gene Therapies: Cancer and Beyond

Type: Course

The purpose of this course is to provide a comprehensive overview of next-generation cell and gene therapies and their potential to transform the treatment of cancer as well as other complex diseases. The participants will engage with the methods of cell and gene engineering through interactive toolbox sessions, facilitated in a flipped classroom format where students take the lead. Participants will gain an in-depth understanding of the principles and methods underlying cellular engineering, gene editing, and immunotherapy, while exploring how these technologies have evolved to address diverse medical challenges.

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Immune, Gene and Cell Therapy

Type: Course

(3MG018) The course gives an overview of new and established treatments based on immune, gene and cell therapy. The course will discuss new opportunities as well as difficulties with these kinds of therapies. Some areas that will be at focus are transplantation of endocrine cells, immunotherapy of cancer and stem cell transplantation. The course is a seminar series consisting of ten meetings. The seminars will be held by scientists and/or medical doctors in the field.

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Clinical Drug Development

Type: Course

(3KK005) This course provides you with a broad and deep knowledge of most stages in a drug's development from idea to the completed product. Special emphasis is placed on clinical trial methodology, where you will learn to plan a larger clinical trial. After completing the course, you should be able to work as a clinical trial associate or a similar position.

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Pharmaceutical Protein Drug Development

Type: Course

Through the course, you will understand how to develop a protein-based biological drug further after the initial proposed design of the drug.

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Regenerative Medicine

Type: Course

The course conveys the current knowledge, future potential use and development of regenerative medicine. Different stem cells, their biology and cellular programming are discussed, as well as tissue engineering, bioengineered cellular methods, next-generation biomaterials, and their applications in restoring damaged tissues and organs. Different stem cell therapies, cell and gene therapies, biobanking and in vitro differentiation of neural and myeloid stem cells will be illustrated.

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Nyctea Technologies

Type: ATMP Company

We're turning breakthrough materials innovations into cutting-edge purification solutions that transforms biomanufacturing.

Nycteatechnologies.com

Verigraft

Type: ATMP Company

VERIGRAFT uses a proprietary patent-protected technology to make donated tissue resemble the patient’s own. This personalized tissue is tailored to the patient and can be implanted without rejection.

verigraft.com

Fluicell

Type: ATMP Company

With the groundbreaking Nexocyte™ platform, based on twenty years of disruptive and patent-protected R&D, we are creating new ways to target serious diseases using precision-engineered biological tissues.

fluicell.com

Pretzel Therapeutics

Type: ATMP Company

Pretzel Therapeutics is advancing a new class of medicines that target cellular energetics at its source. By focusing on the mitochondria, we are unlocking novel pathways to treat disease and redefining what’s possible across areas of high unmet need.

pretzeltx.com

Ribocure Pharmaceuticals

Type: ATMP Company

Ribocure Pharmaceuticals AB (Ribocure) is a clinical stage biotech company based in Sweden, dedicated to advancing the field of cutting-edge RNA therapeutics.

Ribocure.com

Drug discovery and development

Type: Course

ATMP session is included in this course. The course in Drug Discovery and Development aims to give you an overall understanding of the discovery and development of novel pharmaceuticals (drug discovery/development). It covers target selection, lead discovery/optimization, non-clinical in vitro/in vivo safety and efficacy studies, clinical trials, and market authorization. The course also highlights examples of existing drugs, how they have been developed, and their mechanisms of action.

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Regenerative Medicine and the Immune Microenvironment: A Synergistic Approach

Type: Course

(H5F6071) This advanced doctoral course offers a deep dive into the dynamic interplay between regenerative medicine and the immune microenvironment. By integrating cutting-edge insights from immunology and cell therapy, the course equips students with the tools to understand how immune responses can enhance or hinder tissue regeneration.

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Gene, cell and immunotherapy

Type: Course

The course content is based on, and is a specialisation of, previous knowledge in biochemistry, cell and molecular biology from the undergraduate programme. The course is divided into three fields, cell-, gene- and immunotherapy. The course includes diverse subjects such as Good manufacturing practice (GMP), Advanced Therapy Medicinal Products (ATMP), both viral and non-viral gene therapy, gene editing, oligonucleotide- and mRNA treatments, genetically modified cells and antibodies that influence the immune system. Diagnostics methods connected to the treatments will also be discussed.

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From Research to ATMP Treatment – Process Development, Quality Assurance, Regulatory Affairs and Logistics

Type: Course

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.

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Lars Ny

Type: Researcher

Investigating tumor-infiltrating lymphocytes (TILs) as a personalized immunotherapy for patients with malignant melanoma. TILs are manufactured at the Cell and Tissue Laboratory, Sahlgrenska, and patients with ocular melanoma have received treatment in a completed Phase 1 HAITILs clinical trial. Process development is currently underway for the next clinical trial : Locoregional or Systemic Administration of Autologous Tumor Infiltrating Lymphocytes in Patients With Metastatic Melanoma (GoTIL-01), NCT07183852

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CCRM Nordic

Type: ATMP Company

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.

ccrmnordic.se

Regenerativ Medicin och avancerade terapier (ATMP)

Type: Course

(VMFP10) Är du redo att forma framtidens medicin? Utforska regenerativ medicin och avancerade terapier (ATMP) och få möjligheten att bidra till banbrytande medicinska framsteg. Denna kurs ger dig verktygen att omvandla forskning till kliniska tillämpningar och skapa en bättre framtid för våra patienter.

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Advanced AI for Biological Data

Type: Course

(BI765A) This course introduces advanced machine learning methods with applications in biology. Students will learn to apply and evaluate models on unimodal biological data and critically reflect on approaches for integrating multimodal datasets. The course also covers Explainable AI techniques, focusing on how to interpret and communicate complex model outputs in biological contexts through hands-on projects and real-world examples.

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Introduction to AI in bioinformatics

Type: Course

(BI763A) This course provides a introduction into the evolution and use of AI in biology, with a focus on machine learning techniques. Students will explore both supervised and unsupervised approaches, particularly deep learning, and learn when and how to apply them in biological contexts. Through hands-on programming, students will implement and evaluate AI models, while also developing critical skills for structuring and preparing data-driven analyses in life sciences.

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