In recent years, the development of Advanced Therapy Medicinal Products (ATMP), including gene and cell-based therapeutics, has been envisioned as ‘the’ beneficial breakthrough of molecular cell biology, capable of addressing many unmet medical needs. With a number of newly approved therapeutic products and more than 1000 clinical trials worldwide, this innovative medical approach has evolved into a highly hoped-for revolutionary cure of a broad spectrum of inherited and acquired human diseases, ranging from cancer to immunological disorders and rare diseases.
The challenges and issues of manufacturing and analytics of gene and cell therapeutics are very different from all other therapeutics, including biopharmaceuticals. A key factor of success is the management of multiple challenges addressing safety, purity and potency of these advanced therapies. Robust and reliable manufacturing processes are still far from routine. Efficient gene transfer vectors, delivering the therapeutic gene into the target cells without causing any associated pathogenic effect, need to be developed and produced in large-scale. Depending on the complexity and individuality of this product class, cell therapy manufacturing processes may comprise consistent procedures of culture, expansion, genetic manipulation, stimulation, and in case of treatments of multiple patients, cell banking. Analytics and quality control need to be adapted to this broad range of complex manufacturing processes ensuring adequate safety, purity and potency of the final products.
The conference will highlight the challenging field of gene and cell therapeutic approaches. Advances in development and manufacturing will be presented, as well as quality control methods and regulatory aspects: The focus is on the path to safe and beneficial advanced therapies for the patient.
The Scientific Committee cordially invites you to this event and looks forward to lively interactions and discussions on the newest topics of the field.
The conference is an initiative of the DECHEMA working groups Cell Culture Technology and Medical Biotechnology.
|Ulf Bethke||Miltenyi Biotec GmbH, Bergisch Gladbach|
|Cornelia Kasper||University of Natural Resources and Life Sciences, Vienna|
|Konrad Kohler||BioMedTech, Forschungscampus Reutlingen|
|Thomas Noll||University of Bielefeld|
|Ralf Pörtner||Technical University Hamburg|
|Bernd Schröder||Miltenyi Biotec GmbH, Teterow|
|Karin Tiemann||DECHEMA e.V. Frankfurt am Main|
|Andrea Traube||OPTIMA pharma GmbH, Schwäbisch Hall|
|Roland Wagner||Technical University Braunschweig|
Mehr Informationen: Committee