Production, analytics & regulatory aspects of advanced therapy medicinal products
In this century, development of Advanced Therapy Medicinal Products (ATMP), including gene therapeutics and human cell therapeutics, has been envisioned as ‘the’ beneficial breakthrough of molecular cell biology, capable of significantly advancing human health in the near future.Under biomedical and social scrutiny, this innovative medical approach certainly has evolved into a highly hoped-for revolutionary cure of a broad spectrum of inherited and acquired human diseases, ranging from cancer to heart disease and immunological disorders.
The challenges and issues of manufacturing and analytics of human cell therapeutics are very different from all existing therapeutics, including biopharmaceuticals, and a key factor of their success is the management of multiple challenges addressing safety, purity and potency of these highly-engineered cell products. Robust and reliable manufacturing processes of target cells, manipulated ex vivo prior to administration to the patient, present the most challenging issue. Efficient gene transfer vectors, delivering the therapeutic gene into a broad spectrum of cells without causing any associated pathogenic effect, need to be developed for these purposes. 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. Therefore, cell therapy analytics needs to be adapted to this broad range of complex manufacturing processes ensuring adequate safety, purity and potency of the final products.
This conference will highlight the new challenging field of cell and gene therapeutic approaches, which are based on cells, plasmids and vectors. Advances in cultivation and manufacturing and control methods will be presented.
The Scientific Committee cordially invites you to this event and looks forward to lively interactions and discussions on the newest topics of the field.
Bildquelle: X. Wu
DECHEMA-Fokus-Themen:
