Bioprocess Engineering for Advanced Therapeutic Medicinal Products (ATMPs)

Dear Colleagues,

Over the past decade, the research and development of advanced therapeutic medicinal products (ATMP) has increased. ATMPs contain gene therapeutics, e.g., genetically modified viruses, oncolytic viruses or CAR-T cells, somatic cell therapeutics, e.g., stem cell products, and tissue engineered products or combinations of those. Big hopes are connected with ATMPs in multiple areas, such as cancer, hereditary diseases or regenerative medicine. Not only is the development of such therapeutics challenging, but manufacturing must also take into account the complexity and individuality of those products. Since 2012, ATMPs and their manufacturing have been strongly regulated under the guidance of authorities such as EMA and FDA. If an ATMP is ready for clinical trials (IND-stage) and enters first-in-human studies, the impact of manufacturing and production processes increases.

This Special issue invites contributions on the process development of ATMPs. The scope covers theoretical and practical investigation of ATMP bioprocessing either in up- or downstream process development. As vaccines are not considered as ATMPs, papers related to vaccine process development are not within the scope of this issue.

This Special Issue is open for comprehensive review and original research papers and addresses the following topics:

• Up- and downstream development for ATMPs, including adaption of existing processes and process intensification;
• Manufacturing challenges;
• Theoretical process set-up (bioengineering calculations, CFD simulations);
• Novel bioreactor systems;
• Innovative downstream strategies;
• Online monitoring tools and process automation;
• Solution for major technical bottlenecks related to ATMP bioprocessing.

I look forward to your contributions and all the efforts taken in the process development and the manufacturing of advanced therapeutic medicinal products.

Dr. Denise Salzig
Guest Editor

Manuscript Submission Information

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