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

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Bioengineering is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

• Stem cell bioprocessing 
• Bioprocesses for CAR-T cells 
• Gene therapy vector process development 
• Oncolytic virus production 
• Processes for combined ATMPs 
• Online monitoring 
• Bioreactor processes/concepts 
• Downstream procedures