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European Biopharmaceutical Review

Exploring Amino Acid-Based and Stable Spray-Dried Vaccines

The development of therapeutic biologics (including vaccines) requires significant efforts to avoid severe issues due to molecular instability. In a recently published survey, several key findings were discussed, including formulation issues, project failures, and solutions to overcome such hurdles (1). One key finding was that formulation issues cause significant drug development delays and even complete project failures due to formulation issues, as experienced by more than 60% and 6% of survey participants, respectively. Consequently, deploying a commercially viable formulation early enough in the drug product development process could help to prevent failure of such projects.

Furthermore, competitive advantages and reduced time to market are key decision criteria in formulation development, and aspects on reduced manufacturing costs, longer shelf life, and facilitated transport, as well as logistics, were considered as important aspects of formulation (1). Within the vaccine market, the need for cold storage and the impossibility of terminal sterilisation are major drawbacks in vaccine manufacturing and distribution, particularly in the case of spray-dried vaccines. Hence, facilitated transportation at room temperature and terminal sterilisation of vaccines would result in clear competitive advantages.

Molecular Damage During Manufacturing of Vaccines

Today, major challenges in the field of vaccination are to develop thermostable vaccines and to establish needlefree vaccination strategies to fight viral diseases, even in developing countries, which is also one strategic aim of the WHO Global Immunization Vision and Strategy (2-3). Furthermore, to be better prepared for pandemic outbreaks, stockpiles of stable vaccine formulations are required (4).

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Dr Jens Altrichter is a Medical Doctor and Biochemist. Researcher periods took him to various US competence centres. In 1998, Jens left his research and teaching position at the University of Rostock, Germany, and founded biotechnology company CellTech, where he became CEO. In 2006, Jens joined LEUKOCARE as Managing Director, and, in 2012, he became Chief Operating Officer, adopting responsibilities for R&D, production management, and regulatory affairs. In 2017, he co-founded ARTCLINE and became CEO at the company.

Dr Kristina Kemter works as a Project Leader in R&D at LEUKOCARE. In her current position, Kristina is responsible for continuous development of LEUKOCARE’s proprietary Stabilizing and Protecting Solutions (SPS®) formulation platform. Between 2005-2010, Kristina worked in a postdoctoral fellowship and as Project Leader at the Department of Molecular Pediatrics, Dr von Hauner Children’s Hospital, Ludwigs Maximilians University, Germany. Kristina also worked in a postdoctoral fellowship and studied chemistry with a focus on biochemistry at the Technical University Munich, Germany, at the Chair of Biochemistry.

Rebekka Ströver studied translation studies at the University of Heidelberg, Germany, specialising in Spanish and English language, and medical translations. Rebekka held various positions in the field of medical translations in pharma and biotech. She joined LEUKOCARE in 2016 and is now part of the marketing and sales team serving as communication and marketing specialist.

Professor Dr Martin Scholz studied biology in Frankfurt am Main, Germany, and specialised in experimental medicine, immunology, and virology. Martin is associated with the Heinrich Heine University Hospital in Düsseldorf, Germany, as an APL Professor, where he was Head of Research in the Department of Traumatology between 2005-2010. Martin founded LEUKOCARE in 2001, where he worked as Chief Scientific Officer until the end of 2017. He wrote a large number of scientific publications and patent applications in the field of stabilisation of biologics. As a consultant, Martin currently supports LEUKOCARE and biotech start-up companies.
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Dr Jens Altrichter
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Dr Kristina Kemter
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Rebekka Ströver
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Professor Dr Martin Scholz
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