Publications

Formulation of adeno-associated viral (AAV) vectors requires analytical methods that are predictive of stability, use minimal material, and allow high-throughput testing—criteria that are often difficult to meet. This exploratory study assessed several analytical techniques for their ability to predict or indicate AAV stability. Two methods emerged as particularly promising: extrinsic differential scanning fluorimetry with SYBR Gold for genome release detection, and nano differential scanning fluorimetry for capsid stability. Size-exclusion chromatography with multi-angle light scattering and UV was also effective for monitoring particle size and genome load.

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Formulating protein biopharmaceuticals is increasingly complex due to new modalities and high concentration needs, with limited excipient testing possible in the lab. To address this, we developed ExPreSo, a machine learning tool that predicts suitable excipients based on protein properties and product profiles. Trained on 350+ stable formulations, ExPreSo uses features like structural data and sequence embeddings to suggest excipients with high accuracy and minimal overfitting. Even sequence-only models performed well, highlighting robustness. This is the first ML tool of its kind and offers a faster, more efficient approach to excipient screening.

ArchPharm 2023 Aug;356(8):e2300101
ABDEL-TAWAB M. ET AL: An exploratory study on the effect of mechanical stress on particle formation in monoclonal antibody infusions

”A Specialist in Bioinformatics based Stabilization of All kinds of Biological Molecules". ISSN 2831-8331

JHEP Reports. 2023 Feb; 5(2): 100603
SACHERL J. ET AL: Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance

F. Thomas,” Pharmaceutical Technology Europe 33 (4) 2021.

pharmtech.com/view/focusing-on-accelerated-formulation-strategies

S. Smith,” Liquid formulation bolstered by AI". ISSN 2644-2787

Journal of Pharmaceutical Sciences 109 (2020) 818-829
REINAUER E. ET AL: Algorithm-Based Liquid Formulation Development Including a DoE Concept Predicts Long-Term Viral Vector Stability

Rentschler Biopharma SE/ Leukocare AG: Contract Pharma_54-58 Advertorial 1020
BHONSLE-DEENG L. and PETROPOULOS K.: Advanced Formulation Development by Design in the Context of Holistic Drug Production

European Biopharmaceutical Review January 2019, pages 28-36. © Samedan Ltd
ALTRICHTER J. ET AL: Exploring Amino Acid- Based and Stable Spray- Dried Vaccinations

Biotechnol. J. 2018, 13, 1700523
SCHOLZ M. ET AL.:Amino acid-based advanced liquid formulation development for highly concentrated therapeutic antibodies balances physical and chemical stability and low viscosity

European Biotechnology | Autumn Edition | Vol. 17 | 2018
"Formulation matters": Interview with LEUKOCARE´s CEO Michael Scholl about the impact of formulation on drug product performance.

Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
"2018 Survey- Formulation in the Drug Product Development Process": 2018 Survey ‘Formulation in the Drug Product Development Process’, based on research from Informa Pharma Intelligence

2014 April; Vol. 32, Issue 19
SCHERLIESS R. ET AL.: Induction of protective immunity against H1N1 influenza A(H1N1)pdm09 with spray-dried and electron-beam sterilised vaccines in non-human primates

2014 July; Vol. 10, Issue 10, Meeting Report
DERWAND R.: Annual World Vaccine Congress 2014: A re-evaluation of the value proposition for increasing vaccine thermostability

2014 December, PLoS ONE 9(12): e115940. doi:10.1371/journal.pone.
WINDOLF C.D. ET AL.:Lysostaphin-Coated Titan-Implants Preventing Localized Osteitis by Staphyloccus aureus in a Mouse Model

2012 March; Vol. 7, Issue 8
SCHOLZ M. and LÜKING A.: A protein-stabilizing technology for enhanced antibody stability and antibody-binding profiles in a microchip array

2012 September; Vol. 15, Number 9
TSCHELIESSNIG R. ET AL.: Nano-coating protects biofunctional materials

2011 Mar; 216(3): 334-42
PAUNEL-GOERGUELUE A. ET AL.: Stimulation of Fas signaling down-regulates activity of neutrophils from major trauma patients with SIRS

2010 Apr; 20(7): 18
LÖGTERS T. ET AL.: Extracorporeal immune therapy with immobilized agionistic anti-Fas antibodies leads to transient reduction of circulating neutrophil numbers and limits tissue damage after hemorrhagic shock/resuscitation in a porcine model

2009 Nov; 27(11): 1401-7
LÖGTERS T. ET AL.: Diagnostic accuracy of neutrophil-derived circulating free DNA (cf-DNA/NETs) for septic arthritis

2009 Jul; 32(1): 29-34
LÖGTERS T. ET AL.: Increased plasma kynurenine values and kynurenine: tryptophan ratios after major trauma are early indicators for the development of sepsis

2009-nov-198(4)-211-9-lögters-t-et-al-the-clinical-value-of-extracellular-traps

2009 Nov; 15: 183(10): 6198-6206
PAUNEL-GOERGUELUE A. ET AL.: McI-1-mediated impairment of the intrinsic apoptosis pathway in circulating neutrophils from critically ill patients can be overcome by Fas stimulation

2008 Oct; 30 (4): 352-8
MARGRAF S. ET AL.: Neutrophil-derived circulating free DNA (cf-DNA/NETs): a potential prognostic marker for posttraumatic development of inflammatory second hit and sepsi

2007 May; 27(3): 401-16
SCHOLZ M. ET AL.: Neutrophils and the blood-brain barrier dysfunction after trauma

2007 Oct; 4:21
ABDEL-RAHMAN U. ET AL.: Inhibition of neutrophil activity improves cardiac function after cardiopulmonary bypass

2005 Mar-Apr; 51(2): 144-7
SCHOLZ M. ET AL.: First efficacy and safety results with the antibody containing leukocyte inhibition module in cardiac surgery patients with neutrophil hyperactivity

2005 Apr 8; 329(2): 616-23
SCHULLER AM. ET AL.: Degradation of microvascular brain endothelial cell beta-catenin after co-culture with activated neutrophils from patients undergoing cardiac surgery with prolonged cardiopulmonary bypass

2005 May; 25(3): 331-42
SCHOLZ M. ET AL.: Fas/FasL interaction: a novel immune therapy approach with immobilized biologicals

2004 Jan; 19(1): 11-6
MORENO JB. ET AL.: Inhibition of neutrophil activity in cardiac surgery with cardiopulmonary bypass: a novel strategy with the leukocyte inhibition module

2004 Jun; 127(6): 1735-42
SCHOLZ M. ET AL.: In vivo inhibition of neutrophil activity by a FAS (CD95) stimulating module: arterial in-line application in a porcine cardiac surgery model