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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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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

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

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

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

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

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

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

Journal of Pharmaceutical Sciences 109 (2020) 818-829
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European Biopharmaceutical Review January 2019, pages 28-36. © Samedan Ltd
ALTRICHTER J. ET AL: Exploring Amino Acid- Based and Stable Spray- Dried Vaccinations

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

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.

Biotechnol. J. 2018, 13, 1700523
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2014 July; Vol. 10, Issue 10, Meeting Report
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2012 March; Vol. 7, Issue 8
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2010 Apr; 20(7): 18
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2007 Oct; 4:21
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2004 Jan; 19(1): 11-6
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