Fraunhofer Sputum Core Facility

Fraunhofer ITEM's sputum center

Custom-tailored study design for your sputum analysis

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Our experienced sputum center offers centralized organization and analysis to achieve optimal results for sputum analysis in multicenter clinical trials.

We guarantee the best choice of sputum methodology to meet the requirements of a particular trial. Furthermore, we offer study-specific training for our clients, supervision of quality during study conduct, and analysis of a broad spectrum of biomarkers.

Our services

Specific sputum biomarkers
© Fraunhofer ITEM, Felix Schmitt
We assist you in the selection of specific sputum biomarkers.
  • Scientific consultancy for optimal study design
  • Assistance in sputum biomarker selection
  • Study-specific sputum method setup
  • Preparation of study-specific lab manual / SOPs
  • On-site or centralized sputum training workshops for participating sites
  • Continued quality check of samples
  • Data report/publication
  • Sample shipment and storage
  • Centralized sputum analysis
    • Cellular sputum composition (incl. FACS)
    • Sputum fluid-phase biomarkers (ELISA, MSD)
    • Chip cytometry
    • Gene expression
    • Metabolomics (BIOKRATES)

Track Record and equipment

Comprehensive experience with client-specific sputum protocols

GCP compliance

To guarantee that the work performed at Fraunhofer ITEM satisfies internationally accepted quality standards, Fraunhofer ITEM has implemented the GXP quality assurance systems.

Scientific staff with many years of experience

  • Over 30 papers and reviews on methods of sputum analysis and their use
  • Consultancy to pharmaceutical industry in non-invasive airway monitoring
  • Member of the sputum taskforce
  • Training for multicenter trials involving sputum analyses since 2001

Sputum induction and processing according to SOPs

Experienced team of study nurses and technical staff

  • Numerous clinical trials with sputum analysis
  • Routine performance of sputum induction

Method development and validation of new biomarkers incl. chip cytometry

Literature

Pedersen F, Trinkmann F, Abdo M , Kirsten AM, Rabe KF, Watz H, Baraldo S, Saetta M, Hohlfeld JM,  Holz O. Influence of Cell Quality on Inflammatory Biomarkers in COPD Sputum Supernatant. Int J Chron Obstruct Pulmon Dis. 2021;16:487-493, https://doi.org/10.2147/COPD.S284938

Kern AL, Biller H, Klimeš F, Voskrebenzev A, Gutberlet M, Renne J, Müller MHolz O, Wacker F, Hohlfeld JM, Vogel-Claussen J. Noninvasive Monitoring of the Response of Human Lungs to Low-Dose Lipopolysaccharide Inhalation Challenge Using MRI: A Feasibility Study. J Magn Reson Imaging. 2020 Jun; 51 (6): 1669-1676. doi: 10.1002/jmri.27000. Epub 2019 Nov 15. PMID: 31729119

Pedersen F, Zissler UM, Watz H, Rabe KF, Hohlfeld JMHolz O. Rating sputum cell quality in clinical trials for asthma and COPD treatment. Int. Journal of COPD, 2019

Holz O, Biller H, Mueller M, Kane K, Rosano M, Hanrahan J, Hava DL, Hohlfeld JM. Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model—a clinical trial. BMC Pharmacol Toxicol. 2015

Janssen O, Schaumann F, Holz O, Lavae-Mokhtari B, Welker L, Winkler C, Biller H, Krug N, Hohlfeld JM. Low-dose endotoxin inhalation in healthy volunteers—a challenge model for early clinical drug development. BMC Pulm Med. 2013

Röpcke S, Holz O, Lauer G, Müller M, Rittinghausen S, Ernst P, Lahu G, Elmlinger M, Krug N, Hohlfeld JM. Repeatability of and relationship between potential COPD biomarkers in bronchoalveolar lavage, bronchial biopsies, serum, and induced sputum. PLoS One. 2012; 7 (10)

Biller H, Holz O, Windt H, Koch W, Müller M, Jörres RA, Krug N, Hohlfeld JM. Breath profiles by electronic nose correlate with systemic markers but not ozone response. Respir Med. 2011

Holz O, Khalilieh S, Ludwig-Sengpiel A, Watz H, Stryszak P, Soni P, Tsai M, Sadeh J, Magnussen H. SCH527123, a novel CXCR2 antagonist, inhibits ozone-induced neutrophilia in healthy subjects. Eur Respir J. 2010

Holz O, Tal-Singer R, Kanniess F, Simpson KJ, Gibson A, Vessey RS, Janicki S, Magnussen H, Jörres RA, Richter K. Validation of the human ozone challenge model as a tool for assessing anti-inflammatory drugs in early development. J Clin Pharmacol. 2005 May; 45 (5): 498-503. PubMed PMID: 15831772

Holz O, Mücke M, Paasch K, Böhme S, Timm P, Richter K, Magnussen H, Jörres RA. Repeated ozone exposures enhance bronchial allergen responses in subjects with rhinitis or asthma. Clin Exp Allergy. 2002

Paggiaro PL, Chanez P, Holz O, Ind PW, Djukanović R, Maestrelli P, Sterk PJ. Sputum induction. Eur Respir J Suppl. 2002

 

Fraunhofer ITEM 

Contact

Meike Müller

Contact Press / Media

Dr. Meike Müller

Head of Department of Biomarker Analysis and Development

Phone +49 511 5350-8144