Krems Bioanalytics

Full bioanalytical service with global reach

Our services

One-stop bioanalytics

Tailor-made solutions and quality assured service to accelerate your drug development program

Consultancy

High-level scientific support and risk assessments for strategic decisions

Partnerships

Collaborations create synergies to realize your scientific aims rapidly and cost-effectively

Krems Bioanalytics

Full bioanalytical service with global reach

Our services

One-stop bioanalytics

Tailor-made solutions and quality assured service to accelerate your drug development program

Consultancy

High-level scientific support and risk assessments for strategic decisions

Partnerships

Collaborations create synergies to realize your scientific aims rapidly and cost-effectively

Krems Bioanalytics

Full bioanalytical service with global reach

Our services

One-stop bioanalytics

Tailor-made solutions and quality assured service to accelerate your drug development program

Consultancy

High-level scientific support and risk assessments for strategic decisions

Partnerships

Collaborations create synergies to realize your scientific aims rapidly and cost-effectively

Company

About us

Krems Bioanalytics is the contract research institute of the IMC University of Applied Sciences Krems. We are located at the Technology and Research Center in Krems, one of the technology oriented business clusters in Austria. The Biotech Area Krems encompasses three universities and numerous companies specializing in biomedical sciences.

The research institute provides contract research for industry and academia institutions since 2014. We specialize in innovative bioanalytical services for large molecules with strong expertise in customized immunogenicity assessments, including method development, GLP compliant assay validation and sample analytics for research and clinical trials.

Our in-depth scientific expertise and established cutting-edge technologies makes us your competent partner in drug development.

customized validated assays exceeded

APPROVED BIOTHERAPEUTICS SUPPORTED

Preclinical & GLP STUDIES EXCEEDED

CLINICAL STUDIES SUPPORTED

Mission

We strive to provide the highest level of service to benefit our customers and the health of patients.

Our commitment and scientific know how makes the difference to your drug development program.

 

  • Advance your study and drug development program as one-stop bioanalytical service provider.

  • Create robust data through full regulatory compliance.

  • Establish strategic partnerships for innovative research and state of the art sample analytics.

 

Management Team

Innovation minded – Results driven – Goal oriented

Our interdisciplinary team has in depth expertise in R&D of biopharmaceuticals, analytical method development, routine sample analysis for preclinical and clinical development, good laboratory/manufacturing/clinical practice (GLP/GMP/GCP) and quality assurance (QA). Contact us to discuss how we can support your program!

Andreas EGER

Andreas EGER

Head of Institute / Test Facility Management

Frank HORLING

Frank HORLING

Co-Head of Institute / Test Facility Management

Peter ALLACHER

Peter ALLACHER

Head of Bioanalytics / Study Director

Christian LUBICH

Christian LUBICH

Head of Immune Monitoring / Study Director

Verena WIESER

Verena WIESER

Head of GLP Quality Assurance

Competencies

Scientific expertise beyond bioanalytical routine

Core expertise

Experience is fundamental – quality is pivotal

With our comprehensive scientific expertise in immunology, hematology and cancer research, we are your competent one-stop service provider in routine and advanced bioanalytics.

Our competencies for customized assay development and validation ensure you saving time and money in your drug development programs. We meet the highest regulatory requirements for GLP and GCLP and industrial ISO standards.

Innovation makes the difference

  • Fully established unique and versatile platform for immunogenicity testing in hemophilia
  • Qualified affinity platform to characterize clinically relevant anti-drug antibodies
  • Innovative flow-cytometry-based approaches for biotherapeutic product characterization
  • Immune monitoring for clinical and preclinical research
  • Organotypic disease modelling for drug testing

Services

Tailored solutions for your requirements

Assay design

Assay validation

Data generation

Data interpretation

Risk assessments

One-stop bioanalytics

We offer a wide range of advanced bioanalytical services for large molecules and we develop tailored solutions for your specific drug development program. Our experts will work with you from assay design, development or transfer and validation to routine sample management and testing. We are working with you on customized or kit-based methods to quantify analytes cost effectively in animal (e.g. mouse, rat, rabbit, rhesus/cynomolgus monkey) or human (healthy and diseased) matrices. Our laboratories are certified for GLP and GCLP by the Austrian Agency for Health and Food Safety and for relevant industrial standards (ISO) by Quality Austria. In addition, industrial customers regularly audit our quality systems.

As one stop service provider, we cover all relevant bioanalytical fields in drug development.

Bioanalytics for hematologic and immunologic disorders are one example of our current core activities. For specialized research applications, our customers gain access to a comprehensive analytical platform including standard assays and advanced bioanalytical tools.

Rely on our scientific support to go beyond the routine and approach the technically possible to safeguard your investments.

Pharmacokinetics &-dynamics
  • drug level quantification
  • drug activity analysis
  • drug efficacy testing
Immunogenicity testing
  • multi-tiered approach: screening – confirmation – neutralization
  • additional characterization: isotype and subclass differentiation
  • innovative platform: affinity characterization of ADA
Immune monitoring
  • phenotyping of immune cell populations
  • cytokine analysis
  • complement activation
Biomarker analysis
  • quantification of DNA, RNA and protein analytes,
  • mutational analysis
  • analysis of phenotype drug response relationships
Cell-based assays
  • reporter gene assays
  • immune cell activation
  • cytokine release assay
  • organotypic disease modelling

Consultancy

Our expert team provides you with scientific support through every step of product development, making sure you maximize value at each stage:

Integrated data analysis:
Data interpretation and risk assessments from early research stages to market authorization

Scientific advice:
Steer scientifically informed interactions with regulatory agencies and data safety monitoring committees

Regulatory compliance:
Quality assurance support and external audits

Partnerships

Technical risks in drug development can be reduced by close collaborations and data sharing. We share our long standing academic and industry experience to create scientific excellence for your drug development program.

Innovative solutions:
Rapidly overcome obstacles and bottlenecks in drug discovery and drug testing

Contract research:
Develop novel analytical technologies and innovative cell and tissue based tools for drug discovery and development

Research fund acquisition:
Joint effort fund applications with industry and academia at national and international level

Technologies

Innovative – customized – automated – quality assured!

 

Analytical platforms & technologies

Our GLP-compliant bioanalytical facility is equipped with state-of-the-art analytical platforms, to ensure the highest standards of bioanalysis for large molecules. We provide you with rapid, robust and reliable results for your preclinical and clinical study.

Contact us for guidance, which platforms fit best to your needs.

 

ELISA - Enzyme-linked immunosorbent assays

Fully validated platform provides fast, reliable and cost-effective results for pharmacokinetics and immunogenicity

MSD-ECL - Meso Scale Discovery Electrochemiluminescence

Plate-based electrochemical luminescence technology allows high sensitivity and high drug tolerance for immunogenicity and multiplex cytokine analysis

Phadia 250 ImmunoCap

Detection of low abundant IgE antibodies to quantitatively characterize drug induced immune responses

BCS XP Siemens

Fully automated high throughput analyser for clotting, chromogenic, immunologic and agglutination testing

QuantStudio 7 Flex Real-Time PCR System

Reliable gene expression data and genetic biomarker quantification with qPCR assays based on customized DNA and RNA preparation from any biospecimen

BioRad BioPlex 200

Multiplexed immunoassays in low sample volumes using Luminex magnetic beads for the sensitive quantification of a wide range of macromolecular analytes like cytokines

Flow cytometry

Versatile platform for immune monitoring in complex matrices like whole blood and for innovative analysis for complex product characterizations

FPLC - Fast protein liquid chromatography

Reliable, reproducible and automated separation of macromolecules, including proteins, oligonucleotides and plasmids

Octet Biolayer Interferometry

Label-free analysis of biomolecular interactions in real-time

Cell culture

Cell-based assays have emerged as an effective and strong complementation of other technologies in drug discovery. Our BSL2 certified laboratories provide the framework to assess your product´s safety profile, biological activity, biochemical mechanisms and off-target effects. We develop customized cell-based assays to answer your research questions with full consideration of the specific characteristics of your therapeutic goals.

Bioimaging

Live cell imaging and high-resolution confocal microscopy supplement complex cell-based assays. At the technology core facility of the university campus in Krems we use high-end bioimaging technologies including the Leica TCS SP8 system with tandem scanner, acousto-optical beam splitter, filter free spectral detector modul and HyVolution modul for confocal lateral super-resolution up to 140nm. Furthermore, we have access to Leica DMI6000B microscopes for phase contrast, DIC and wide field fluorescence microscopy including deconvolution and Leica application software modules.

Research & Development

Extensive scientific track record

Publications

Based on the comprehensive scientific expertise of key staff members in academia and biotech/pharmaceutical industry we have developed a strong track record in applied research and drug development.

During their scientific and pharmaceutical careers, our team members contributed to the successful development and launch of multiple drugs in our core area of hemophilia and hematology.

Check our published record in developing new innovative approaches for bioanalytical applications.

Product development

Evaluation of factor VIII polysialylation: Identification of a longer-acting experimental therapy in mice and monkeys.  Glantschnig H, Bauer A, Benamara K, Dockal M, Ehrlich V, Gritsch H, Hobarth G, Horling FM, Kopic A, Leidenmuhler P, Reipert BM, Rottensteiner H, Ruthsatz T, Schrenk G, Schuster M, Turecek PL, Weber A, Wolfsegger M, Scheiflinger F, Hollriegl W. J Pharmacol Exp Ther. 2019 Jul 31. pii: jpet.119.260067. doi: 10.1124/jpet.119.260067.

Comparative analysis of marketed factor VIII products: recombinant products are not alike vis-a-vis soluble protein aggregates and subvisibleparticles. Anzengruber J, Lubich C, Prenninger T, Gringeri A, Scheiflinger F, Reipert BM, Malisauskas M. J Thromb Haemost. 2018 Jun;16(6):1176-1181. doi: 10.1111/jth.14125. Epub 2018 May 11.

A Screening Approach for Identifying Gliadin Neutralizing Antibodies on Epithelial Intestinal Caco-2 Cells. Hundsberger H, Koppensteiner A, Hofmann E, Ripper D, Pflüger M, Stadlmann V, Klein CT, Kreiseder B, Katzlinger M, Eger A, Forster F, Missbichler A, Wiesner C. SLAS Discov. 2017 Sep;22(8):1035-1043. doi: 10.1177/2472555217697435. Epub 2017 Mar 9.

Preclinical assessment of a new recombinant ADAMTS-13 drug product (BAX930) for the treatment of thrombotic thrombocytopenic purpura. Kopić A, Benamara K, Piskernik C, Plaimauer B, Horling F, Höbarth G, Ruthsatz T, Dietrich B, Muchitsch EM, Scheiflinger F, Turecek M, Höllriegl W. J Thromb Haemost. 2016 Jul;14(7):1410-9. doi: 10.1111/jth.13341. Epub 2016 Jul 2.

Porcine recombinant factor VIII (Obizur; OBI-1; BAX801): product characteristics and preclinical profile. Lillicrap D, Schiviz A, Apostol C, Wojciechowski P, Horling F, Lai CK, Piskernik C, Hoellriegl W, Lollar P. Haemophilia. 2016 Mar;22(2):308-317. doi: 10.1111/hae.12784. Epub 2015 Aug 17.

Nonacog gamma, a novel recombinant factor IX with low factor IXa content for treatment and prophylaxis of bleeding episodes. Turecek PL, Abbühl B, Tangada SD, Chapman M, Gritsch H, Rottensteiner H, Schrenk G, Mitterer A, Dietrich B, Höllriegl W, Schiviz A, Horling F, Reipert BM, Muchitsch EM, Pavlova BG, Scheiflinger F. Expert Rev Clin Pharmacol. 2015 Mar;8(2):163-77. doi: 10.1586/17512433.2015.1011126. Epub 2015 Feb 8.

Antimicrobial and anti-inflammatory activities of endophytic fungi Talaromyces wortmannii extracts against acne-inducing bacteria. Pretsch A, Nagl M, Schwendinger K, Kreiseder B, Wiederstein M, Pretsch D, Genov M, Hollaus R, Zinssmeister D, Debbab A, Hundsberger H, Eger A, Proksch P, Wiesner C. PLoS One. 2014 Jun 2;9(6):e97929. doi: 10.1371/journal.pone.0097929. eCollection 2014.

Novel Aeruginosin-865 from Nostoc sp. as a potent anti-inflammatory agent. Kapuścik A, Hrouzek P, Kuzma M, Bártová S, Novák P, Jokela J, Pflüger M, Eger A, Hundsberger H, Kopecký J. Chembiochem. 2013 Nov 25;14(17):2329-37. doi: 10.1002/cbic.201300246. Epub 2013 Oct 2.

Preclinical safety and efficacy of a new recombinant FIX drug product for treatment of hemophilia B. Dietrich B, Schiviz A, Hoellriegl W, Horling F, Benamara K, Rottensteiner H, Turecek PL, Schwarz HP, Scheiflinger F, Muchitsch EM. Int J Hematol. 2013 Nov;98(5):525-32. doi: 10.1007/s12185-013-1448-z. Epub 2013 Sep 24.

beta-Catenin and TGFbeta signalling cooperate to maintain a mesenchymal phenotype after FosER-induced epithelial to mesenchymal transition. Eger A, Stockinger A, Park J, Langkopf E, Mikula M, Gotzmann J, Mikulits W, Beug H, Foisner R. Oncogene. 2004 Apr 8;23(15):2672-2680.

New technologies

The detection of biologically relevant low-titer neutralizing antibodies against AAV require sensitive in vitro assays. Kruzik A, Koppensteiner H, Fetahagic D, Hartlieb B, Dorn S, Romeder-Finger S, Coulibaly S, Weber A, Höllriegl W, Horling FM, Scheiflinger F, Reipert BM, de la Rosa M. Hum Gene Ther Methods. 2019 Feb 8. doi: 10.1089/hgtb.2018.263.

Organotypic three-dimensional cancer cell cultures mirror drug responses in vivo: lessons learned from the inhibition of EGFR signaling. Jacobi N, Seeboeck R, Hofmann E, Schweiger H, Smolinska V, Mohr T, Boyer A, Sommergruber W, Lechner P, Pichler-Huebschmann C, Önder K, Hundsberger H, Wiesner C, Eger A. Oncotarget. 2017 Nov 17;8(64):107423-107440. doi: 10.18632/oncotarget.22475. eCollection 2017 Dec 8.

The Mystery of Antibodies Against Polyethylene Glycol (PEG) – What do we Know? Lubich C, Allacher P, de la Rosa M, Bauer A, Prenninger T, Horling FM, Siekmann J, Oldenburg J, Scheiflinger F, Reipert BM. Pharm Res. 2016 Sep;33(9):2239-49. doi: 10.1007/s11095-016-1961-x. Epub 2016 Jun 7.

A false sense of security? Can tiered approach be trusted to accurately classify immunogenicity samples? Jaki T, Allacher P, Horling F. J Pharm Biomed Anal. 2016 Sep 5;128:166-173. doi: 10.1016/j.jpba.2016.05.031. Epub 2016 May 27.

The combinatorial approach of laser-captured microdissection and reverse transcription quantitative polymerase chain reaction accurately determines HER2 status in breast cancer. Hofmann E, Seeboeck R, Jacobi N, Obrist P, Huter S, Klein C, Oender K, Wiesner C, Hundsberger H, Eger A. Biomark Res. 2016 Apr 7;4:8. doi: 10.1186/s40364-016-0062-7. eCollection 2016.

A Flow-Cytometry-Based Approach to Facilitate Quantification, Size Estimation and Characterization of Sub-visible Particles in Protein Solutions. Lubich C, Malisauskas M, Prenninger T, Wurz T, Matthiessen P, Turecek PL, Scheiflinger F, Reipert BM. Pharm Res. 2015 Sep;32(9):2863-76. doi: 10.1007/s11095-015-1669-3. Epub 2015 Mar 19.

Affinity of FVIII-specific antibodies reveals major differences between neutralizing and nonneutralizing antibodies in humans. Hofbauer CJ, Whelan SF, Hirschler M, Allacher P, Horling FM, Lawo JP, Oldenburg J, Tiede A, Male C, Windyga J, Greinacher A, Knöbl PN, Schrenk G, Koehn J, Scheiflinger F, Reipert BM. Blood. 2015 Feb 12;125(7):1180-8. doi: 10.1182/blood-2014-09-598268. Epub 2014 Dec 16.

A comparison of methods for classifying samples as truly specific with confirmatory immunoassays. Jaki T, Lawo JP, Wolfsegger MJ, Allacher P, Horling F. J Pharm Biomed Anal. 2014 Jan;88:27-35. doi: 10.1016/j.jpba.2013.08.013. Epub 2013 Aug 21.

Real-time monitoring of relative peptide-protein interaction strengths in the yeast two-hybrid system. Rid R, Herzog J, Maier RH, Hundsberger H, Eger A, Hintner H, Bauer JW, Onder K. Assay Drug Dev Technol. 2013 May;11(4):269-75. doi: 10.1089/adt.2012.496.

Distinct characteristics of antibody responses against factor VIII in healthy individuals and in different cohorts of hemophilia A patients. Whelan SF, Hofbauer CJ, Horling FM, Allacher P, Wolfsegger MJ, Oldenburg J, Male C, Windyga J, Tiede A, Schwarz HP, Scheiflinger F, Reipert BM. Blood. 2013 Feb 7;121(6):1039-48. doi: 10.1182/blood-2012-07-444877. Epub 2012 Dec 12.

A combined impedance and AlphaLISA-based approach to identify anti-inflammatory and barrier-protective compounds in human endothelium. Pflüger M, Kapuscik A, Lucas R, Koppensteiner A, Katzlinger M, Jokela J, Eger A, Jacobi N, Wiesner C, Hofmann E, Onder K, Kopecky J, Schütt W, Hundsberger H. J Biomol Screen. 2013 Jan;18(1):67-74. doi: 10.1177/1087057112458316. Epub 2012 Aug 30.

A formal comparison of different methods for establishing cut points to distinguish positive and negative samples in immunoassays. Jaki T, Lawo JP, Wolfsegger MJ, Singer J, Allacher P, Horling F. J Pharm Biomed Anal. 2011 Jul 15;55(5):1148-56. doi: 10.1016/j.jpba.2011.04.006. Epub 2011 Apr 15.

Basic research

Prevalence of Anti-Adeno-Associated Virus Immune Responses in International Cohorts of Healthy Donors. Kruzik A, Fetahagic D, Hartlieb B, Dorn S, Koppensteiner H, Horling FM, Scheiflinger F, Reipert BM, de la Rosa M. Mol Ther Methods Clin Dev. 2019 Jun 7;14:126-133. doi: 10.1016/j.omtm.2019.05.014. eCollection 2019 Sep 13

Factor IX inhibitors: Clinical and laboratory profiles of two patients with severe haemophilia. B. Saini S, Croteau SE, Horling FM, Dunn AL. Haemophilia. 2019 Mar;25(2):e126-e129. doi: 10.1111/hae.13696. Epub 2019 Feb 28. No abstract available

ErbB Family Signalling: A Paradigm for Oncogene Addiction and Personalized Oncology. Jacobi N, Seeboeck R, Hofmann E, Eger A. Cancers (Basel). 2017 Apr; 9(4): 33.
Published online 2017 Apr 12. doi: 10.3390/cancers9040033

Fra-1/AP-1 induces EMT in mammary epithelial cells by modulating Zeb1/2 and TGFβ expression. Bakiri L, Macho-Maschler S, Custic I, Niemiec J, Guío-Carrión A, Hasenfuss SC, Eger A, Müller M, Beug H, Wagner EF. Cell Death Differ. 2015 Feb;22(2):336-50. doi: 10.1038/cdd.2014.157. Epub 2014 Oct 10.

Interaction of tumor cells with the immune system: implications for dendritic cell therapy and cancer progression. Imhof M, Karas I, Gomez I, Eger A, Imhof M. Drug Discov Today. 2013 Jan;18(1-2):35-42. doi: 10.1016/j.drudis.2012.07.010. Epub 2012 Jul 27.

CD4+ T-cell epitopes associated with antibody responses after intravenously and subcutaneously applied human FVIII in humanized hemophilic E17 HLA-DRB1*1501 mice. Steinitz KN, van Helden PM, Binder B, Wraith DC, Unterthurner S, Hermann C, Schuster M, Ahmad RU, Weiller M, Lubich C, de la Rosa M, Schwarz HP, Reipert BM. Blood. 2012 Apr 26;119(17):4073-82.

T cell-independent restimulation of FVIII-specific murine memory B cells is facilitated by dendritic cells together with toll-like receptor 7 agonist. Pordes AG, Baumgartner CK, Allacher P, Ahmad RU, Weiller M, Schiviz AN, Schwarz HP, Reipert BM. Blood. 2011 Sep 15;118(11):3154-62.

Stimulation and inhibition of FVIII-specific memory B-cell responses by CpG-B (ODN 1826), a ligand for Toll-like receptor 9. Allacher P, Baumgartner CK, Pordes AG, Ahmad RU, Schwarz HP, Reipert BM. Blood. 2011 Jan 6;117(1):259-67.

Immunology of Inhibitor Development Reipert BM, Hofbauer CJ, Steinitz KN, Schwarz HP, Horling FM. Book chapter in: Current and future issues in Hemophilia Care ed. by Rodriguez- Merchan EM and Valentino LA 2011

Modulation of factor VIII-specific memory B cells. Reipert BM, Allacher P, Hausl C, Pordes AG, Ahmad RU, Lang I, Ilas J, Windyga J, Klukowska A, Muchitsch EM, Schwarz HP. Haemophilia. 2010 May;16(102):25-34.

The transcriptional repressor ZEB1 promotes metastasis and loss of cell polarity in cancer. Spaderna S, Schmalhofer O, Wahlbuhl M, Dimmler A, Bauer K, Sultan A, Hlubek F, Jung A, Strand D, Eger A, Kirchner T, Behrens J, Brabletz T. Cancer Res. 2008 Jan 15;68(2):537-44. doi: 10.1158/0008-5472.CAN-07-5682.

The transcription factor ZEB1 (deltaEF1) promotes tumour cell dedifferentiation by repressing master regulators of epithelial polarity. Aigner K, Dampier B, Descovich L, Mikula M, Sultan A, Schreiber M, Mikulits W, Brabletz T, Strand D, Obrist P, Sommergruber W, Schweifer N, Wernitznig A, Beug H, Foisner R, Eger A. Oncogene. 2007 Oct 25;26(49):6979-88. Epub 2007 May 7.

The transcription factor ZEB1 (δEF1) represses Plakophilin 3 during human cancer progression. Aigner K, Descovich L, Mikula M, Sultan A, Dampier B, Bonné S, van Roy F, Mikulits W, Schreiber M, Brabletz T, Sommergruber W, Schweifer N, Wernitznig A, Beug H, Foisner R,Eger A. FEBS Lett. 2007 Apr 17; 581(8): 1617–1624.
Published online 2007 Mar 21. doi: 10.1016/j.febslet.2007.03.026

DeltaEF1 is a transcriptional repressor of E-cadherin and regulates epithelial plasticity in breast cancer cells. Eger A, Aigner K, Sonderegger S, Dampier B, Oehler S, Schreiber M, Berx G, Cano A, Beug H, Foisner R. Oncogene. 2005 Mar 31;24(14):2375-85.

E-cadherin regulates cell growth by modulating proliferation-dependent beta-catenin transcriptional activity. Stockinger A, Eger A, Wolf J, Beug H, Foisner R. J Cell Biol. 2001 Sep 17;154(6):1185-96.

Epithelial mesenchymal transition by c-Fos estrogen receptor activation involves nuclear translocation of beta-catenin and upregulation of beta-catenin/lymphoid enhancer binding factor-1 transcriptional activity. Eger A, Stockinger A, Schaffhauser B, Beug H, Foisner R. J Cell Biol. 2000 Jan 10;148(1):173-88.

Career

As an expanding company rooted in medical research and active in an international market, we recognize the crucial role our staff plays in the realisation of our ambitious goals. Our employees are working on innovative drug development programs of international pharmaceutical companies. To meet the highest standards, we continuously invest into training our staff to master modern technological advances. Our scientific and technical staff have the opportunity to work on tasks and projects that constantly offer new challenges.

At home in an attractive region, we are your modern partner to realise professional ambitions in an international environment. This is reflected also in our attractive remuneration and benefits programs.

We always welcome applications from highly qualified scientific and technical personnel with ambition and dedication. If you share our commitment to making a difference for our customers with high-quality bioanalytical services, please take the initiative and get in touch.

Apply with your CV and motivation letter clearly stating your anticipated position in our company!

Contact us

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Krems Bioanalytics

part of IMC University of Applied Sciences Krems
Research Institute for Applied Bioanalytics and Drug Development

Office & Laboratories: Technology & Research Center

Magnesitstr. 1
A-3500 Krems
Austria

+43-(0)2732-802-248

office@krems-bioanalytics.com

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