Hyglos GmbH

Bernried, Germany

Hyglos GmbH

Bernried, Germany

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News Article | November 22, 2016
Site: www.newsmaker.com.au

According to Stratistics MRC, the Global Pyrogen Testing market is accounted for $552.1 million in 2015 and is expected to reach $1,425.1 million by 2022 growing at a CAGR of 14.5% from 2015 to 2022. Rapidly growing healthcare, pharmaceutical and biotechnology industries are primarily favouring the pyrogen testing market. Furthermore, favourable government policies, discovery of new innovative drugs and high incidence of chronic diseases are the factors enhancing market growth. However, strict regulatory norms and high degree consolidation in pharmaceutical industry are limiting the growth of pyrogen testing market. Pharmaceutical outsourcing and rapidly developing healthcare infrastructure in emerging countries offer tremendous growth opportunities for key players in the global market. Access the complete report at: http://www.strategymrc.com/report/pyrogen-testing-market Kits & reagents segment is likely to acquire the highest market share during the forecast period and is also expected to grow at a higher CAGR. The growth of this segment is attributed to rising adoption and repeat purchase of these products. By test type, In Vitro Tests segment is expected to witness high growth rate during the forecast period. North America is anticipated to be the largest market for Pyrogen Testing and Asia Pacific is projected to grow at a faster pace. The growth of APAC is attributed to the increasing population, developing healthcare infrastructure, rising disposable income, availability of manpower at cheaper rate and outsourcing by key players in developed nations. Some of the key players in the global market include Merck & Co., Inc., Waters Corporation, Ellab A/S, WUXI Pharmatech (Cayman) Inc., Thermo Fisher Scientific, Inc., Genscript, Charles River Laboratories International, Inc., Sigma-Aldrich Corporation, Hyglos Gmbh, Associates of Cape Cod, Inc., Lonza Group and Wako Chemicals USA, Inc. Request for a sample at: http://www.strategymrc.com/report/pyrogen-testing-market Test Types Covered: • In Vitro Tests             • Limulus Amoebocyte Lysate (LAL) Tests               o Gel Clot Tests o Turbidimetric Tests   o Chromogenic Tests   • Rabbit Test Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK  o Spain   o Rest of Europe     • Asia Pacific o Japan        o China        o India        o Australia        o New Zealand       o Rest of Asia Pacific     •  Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements


Reich J.,University of Regensburg | Lang P.,Hoffmann-La Roche | Grallert H.,Hyglos GmbH | Motschmann H.,University of Regensburg
Biologicals | Year: 2016

Over the last few decades . Limulus Amebocyte Lysate (LAL) has been the most sensitive method for the detection of endotoxins (Lipopolysaccharides) and is well accepted in a broad field of applications. Recently, Low Endotoxin Recovery (LER) in biopharmaceutical drug products has been noticed, whereby the detection of potential endotoxin contaminations is not ensured. Notably, most of these drug products contain surfactants, which can have crucial effects on the detectability of endotoxin. In order to analyze the driving forces of LER, endotoxin detection in samples containing nonionic surfactants in various buffer systems was investigated. The results show that the process of LER is kinetically controlled and temperature-dependent. Furthermore, only the simultaneous presence of nonionic surfactants and components capable of forming metal complexes resulted in LER. In addition, capacity experiments show that even hazardous amounts of endotoxin can remain undetectable within such formulation compositions. In conclusion, the LER phenomenon is caused by endotoxin masking and not by test interference. In this process, the supramolecular structure of endotoxin is altered and exhibits only a limited susceptibility in binding to the Factor C of . Limulus-based detection systems. We propose a two-step mechanism of endotoxin masking by complex forming agents and nonionic surfactants. © 2016 The Author(s).


PubMed | Hoffmann-La Roche, Hyglos GmbH and University of Regensburg
Type: Journal Article | Journal: Biologicals : journal of the International Association of Biological Standardization | Year: 2016

Over the last few decades Limulus Amebocyte Lysate (LAL) has been the most sensitive method for the detection of endotoxins (Lipopolysaccharides) and is well accepted in a broad field of applications. Recently, Low Endotoxin Recovery (LER) in biopharmaceutical drug products has been noticed, whereby the detection of potential endotoxin contaminations is not ensured. Notably, most of these drug products contain surfactants, which can have crucial effects on the detectability of endotoxin. In order to analyze the driving forces of LER, endotoxin detection in samples containing nonionic surfactants in various buffer systems was investigated. The results show that the process of LER is kinetically controlled and temperature-dependent. Furthermore, only the simultaneous presence of nonionic surfactants and components capable of forming metal complexes resulted in LER. In addition, capacity experiments show that even hazardous amounts of endotoxin can remain undetectable within such formulation compositions. In conclusion, the LER phenomenon is caused by endotoxin masking and not by test interference. In this process, the supramolecular structure of endotoxin is altered and exhibits only a limited susceptibility in binding to the Factor C of Limulus-based detection systems. We propose a two-step mechanism of endotoxin masking by complex forming agents and nonionic surfactants.


Idelevich E.A.,University of Munster | Von Eiff C.,University of Munster | Von Eiff C.,Pfizer | Friedrich A.W.,University of Munster | And 7 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2011

Antistaphylococcal activity of the novel chimeric endolysin PRF-119 was evaluated with the microdilution method. The MIC50 and MIC90 of 398 methicillin-susceptible Staphylococcus aureus isolates were 0.098 μg/ml and 0.391 μg/ml, respectively (range, 0.024 to 0.780 μg/ml). Both the MIC50 and MIC90 values of 776 methicillin-resistant S. aureus isolates were 0.391 μg/ml (range, 0.024 to 1.563 μg/ml). All 192 clinical isolates of coagulase-negative staphylococci exhibited MIC values of >50 μg/ml. In conclusion, PRF-119 exhibited very good activity specifically against S. aureus. Copyright © 2011, American Society for Microbiology. All Rights Reserved.


Idelevich E.A.,University of Munster | Walther T.,Hyglos GmbH | Molinaro S.,Hyglos GmbH | Molinaro S.,MicroCoat Biotechnologie GmbH | And 10 more authors.
Journal of Clinical Microbiology | Year: 2014

Rapid diagnosis is essential for the management of Staphylococcus aureus infections. A host recognition protein from S. aureus bacteriophage phiSLT was recombinantly produced and used to coat streptavidin latex beads to develop a latex agglutination test (LAT). The diagnostic accuracy of this bacteriophage-based test was compared with that of a conventional LAT, Pastorex Staph-Plus, by investigating a clinical collection of 86 S. aureus isolates and 128 coagulase-negative staphylococci (CoNS) from deep tissue infections. All of the clinical S. aureus isolates were correctly identified by the bacteriophage-based test. While most of the CoNS were correctly identified as non-S. aureus isolates, 7.9% of the CoNS caused agglutination. Thus, the sensitivity of the bacteriophage-based LAT for identification of S. aureus among clinical isolates was 100%, its specificity was 92.1%, its positive predictive value (PPV) was 89.6%, and its negative predictive value (NPV) was 100%. The sensitivity, specificity, PPV, and NPV of the Pastorex LAT for the identification of S. aureus were 100%, 99.2%, 98.9%, and 100%, respectively. Among the additionally tested 35 S. aureus and 91 non-S. aureus staphylococcal reference and type strains, 1 isolate was false negative by each system; 13 and 8 isolates were false positive by the bacteriophage-based and Pastorex LATs, respectively. The ability of the phiSLT protein to detect S. aureus was dependent on the presence of wall teichoic acid (WTA) and corresponded to the production of ribitol phosphate WTA, which is found in most S. aureus clones but only a small minority of CoNS. Bacteriophage-based LAT identification is a promising strategy for rapid pathogen identification. Finding more specific bacteriophage proteins would increase the specificity of this novel diagnostic approach. Copyright © 2014, American Society for Microbiology. All Rights Reserved.


Idelevich E.A.,University of Munster | Schaumburg F.,University of Munster | Knaack D.,University of Munster | Scherzinger A.S.,HyglosGmbH | And 5 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2016

HY-133 is a recombinant bacteriophage endolysin with bactericidal activity against Staphylococcus aureus. Here, HY-133 showed in vitro activity against major African methicillin-susceptible and methicillin-resistant S. aureus lineages and ceftaroline/ceftobiprole-and borderline oxacillin-resistant isolates. HY-133 was also active against Staphylococcus schweitzeri, a recently described species of the S. aureus complex. The activity of HY-133 on the tested isolates (MIC50, 0.25 μg/ml; MIC90, 0.5 μg/ml; range, 0.125 to 0.5 μg/ml) was independent of the species and strain background or antibiotic resistance. Copyright © 2016, American Society for Microbiology. All Rights Reserved.


PubMed | University of Tübingen, Max Von Pettenkofer Institute, Hyglos GmbH and University of Munster
Type: Evaluation Studies | Journal: Journal of clinical microbiology | Year: 2014

Rapid diagnosis is essential for the management of Staphylococcus aureus infections. A host recognition protein from S. aureus bacteriophage phiSLT was recombinantly produced and used to coat streptavidin latex beads to develop a latex agglutination test (LAT). The diagnostic accuracy of this bacteriophage-based test was compared with that of a conventional LAT, Pastorex Staph-Plus, by investigating a clinical collection of 86 S. aureus isolates and 128 coagulase-negative staphylococci (CoNS) from deep tissue infections. All of the clinical S. aureus isolates were correctly identified by the bacteriophage-based test. While most of the CoNS were correctly identified as non-S. aureus isolates, 7.9% of the CoNS caused agglutination. Thus, the sensitivity of the bacteriophage-based LAT for identification of S. aureus among clinical isolates was 100%, its specificity was 92.1%, its positive predictive value (PPV) was 89.6%, and its negative predictive value (NPV) was 100%. The sensitivity, specificity, PPV, and NPV of the Pastorex LAT for the identification of S. aureus were 100%, 99.2%, 98.9%, and 100%, respectively. Among the additionally tested 35 S. aureus and 91 non-S. aureus staphylococcal reference and type strains, 1 isolate was false negative by each system; 13 and 8 isolates were false positive by the bacteriophage-based and Pastorex LATs, respectively. The ability of the phiSLT protein to detect S. aureus was dependent on the presence of wall teichoic acid (WTA) and corresponded to the production of ribitol phosphate WTA, which is found in most S. aureus clones but only a small minority of CoNS. Bacteriophage-based LAT identification is a promising strategy for rapid pathogen identification. Finding more specific bacteriophage proteins would increase the specificity of this novel diagnostic approach.


PubMed | University of Tübingen, Hyglos GmbH and University of Munster
Type: Journal Article | Journal: Antimicrobial agents and chemotherapy | Year: 2016

HY-133 is a recombinant bacteriophage endolysin with bactericidal activity againstStaphylococcus aureus Here, HY-133 showedin vitroactivity against major African methicillin-susceptible and methicillin-resistantS. aureuslineages and ceftaroline/ceftobiprole- and borderline oxacillin-resistant isolates. HY-133 was also active againstStaphylococcus schweitzeri, a recently described species of theS. aureuscomplex. The activity of HY-133 on the tested isolates (MIC50, 0.25 g/ml; MIC90, 0.5 g/ml; range, 0.125 to 0.5 g/ml) was independent of the species and strain background or antibiotic resistance.


Grallert H.,Hyglos GmbH | Leopoldseder S.,Hyglos GmbH | Schutt M.,Hyglos GmbH | Kurze P.,Hyglos GmbH | Buchberger B.,Hyglos GmbH
BioSpektrum | Year: 2011

The new ELISA-based method for the sensitive detection of endotoxin relies on a lipopolysaccharide selective bacteriophage-protein precoated on a microplate and a factor C detection reagent. © 2011 Springer-Verlag Literatur.

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