Biognosys Announces GLP Certification of Its Proteomics Facility by the Swiss Health Authorities
Biognosys, a leader in next-generation proteomics solutions for drug discovery and development, announced today that it has obtained Good Laboratory Practice (GLP) certification from Swiss health authorities for preclinical studies. With this certification, Biognosys has become the first global proteomics service provider to be GLP certified, alongside being fully compliant with Good Clinical Practice (GCP).
This regulatory milestone showcases Biognosys’ rigorous adherence to international research standards for preclinical and clinical studies. This achievement resulted from a partnership with Roche and the setup of an extensive quality management system for the purpose of using discovery proteomics in clinical trials, an effort that spanned several years.
Nadine Frankenberg, PhD, Head of Quality Assurance at Biognosys, commented: “The GLP certification by the Swiss health authorities is a strong recognition of our highly qualified personnel and the rigorous quality standards across all aspects of our services.”
Karel Novy, PhD, Chief Operating Officer of Biognosys, stated: “Delivering the best possible data in terms of depth and quality has always been at the core of Biognosys’ proteomics approach. Our recent GLP certification formalizes this long-standing effort and provides our customers with the opportunity to expand the use of proteomics across the full spectrum of preclinical and clinical studies.”
The GLP certification is based on the Swiss Ordinance on Good Laboratory Practice and the Organisation for Economic Co-operation and Development (OECD) principles on GLP. The certificate has been granted following an inspection of the Biognosys test facilities by the Swiss GLP Monitoring Authorities.
For clinical studies requiring GCP compliance, the company conforms to the ICH guideline for good clinical practice and the EMA reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples.
Biognosys operates one of the largest high-end mass spectrometry laboratories in the world for large-scale proteomics contract research, offering industry-leading throughput while maintaining unprecedented precision and depth. Thanks to its experienced lab personnel, high-quality sample processing and high-throughput instruments park, Biognosys delivers projects with a fast turnaround time as required for clinical trials and routinely performs large-scale studies with more than 1,000 samples for global pharma and biotech customers, academia, or consortia.
Biognosys’ discovery proteomics solutions deploy proprietary, patented Hyper Reaction Monitoring (HRM™) technology and optimized liquid chromatography - mass spectrometry (LC-MS) workflows to search the complete proteome and quantify thousands of the most relevant proteins and peptide-level datapoints. They can be applied to tissues or biofluids across all biological species to provide a deep understanding of key disease pathways. In addition, the clinical transferability of this technology allows quick transition from early-stage discovery to specific, targeted panels that can be applied in a regulated setting.
About Biognosys
Biognosys is a leader in next-generation proteomics, dedicated to transforming life science by inventing and developing cutting-edge proteomics technology and solutions and making them widely available for pharmaceutical and biotechnology researchers and proteomics experts. The Company offers a versatile portfolio of proprietary proteomics services, software, and kits that provide a multi-dimensional view of protein expression, function, and structure in all biological species and sample types. Biognosys’ unique, patented technologies utilize high-resolution mass spectrometry to quantify thousands of proteins across thousands of samples with industry-leading precision, depth, and throughput. Through advanced data analytics, Biognosys translates data into actionable insights for R&D and clinical research. More information at biognosys.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220113005041/en/
Contact information
Yves Serroen
Head of Marketing
Phone +41 (0) 79 571 09 21
yves.serroen@biognosys.com
About Business Wire
Business Wire(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
H.I.G. Capital Announces the Sale of DGS S.p.A.11.6.2024 12:00:00 CEST | Press release
H.I.G. Capital (“H.I.G.”), a leading global alternative investment firm with $62 billion of capital under management, is pleased to announce that an affiliate has signed a definitive agreement to sell its portfolio company, DGS S.p.A. (“DGS” or the “Group”), a leading firm in the Italian Information Technology market, to DGS Co-Founders and management team in partnership with ICG, a global alternative asset manager. Since its inception in 1997, DGShas supported blue-chip customers in the design, integration, and maintenance of complex IT systems, with a specialization in digital transformation and cybersecurity services. The Group currently has over 1,900 employees, revenues of approximately €300 million, and maintains a group of highly loyal clientele. During H.I.G.’s ownership, DGS has tripled in size and consolidated its position as a leading Italian firm in cybersecurity services and digital transformation. DGS offers its clients sophisticated and proprietary digital transformation
Evertas Names Nick Selby Head of European Underwriting11.6.2024 12:00:00 CEST | Press release
Evertas, the world’s first crypto insurance company, has named Nick Selby as its new Head of European Underwriting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611141887/en/ Nick Selby, Executive Vice President and Head of European Underwriting at Evertas (Photo: Business Wire) Selby, an accomplished information and physical security professional, brings two decades of expertise in public and private sector information security, physical security, and complex incident handling, as well as seven years of experience leading teams securing billions of dollars in cryptoassets. Previously, his roles included VP of the Software Assurance Practice at Trail of Bits, Chief Security Officer at Paxos Trust Company, and Director of Cyber Intelligence and Investigations at the NYPD Intelligence Bureau. “Nick is an extremely valuable addition to our European team,” said Evertas CEO and Co-Founder J. Gdanski. “His public and private
Owlet utvider globalt fotavtrykk med lanseringen av medisinsk-sertifisert Dream Sock™ i Storbritannia og over hele Europa11.6.2024 11:00:00 CEST | Pressemelding
Owlet, Inc. («Owlet» or the «Company») (NYSE:OWLT), pioneren innen smart spedbarnsovervåking, kunngjør i dag den britiske og europeiske lanseringen av Dream Sock. Dette er en smart babymonitor med levende helseavlesninger og varsler for friske spedbarn mellom 0-18 måneder og 2,5-13,6 kg. Dette innovative medisinske utstyret gir foreldre helse og viktig informasjon i sanntid, noe som gir uovertruffen trygghet. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20240611820341/no/ (Photo: Business Wire) «Vi er svært stolte over å lansere Dream Sock til omsorgspersoner over hele Storbritannia og Europa og gi millioner av foreldre mer trygghet mens babyen sover,» sa Kurt Workman, Owlets administrerende direktør og medgründer. «Dream Sock er nå et globalt produkt som er anerkjent som medisinsk nøyaktig og trygt, etter å ha gjennomgått regulatoriske autorisasjoner og sertifiseringer innenfor flere geografier. I dag er misjonen vår
V-Nova Surpasses 1000 Patent Milestone in Media Technology Innovation11.6.2024 10:00:00 CEST | Press release
V-Nova, a leading provider of data compression solutions, video compression technology, XR technology, AI acceleration and parallel processing for a multitude of industries including media and entertainment, today announced its milestone achievement of 1000 active technology patents. This accomplishment underscores V-Nova’s dedication to research and development and its commitment to protecting its intellectual property globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611724561/en/ V-Nova’s patent portfolio spans more than 50 different jurisdictions. Including over 400 patents in Europe, over 200 in the Americas, over 100 in the United States specifically, and over 200 in Asia. V-Nova forged new directions in data processing to enhance digital experiences, maximize efficiency, reduce costs, and increase sustainability. The company leads the way with key international data compression standards for the video indust
Alipay+ Reveals Top Scorer Trophy Design for UEFA EURO 2024™11.6.2024 09:24:00 CEST | Press release
Alipay+, a suite of cross-border mobile payment and digitalization technology solutions operated by Ant International and an Official Partner of UEFA EURO 2024™, today revealed the trophy that will be awarded to the most prolific marksman at the UEFA EURO 2024™ finale on July 14 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610328619/en/ The UEFA Top Scorer Trophy presented by Alipay+ is unveiled for UEFA EURO 2024™ (Photo: Business Wire) Sculpted in the shape of the Chinese character “支” (pronounced zhi, and meaning payment as well as support), the trophy reflects Alipay+’s dedication to supporting consumers to enjoy seamless payment and a broad choice of deals using their preferred payment methods while traveling abroad. The character also resembles the fleeting moment of a barefooted striker poised to shoot, evoking the original beauty and power of football – a game that united people across the wo