BIOGNOSYS
13.1.2022 14:02:06 CET | Business Wire | Press release
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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20220113005041/en/
Link:
About Business Wire
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
2PointZero Group Signals Global Scale With Revenue Surge to AED 21.9 Billion and Net Profit of AED 7.7 Billion in H1 202631.7.2026 13:42:00 CEST | Press release
Group revenue growth supported by stable gross profit margin of 29%, and adjusted EBITDA of AED 5.0 billionGlobal expansion milestones include the completed sale of TAQA stake, and the acquisition of Traverse Midstream Partners in North America, Baobab Group in Africa, and 60.8% of ISEM in ItalyTIME ranks the Group 36th on the World’s Growth Leaders list for 2026, highlighting market stability, operational scale and disciplined approach to capital 2PointZero Group (ADX: 2POINTZERO), a leading Abu Dhabi-based investment holding firm, announced its financial results for the first half of 2026, reporting revenue of AED 21.9 billion and delivering a Group Net Profit of AED 7.7 billion. This robust performance is reflected in the Group’s adjusted EBITDA, which reached AED 5.0 billion after excluding fair value changes and one-offs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260731538982/en/ Samia Bouazza, CEO of 2PointZero (P
Datroway® Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy31.7.2026 08:30:00 CEST | Press release
Approval based on TROPION-Breast02 phase 3 trial results where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival Datroway now approved for two breast cancer indications in the EU Datroway® (datopotamab deruxtecan) has been approved in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The approval by the European Commission follows the positive opinionof the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on result
Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate31.7.2026 08:30:00 CEST | Press release
Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda’s reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. The BLA and MAA acceptances represent significant milestones in Polpharma Biologics' development program and underscore the company's commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines. "FDA and EMA acceptances for review of our IV vedolizumab biosimilar candidate mark a major achievement for Polpharma Biologics and validate our deep scientific expertise in biosimilar development and manufacturing," said
SES: Disclosure of Share Buyback Transactions31.7.2026 07:30:00 CEST | Press release
In the time period from June 2, 2026 until and including June 23, 2026, a number of 213,167 shares were bought back within the framework of the share buyback of SES to meet obligations under SES’s Equity Based Compensation Plan (EBCP). Shares were bought back as follows: Day of purchase Aggregated volume in shares Daily weighted average acquisition price of shares (EUR) Market June 2, 2026 27,097 8.8727 DXE June 2, 2026 72,903 8.8556 ENX June 5, 2026 16,624 8.3723 DXE June 5, 2026 31,510 8.4266 ENX June 15, 2026 26,451 7.8423 XPAR June 17, 2026 26,812 7.3910 XPAR June 23, 2026 11,770 7.2200 XPAR The transactions in a detailed form are published on SES’s website: https://www.ses.com/investors/shareholder-information/share-buy-backs. Follow us on: Twitter | Facebook | YouTube | LinkedIn | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we believe that space has the power to make a difference. That’s why we design space solutions that help governments protect, busin
Half-Year Report on SES’s Liquidity Contract31.7.2026 07:30:00 CEST | Press release
Pursuant to the liquidity contract entered into by SES with BNP Paribas as of 7 April 2026, please see the below update on the progress of the liquidity services. When the liquidity services were implemented as of 7 April 2026, the following assets were in the liquidity account: € 2,500,000 As of 30 June 2026, the following assets appeared on the liquidity account: 228,186 shares; € 816,880. Over the period from 7 April 2026 to 30 June 2026, the following transactions were executed: 1,082 buy transactions; 1,308 sales transactions. Over this same period, the volumes traded represented: 1,093,335 shares and € 8,485,986 on the buy side; 873,399 shares and € 6,860,843 on the sell side. Follow us on: LinkedIn | Facebook | YouTube | X | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we believe that space has the power to make a difference. That’s why we design space solutions that help governments protect, businesses grow, and people stay connected—no matter where th
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom