XBiotech Announces Successful Completion of GMP Audit
First Audit in Company’s New Manufacturing Facility Shows Compliance with GMP Guidelines
AUSTIN, Texas, Dec. 03, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) today announced a successful GMP (Good Manufacturing Practices) audit by Eurofins Amatsigroup. The audit was conducted in connection with XBiotech’s distribution in Europe of its US-manufactured biological drug product. XBiotech manufactures bermekimab at its campus facility in Austin, Texas and regularly ships the drug to clinics in various countries in the European Union and the United Kingdom. Drugs manufactured outside of Europe may only be distributed in Europe through a qualified organization that can assure quality of drug product and manufacturing practices. The Company recently retired its old operations, which included a GMP manufacturing facility, consolidating its programs in a state-of-the-art manufacturing and R&D center on its campus in Austin. This is the first audit of the new facility.
Norma Gonzalez, XBiotech’s Vice President of Quality, commented, “We are revolutionizing the manufacturing of biological drugs in many ways, including in terms of robustness and ease of GMP compliance. We were pleased to be able to once again demonstrate this in the audit process.”
XBiotech recently consolidated operations at its new headquarter facility in Austin, Texas. Operations are now exclusively housed in one complex that includes a custom-built state-of-the-art manufacturing operation, R&D laboratories and administrative space. XBiotech’s facilities are located on a 48 acre estate located only minutes from Austin’s city center. XBiotech developed manufacturing technology using bioreactors designed and built by the Company, employing its technology to dramatically reduced capital costs, plant and equipment operating complexity, and improve production flexibility compared to existing manufacturing commonly used to produce marketed biologics. XBiotech currently produces all of its clinical drug material and plans to manufacture commercial drug product from its Austin headquarters.
About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Photos accompanying this announcement are available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/0558d76a-c4f4-40d7-8c41-808480a0a320 http://www.globenewswire.com/NewsRoom/AttachmentNg/593d4948-7cd5-452e-8cc3-fa0745641503 http://www.globenewswire.com/NewsRoom/AttachmentNg/033b92f0-7956-49d8-bf22-b6984b45211a
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
SoftServe Documentary Receives “The Best Corporate Media of Ukraine 2018” Award17.12.2018 13:00 | Pressemelding
25th anniversary documentary takes prize in “The Best Corporate Movie” category AUSTIN, Texas, Dec. 17, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, announces the Ukrainian Association of Corporate Media, a public organization uniting professionals in the field of marketing, PR, journalism, and advertising, recognized SoftServe in its annual competition – “The Best Corporate Media of Ukraine 2018.” SoftServe’s 25th anniversary documentary took second place in the “The Best Corporate Movie Category.” The documentary honors the company’s 25th anniversary with an inside look at how SoftServe evolved over the past quarter century to become a leading digital authority. In the documentary, SoftServe’s founders and leadership share their inspiring stories and highlight the company’s achievements over the years. “It is a great honor to receive this recognition from the Ukrainian Association of Corporate Media for our 25th anniversary documentary,” sai
Bombardier to supply a further 20 FLEXITY trams to Karlsruhe17.12.2018 10:00 | Pressemelding
Albtal-Verkehrs-Gesellschaft expands its fleet to 62 trams The dual-system vehicles operate on both the tram network and regional railway network BERLIN, Dec. 17, 2018 (GLOBE NEWSWIRE) -- Global mobility solution provider Bombardier Transportation received a call-off order from Albtal-Verkehrs-Gesellschaft mbH (AVG), the transport company of the Alb valley region in southwest Germany, for the delivery of 20 further dual-system BOMBARDIER FLEXITY trams. This third order is based on a framework agreement for a total of 75 vehicles from 2009. The order is valued at approximately 87 million euro ($98 million US). The vehicles will be delivered between May 2020 and March 2021. "Striving to provide attractive local transport services, we have decided to order 20 additional dual-system vehicles from Bombardier Transportation. This will allow us to purposefully enlarge our vehicle fleet offering high-quality standards to our passengers," said Dr. Alexander Pischon, CEO of Albtal-Verkehrs-Gesel
DalCor Announces Completion of Patient Enrollment in dal-GenE, the First Phase 3 Precision Medicine Cardiovascular Outcomes Trial in Coronary Heart Disease17.12.2018 09:00 | Pressemelding
LONDON and MONTREAL, Dec. 17, 2018 (GLOBE NEWSWIRE) -- DalCor today announced the completion of patient enrollment in the dal-GenE study, the first Phase 3 precision medicine cardiovascular outcomes trial in coronary heart disease. The dal-GenE study is evaluating the efficacy of the CETP inhibitor dalcetrapib to reduce clinical cardiovascular events in patients with the AA ADCY9 genotype who have had a recent acute coronary syndrome (ACS). The study has enrolled over 6,000 patients and is being conducted in 680 sites in 32 countries. “The accelerated enrollment of patients in the dal-GenE study reflects the scientific enthusiasm and commitment among the medical community to bring the right medicine to the right patient,” said Dr. Jean-Claude Tardif from the Montreal Heart Institute. “ADCY9 genetic testing to identify the appropriate patients for treatment with dalcetrapib has the potential to provide a genetically targeted therapy to improve clinical outcomes. This approach could pave
Compuware Announces Day One Support for IBM CICS Transaction Server for z/OS V5.514.12.2018 18:02 | Pressemelding
SoftServe Achieves Machine Learning Specialization in Google Cloud Partner Program14.12.2018 13:00 | Pressemelding
Google Cloud recognizes SoftServe’s technical proficiency and proven success AUSTIN, Texas, Dec. 14, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, announces it achieved the Machine Learning Partner Specialization in the Google Cloud Premier Partner Program. The Partner Specialization affirms SoftServe’s expertise and success building customer solutions in the machine learning field using Google Cloud Platform (GCP) technology. The Google Cloud Partner Specialization Program is designed to provide Google Cloud customers with qualified partners that demonstrate technical proficiency in the specialized solution and service areas. Specifically, the Machine Learning Specialization demonstrates SoftServe’s expertise in data exploration, preprocessing, model training, model evaluation, model deployment, online prediction, and Google Cloud’s pre-trained machine learning APIs. “We teach machines to learn, read, see and understand business data, and make
Minerals Technologies Announces Price Increases for Specialty Minerals Products in Europe14.12.2018 00:01 | Pressemelding
NEW YORK, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Specialty Minerals Inc. (“SMI”), a subsidiary of Minerals Technologies Inc., announced today that effective February 1, 2019, it will increase prices by up to 10% for all coated ultrafine precipitated calcium carbonate (PCC) from SMI’s Lifford Specialty PCC facility in Birmingham, UK, subject to individual customer contracts and market provisions. The price increases reflect increased market demand for higher performance materials, as well as significant inflation in input, raw material and logistics costs. About Minerals Technologies Inc. New York-based Minerals Technologies Inc. (MTI) is a resource- and technology-based growth company that develops, produces and markets worldwide a broad range of specialty mineral, mineral-based and synthetic mineral products and related systems and services. MTI serves the paper, foundry, steel, construction, environmental, energy, polymer and consumer products industries. The Company reported sales of $1.