GlobeNewswire by notified

Alphalyse and Bavarian Nordic A/S significantly shorten the time necessary to document HCP impurities in COVID-19 vaccine candidate for Phase 3 clinical trial – through world’s first MS-based HCP analysis under GMP conditions

Share

ODENSE, Denmark, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Alphalyse has performed the world’s first GMP-certified mass spectrometry (MS)-based Host Cell Protein (HCP) analysis for product release testing for Phase 3 clinical trial, after being certified by the Danish Health and Medicines Authority to perform quality control of biological API using MS-based HCP analysis under GMP.

On September 2, 2022, Bavarian Nordic A/S announced the start of Phase 3 clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate. ABNCoV2 is being developed as a universal booster to any other type of COVID-19 vaccine and has shown potential to boost neutralizing antibodies against SARS-CoV-2, including variants of concern, to levels associated with a high degree of protection. The goal is to create a longer-lasting vaccine protection with broader efficacy that obviates the need for continuously adapting to new variants of the SARS-CoV-2 virus. The development of ABNCoV2 is being funded through an agreement with the Danish State, and the Danish Ministry of Health has committed DKK 800M to support the ongoing Phase 3 clinical trial. Prior to the Phase 3 clinical trial, Bavarian Nordic contracted Alphalyse to perform product release testing under GMP conditions, thereby becoming the first pharmaceutical company in the world to use MS-based HCP analysis for Phase 3 clinical trial documentation.

One of the biggest challenges in developing vaccines is ensuring and documenting that the downstream process consistently produces a safe product with low HCPs levels. Alphalyse offers a unique LC-MS-based HCP analysis, used for more than 300 biotherapeutic projects, which is significantly faster than traditional methods for product impurity documentation and enables pharmaceutical companies to identify and eliminate specific process-related impurities, thereby further increasing the quality, safety, and efficacy of their product. This makes the Alphalyse method particularly useful for developing vaccines during a global pandemic when the time to create a process-specific ELISA is limited.

The unique Alphalyse method has the potential to significantly reduce the time required to document new vaccines, from the current industry standard of 12-18 months to as little as 4 months, while being as safe or safer than other methods.

Thomas Kofoed, co-founder and Chief Executive Officer of Alphalyse, says: “This is a major milestone, not only for Alphalyse, but for the many companies struggling with the limitations of ELISA. With the potential for using mass spectrometry as a release assay, we can assist developers with short time frames, such as those producing vaccines during a pandemic, and very complex products, such as cell and gene therapies, in getting their HCP release assay in place for Phase 3 clinical trial and for marketed products.”

About Alphalyse
Alphalyse is a specialist contract research organization that supports biopharmaceutical companies in developing and manufacturing patient-safe products, such as mAbs, vaccines, recombinant proteins, and cell and gene therapies. Alphalyse has offices in Denmark and the USA, supporting clients with the analysis of protein-related impurities and protein characterization, and has completed more than 10,000 customer projects since 2002.

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing, and commercialization of life-saving vaccines. Using their live virus vaccine platform technology, MVA-BN®, they have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including the development of a next generation COVID-19 vaccine.

Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

For more information, please contact
Thomas Kofoed, CEO, Alphalyse
Phone: +45 6310 6501
US office: (650) 543-3193
Email: kofoed@alphalyse.com

Distributed on January 3, 2023.

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified 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.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Iveco Group signs a 150 million euro term loan facility with Cassa Depositi e Prestiti to support investments in research, development and innovation11.6.2024 12:00:00 CEST | Press release

Turin, 11th June 2024. Iveco Group N.V. (EXM: IVG), a global automotive leader active in the Commercial & Specialty Vehicles, Powertrain and related Financial Services arenas, has successfully signed a term loan facility of 150 million euros with Cassa Depositi e Prestiti (CDP), for the creation of new projects in Italy dedicated to research, development and innovation. In detail, through the resources made available by CDP, Iveco Group will develop innovative technologies and architectures in the field of electric propulsion and further develop solutions for autonomous driving, digitalisation and vehicle connectivity aimed at increasing efficiency, safety, driving comfort and productivity. The financed investments, which will have a 5-year amortising profile, will be made by Iveco Group in Italy by the end of 2025. Iveco Group N.V. (EXM: IVG) is the home of unique people and brands that power your business and mission to advance a more sustainable society. The eight brands are each a

DSV, 1115 - SHARE BUYBACK IN DSV A/S11.6.2024 11:22:17 CEST | Press release

Company Announcement No. 1115 On 24 April 2024, we initiated a share buyback programme, as described in Company Announcement No. 1104. According to the programme, the company will in the period from 24 April 2024 until 23 July 2024 purchase own shares up to a maximum value of DKK 1,000 million, and no more than 1,700,000 shares, corresponding to 0.79% of the share capital at commencement of the programme. The programme has been implemented in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (“MAR”) (save for the rules on share buyback programmes set out in MAR article 5) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. Trading dayNumber of shares bought backAverage transaction priceAmount DKKAccumulated trading for days 1-25478,1001,023.01489,100,86026:3 June 20247,0001,050.597,354,13027:4 June 20245,0001,055.705,278,50028:6 June20243,0001,096.273,288,81029:7 June 20244,0001,106.174,424,68

Landsbankinn hf.: Offering of covered bonds11.6.2024 11:16:36 CEST | Press release

Landsbankinn will offer covered bonds for sale via auction held on Thursday 13 June at 15:00. An inflation-linked series, LBANK CBI 30, will be offered for sale. In connection with the auction, a covered bond exchange offering will take place, where holders of the inflation-linked series LBANK CBI 24 can sell the covered bonds in the series against covered bonds bought in the above-mentioned auction. The clean price of the bonds is predefined at 99,594. Expected settlement date is 20 June 2024. Covered bonds issued by Landsbankinn are rated A+ with stable outlook by S&P Global Ratings. Landsbankinn Capital Markets will manage the auction. For further information, please call +354 410 7330 or email verdbrefamidlun@landsbankinn.is.

Relay42 unlocks customer intelligence with a new insights and reporting module, powered by Amazon QuickSight11.6.2024 11:00:00 CEST | Press release

AMSTERDAM, June 11, 2024 (GLOBE NEWSWIRE) -- Relay42, a leading European Customer Data Platform (CDP), is leveraging Amazon QuickSight to power its new real-time customer intelligence, reporting, and dashboard module. Harnessing the breadth and quality of customer data, the new Insights module empowers marketing teams to dive deep into customer behaviors and gain invaluable insights into the performance of their marketing programs across all online, offline, paid, and owned marketing channels. Preview of the Relay42 Insights module, in pre-beta version Key capabilities of the Relay42 Insights module include: Deep insights into customer behaviors: With the Relay42 Insights module, marketers can ask unlimited questions about their data and gain a deeper understanding of how to serve their customers more effectively. Simplicity with AI-powered querying: Marketers can use artificial intelligence to query their data using natural language search, reducing the reliance on data scientists. Us

Metasphere Labs Announces X Spaces Event on the Topic of Green Bitcoin Mining and Sound Money for Sustainability11.6.2024 10:30:00 CEST | Press release

VANCOUVER, British Columbia, June 11, 2024 (GLOBE NEWSWIRE) -- Metasphere Labs Inc. (formerly Looking Glass Labs Ltd., "Metasphere Labs" or the "Company") (Cboe Canada: LABZ) (OTC: LABZF) (FRA: H1N) is thrilled to announce an engaging Twitter Spaces event on Green Bitcoin mining, energy markets, and sustainability on July 3, 2024 at 2 p.m. ET. Follow us on X at MetasphereLabs for updates and to join the event. What We'll Discuss Bitcoin Mining Basics: Understand the fundamentals of Bitcoin mining.Energy Market Dynamics: Explore how Bitcoin mining interacts with energy markets.Sustainable Innovations: Learn about our efforts to promote sustainability in Bitcoin mining.Sound Money: Discover how tamper-proof currency can enhance stability.Efficient Payment Rails: See how fast, neutral payment systems support humanitarian projects.Carbon Footprint: Compare Bitcoin's environmental impact with traditional banking. "We're excited to host this event and dive into the critical topics of Bitcoin

World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye