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Avirmax CMC Successfully Delivers First GMP Lot of AAV Vector Product for Clinical Trial Use

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HAYWARD, Calif., July 17, 2024 /PRNewswire/ — Avirmax CMC, a leader in the innovation and manufacture of adeno-associated virus (AAV) vector-mediated biotherapeutics, announces the successful delivery to its first client with Good Manufacturing Practice (GMP) lots of AAV vector product trial use.

Avirmax CMC Inc. Successfully Delivers GMP Lots of AAV Vector Products for Client’s Phase I/IIa Clinical Trial in the US

This milestone marks a significant achievement in Avirmax CMC’s mission to provide high-quality gene therapy solutions. The GMP-compliant AAV vectors were produced using Avirmax’s state-of-the-art VSaf™ rBV-Sf9 technology platform, which ensures high titers at extremely low empty capsid ratio, and enhanced expression of the gene of interest (GOI). The delivered vector product will play a crucial role in the upcoming clinical trial, aimed at treating ocular diseases.

“Our team at Avirmax CMC is thrilled to have reached this pivotal point in our journey. Delivering to our first customer with GMP lot of AAV vector product underscores our commitment to excellence and our capability to meet stringent regulatory standards and customer’s satisfaction,” said Dr. Shengjiang Shawn Liu, CEO & CSO of Avirmax CMC Inc. “We are dedicated to advancing gene therapy development for partners and making these innovative treatments accessible to patients in need.”

The GMP AAV product lots were produced, tested and packaged at Avirmax CMC’s cutting-edge facility in the City of Hayward, the heart of San Francisco Bay Area, which is equipped with single use technologies for scalable and robust manufacturing processes. The production process ensures that the vector products meet the highest standards of quality and safety required for clinical use.

The successful delivery of this GMP lot demonstrates Avirmax CMC’s readiness to support clinical trials and contribute to the development of effective gene therapies. The company’s focus on innovation and quality positions it as a key player in the biopharmaceutical industry.

About Avirmax CMC Inc.

Avirmax CMC is dedicated to the innovation, development, and manufacture of AAV vector-mediated biotherapeutics. Based in the San Francisco Bay Area, the company leverages its proprietary technologies to deliver safe, effective, and affordable gene therapy solutions. Avirmax CMC’s mission is to advance gene therapy and improve the lives of patients with ocular and CNS diseases. For more information about Avirmax CMC and its services, please visit Avirmax CMC’s website (https://www.avirmaxcmc.com/).

Contact

June Song, Associate Director for Operations
Email: business@avirmax.com
Tel: +1-510-641-0201

Address
25503 Whitesell Street
Hayward, CA 94545
USA

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A-LIGN Issues First ISO 42001 Certification to Synthesia

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TAMPA, Fla., Sept. 25, 2024 /PRNewswire/ — A-LIGN, the leading provider in cybersecurity compliance, has issued its first unaccredited ISO/IEC 42001 certification to Synthesia, marking a groundbreaking achievement in artificial intelligence (AI) compliance.

The issuance of Synthesia’s ISO 42001 certificate highlights A-LIGN’s unwavering commitment to excellence and its role in empowering clients to achieve and maintain the highest levels of compliance in the ever-evolving AI landscape.

“AI is revolutionizing our world, driving change in both business operations and regulatory frameworks,” said Patrick Sullivan, VP of Strategy & Innovation at A-LIGN. “At A-LIGN, we are dedicated to innovation through services like ISO 42001, ensuring our clients receive the trusted quality they expect as the AI landscape evolves. This commitment enables industry leaders like Synthesia to leverage compliance as a strategic advantage.”

London-based Synthesia is the first AI video company to achieve ISO 42001 compliance. This certification sets a new benchmark in the industry, showcasing Synthesia and A-LIGN’s joint dedication to compliance innovation and high-quality security.

“Synthesia is committed to the responsible, transparent, and secure development of AI technologies, and achieving ISO 42001 certification through A-LIGN’s audit process demonstrates our dedication to these principles,” said Martin Tschammer, Head of Security at Synthesia. “A-LIGN’s expertise and attention to detail helped us identify and remediate any gaps in our rigorous processes. Together, we have led the way for the rest of the industry in the adoption of this standard, fostering trust and ensuring the long-term success of AI development and use.”

For more information about A-LIGN and ISO 42001 certification services, visit https://www.a-lign.com.

About A-LIGN
A-LIGN is the leading provider of high-quality, efficient cybersecurity compliance programs. Combining experienced auditors and audit management technology, A-LIGN provides the widest breadth and depth of services including SOC 2, ISO 27001, HITRUST, FedRAMP, and PCI. A-LIGN is the number one issuer of SOC 2 and a leading HITRUST and FedRAMP assessor. To learn more, visit a-lign.com.

About Synthesia
Synthesia is the world’s leading enterprise AI video communications platform. More than 55,000 businesses, including half of the Fortune 100, use it to communicate efficiently and share knowledge at scale using AI avatars. Founded in 2017, Synthesia is headquartered in London and makes video creation, collaboration and sharing easy for everyone. Learn more at https://synthesia.io/.

Media Contact: Abigail Rodrigues, abigail.rodrigues@a-lign.com

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Vanderbilt University School of Medicine Basic Sciences Adds Carterra’s LSAXT Instrument to Speed Drug and Vaccine Research and Advance Patient Care

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The Center for Structural Biology in the School of Medicine Basic Sciences will be a hub of research innovation using Carterra’s platform in traditional and AI-driven workflows for characterizing both antibodies and other biomolecules

SALT LAKE CITY and NASHVILLE, Tenn. , Sept. 25, 2024 /PRNewswire/ — Carterra® Inc., the world leader in innovative technologies enabling high-throughput biology, and the Vanderbilt University School of Medicine Basic Sciences announced today the addition of the Carterra LSAXT label-free interaction analysis platform to the Center for Structural Biology (CSB). Vanderbilt and Vanderbilt University Medical Center researchers will be able to discover and characterize large molecules including antibodies.

“Many of our researchers are trying to identify antibodies that bind to a protein involved in health or disease,” said Borden Lacy, director of the CSB and Edward and Nancy Fody Chair in Pathology and professor of biochemistry and pathology, microbiology and immunology. “The ability to rapidly screen and quantify binding for large libraries of antibodies will shape the way molecular discovery moves forward at Vanderbilt. The work we spend months on will now be completed in a matter of days. It is incredibly exciting.” 

Carterra’s LSA platform was used by pharmaceutical giant Eli Lilly during the COVID-19 pandemic to find antibodies effective against SARS-CoV-2. Within 90 days of isolating antibodies from an early COVID-19 survivor, Lilly was in clinical trials with the world’s first COVID-19 therapeutic, the antibody Bamlanivimab.

BAM, as it became known, is the fastest drug ever discovered and saved countless lives.  The publication in Science describing the feat concluded, “The resulting speed at which this drug discovery and development effort progressed…is a testament to the advanced discovery and characterization platforms.”

Vanderbilt investigators will now be able to leverage the Carterra platform for a variety of research aims. 

Two projects that are getting early traction include:

Stephanie Wankwicz, assistant professor of molecular physiology and biophysics and a faculty affiliate of the Center for Applied AI in Protein Dynamics, is elucidating the role of entropy in substrate specificity and catalysis.  Wankowicz is planning to use Carterra’s platform to more quickly and efficiently analyze a large panel of peptide sequence variants against a kinase. Older methods are very low throughput and would require high concentrations of the protein/peptide solution.

Brian Wadzinski, associate professor of pharmacology, recently submitted a grant application to characterize pan- and phosphor-specific nanobodies for investigating MAPK and PP2A signalling. Affinity measurements for these large panels of nanobodies and high-resolution epitope binning can only be performed on Carterra’s platform.

The LSAXT instrument includes hardware and software features that build upon the capabilities of Carterra’s original and highly successful LSA instrument while maintaining its impressive throughput and sample efficiency. The LSA platform delivers 100 times the data in 10 percent of the time-to-answer and uses only 1 percent of the sample required by other label-free platforms.

Just last year, Vanderbilt launched the Center for Applied AI in Protein Dynamics which will also benefit from the addition of Carterra’s platform.  The LSA® is the only label-free biosensor that can generate enough data, quickly and efficiently, to train algorithms and learning models used to predict the affinity and epitope coverage of drug candidates. Pharmaceutical and biotech companies who have now moved to AI-driven drug discovery workflows have standardized on the LSA.

Vanderbilt has always led its peers in research innovation,” commented Tim Germann, Chief Commercial Officer at Carterra. “To enable the use of AI in antibody discovery and characterization by adding the LSAXT to its stable of technologies cements Vanderbilt’s position as the academic leader in this rapidly evolving research landscape.”

Since its launch in 2018, Carterra’s interaction analysis platform has penetrated 19 of the largest 20 pharmaceutical companies, major universities and vaccine makers, contract research organizations (CROs), and biotechs on four continents. Characterizing binding kinetics and epitope coverage of large numbers of antibodies in early research has been transformative. The LSA platform has been profiled in multiple Science, Nature, and Cell peer-reviewed papers.

Media Contact:
Cheri Salazar, Sr. Marketing Manager
Carterra, Inc.
(408) 594-9400
Csalazar@carterra-bio.com 

About Carterra, Inc.
Carterra® is privately held and is the leading provider of high-throughput technologies designed to accelerate and improve the discovery of novel therapeutic candidates. Carterra’s LSA® instrument, software, and consumables for biotherapeutic discovery and characterization deliver up to 100 times the throughput of existing platforms in 10% of the time while using only 1% of the sample required by other systems. The LSA combines patented microfluidics technology with real-time high-throughput Surface Plasmon Resonance (HT-SPR) and industry-leading data analysis and visualization software to revolutionize mAb screening. The new LSAXT provides enhanced optics to enable additional applications in biotherapeutic discovery and characterization. Carterra, Inc. is based in Salt Lake City, Utah, and has Customer Experience Centers in San Francisco, Salt Lake City, Boston, Manchester, England, and Munich, Germany. Carterra products are available in Asia-Pacific and Oceania through our exclusive distributor, Revvity. For additional information, please visit www.carterra-bio.com.

About the Vanderbilt Center for Structural Biology
The Vanderbilt Center for Structural Biology promotes the broad use of structural biology approaches in all life science research and provides resources for education and training in state-of-the-art technologies. Uniquely, the CSB merges applications of high resolution structural biology disciplines, X-ray crystallography, NMR spectroscopy, cryo-electron microscopy and computational biology, with the biophysical instrumentation needed to characterize biomolecular interactions. This strategy allows researchers to solve fundamental structural problems in medicine and biology. The CSB facilitates collaborations with investigators across a range of Departments in both the College of Arts and Science, the School of Medicine Basic Sciences, and the School of Medicine in Vanderbilt University Medical Center. The CSB is directed by Borden Lacy, Edward and Nancy Fody Chair in Pathology and professor of biochemistry and pathology, microbiology and immunology.

Photo – https://mma.prnewswire.com/media/2515106/Canterra_LSAXT_HT_SPR.jpg
Logo – https://mma.prnewswire.com/media/2491466/Carterra_Logo.jpg

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BMC Helping Customers Improve Lives and Customer Experiences in Healthcare, Financial Services and Energy Sectors

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NHS Northumbria patients, Nationwide Building Society members, and EDP customers benefit from the time- and cost-savings BMC delivers using data-driven insights and automation

HOUSTON, Sept. 25, 2024 /PRNewswire/ — BMC, a global leader in software solutions enabling business faster than humanly possible, has collaborated with European leaders in the healthcare, finance, and energy industries to optimize their IT and operational technology (OT) investments and realize the benefits of DataOps and ServiceOps for millions of their patients and customers.

NHS Northumbria, Nationwide Building Society, and Energias de Portugal (EDP) use the Control-M solution from BMC and the BMC Helix platform to gain data-driven insights instantly across complex hybrid IT environments, saving costs while drastically improving the speed and reliability at which they deliver value.

NHS Northumbria accelerates patient care with BMC Helix

Northumbria NHS Foundation Trust is among the largest healthcare organizations geographically in the U.K., with around 12,000 employees serving around 500,000 people in northeast England. Delivering a full range of health services across 10 main sites, including an emergency care hospital, general and community hospitals, and other facilities, the Trust seeks to improve patient outcomes and relieve pressure on its people and processes.

Using BMC Helix to digitize its end-user experience, NHS Northumbria has achieved:

90% paperless SLA improvement400% increase in Digital Workplace platform adoptionSignificant ROI within the first three yearsImproved patient processing times, real-time decisions, and secure authorizations from any device

“To achieve big things, you must develop the ability to get small things right, too. In our team, we ensure that excellence in everything is not an exception. It’s more of an attitude, and BMC shares those values,” said Glen Foster, Deputy Director for Service Delivery, Performance and Governance, Northumbria Healthcare NHS Foundation Trust. “We’ve already improved care levels—now we aim to build out trust rating beyond outstanding and see what digital transformation can deliver.”

Nationwide Building Society meets high financial standards with BMC Helix Capacity Optimization

Based in the U.K., Nationwide is the world’s largest building society, with 16 million members. Nationwide decided to upgrade from its custom on-premises system to a cloud solution that could handle the organization’s complex IT estate, and selected the BMC Helix Capacity Optimization solution, which delivers robust forecasting, modeling, and extrapolation functionalities that made it stand out.

With the BMC Helix Capacity Optimization solution, Nationwide has:

Met regulatory requirements 6 months ahead of scheduleEnabled three months advanced notice for potential capacity issuesReduced requests forwarded to ITOps by 94%

“If we want to stand by the decisions we’re making, we’ve got to trust the data. Now, the data is in BMC Helix Capacity Optimization, so the system can consolidate and highlight what’s pertinent. Getting to this point was critical,” said Peter Norris, Process Owner for IT Service Demand and Capacity Management at Nationwide.

EDP powers the energy market with Control-M

As a global company, EDP relies on a wide range of business services to drive innovation and provide support to customers worldwide, including energy production, distribution, and management. To simplify, automate, and standardize the production of millions of invoices per day and ensure that accurate invoices were created, printed, and shipped on time, every time, EDP chose Control-M, the market-leading application and data workflow orchestration platform from BMC.

With this solution, EDP has:

Serviced nine million customersExperienced a 46% reduction in application workflow execution incidentsReduced requests forwarded to ITOps by 36%

“Control-M runs hundreds of applications and covers nearly all of our business in EDP. If anyone from the Application Teams or Process Architecture Teams comes to us with an integration request or other challenge, Control-M can always offer a solution,” said Carlos Miguel Pereira, Head of Scheduling Platform and Operations Management at EDP.

Additional resources

Learn more about BMC customers here

About BMC

BMC empowers 86% of the Forbes Global 50 to accelerate business value faster than humanly possible. Our industry-leading portfolio unlocks human and machine potential to drive business growth, innovation, and sustainable success. BMC does this in a simple and optimized way by connecting people, systems, and data that power the world’s largest organizations so they can seize a competitive advantage.

BMC, BMC Software, the BMC logo, and other BMC marks are the exclusive properties of BMC Software, Inc. and are registered or may be registered with the U.S. Patent and Trademark Office or in other countries. 

©Copyright 2024 BMC Software, Inc.
www.bmc.com

Editorial Contact
Madeline Bien
BMC
ExtComms@bmc.com

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