Artificial Intelligence
Drug Product Filled with Berkshire Sterile’s Low Loss Fill Process Receives FDA Greenlight
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Lee, MA, May 18, 2023 (GLOBE NEWSWIRE) — RNAimmune, a biotech company focused on developing groundbreaking mRNA therapies, recently received FDA approval to begin Phase 1 clinical studies for an investigational new drug (IND). The drug product was supplied by Berkshire Sterile Manufacturing, using their new low-loss fill process. The process was key to overcoming product sensitivity challenges and reducing drug product loss to supply product for clinical studies in time.
BSM’s low loss fill process was designed and validated in 2022 to limit drug product loss for high-value medicines, and it features several additional advantages, including low shear, high repeatability, and excellent precision.
RNAimmune contracted BSM to fill an oligonucleotide therapy encompassed in a proprietary lipid nano particle (LNP). The product is exceptionally shear-sensitive and demonstrated degradation from shear forces in both peristaltic and piston pumps.
Unlike a standard sterile fill finish project, the low loss fill process does not use a pump in filling. Instead, sterile drug product is filled utilizing a low-shear, time-pressure filling system. The process is entirely isolator-based and offers less than 30mL of drug product loss (including losses from formulation, filtration, and filling). In addition to excellent repeatability and accuracy, the process requires significantly less operator interaction than traditional hand-pipetting.
BSM also developed a formulation and sterile filtration process to further reduce shear. During formulation, BSM enveloped RNAimmune’s active pharmaceutical ingredient (API) in their proprietary LNP and optimized the removal of the organic solvent and the sterile filtration process to reduce shear.
“We are excited to see the positive impact that our low loss fill process has for RNAimmune’s product,” said Shawn Kinney, CEO of Berkshire Sterile Manufacturing. “Our goal is to provide innovative solutions to ensure our clients receive the highest quality drug products with the greatest product yield possible. The BSM team welcomed the challenge and delivered what the customer wanted.”
“We are happy about the collaboration with the Berkshire Sterile Manufacturing team. The IND clearance from the FDA will allow us to investigate RV-1730 as an effective vaccine booster with the potential to provide continued protection against COVID-19,” said Dong Shen, MD, PhD, founder and President of RNAimmune. “This study is expected to provide preliminary data on the safety, tolerability, and immunogenicity of RV-1730’s technology when using a vaccine construct that targets the SARS-CoV-2 variants.”
Berkshire Sterile Manufacturing has filled two successful GMP lots for RNAimmune, and the CDMO expects to further improve their capabilities for oligonucleotides, LNP projects, and small-scale, low-volume drug product filling.
About Berkshire Sterile Manufacturing:
Berkshire Sterile is a state-of-the-art fill finish contract manufacturer specialized in small-scale sterile filling of vials, syringes, and cartridges for biotech and pharmaceutical industries. BSM also offers terminal steam sterilization of syringes, specialty filling, and lyophilization of vials all within isolators. Analytical support, stability studies, lyophilization development, formulation development, and method development are also offered. For more information, please visit the company’s website (https://berkshiresterilemanufacturing.com/) or contact them at [email protected].
About RNAimmune:
RNAimmune is an international biopharmaceutical company focusing on mRNA vaccine and therapeutics development. Its global headquarter is in Germantown, Maryland, USA, while the China headquarter is in International BioIsland, Guangzhou. RNAimmune has received a global exclusive right to the proprietary Polypeptide Lipid Nanoparticle (PLNP) technology for mRNA delivery from Sirnaomics. In addition, RNAimmune has various independent proprietary R&D platforms, including linearized, circular, and self-amplified mRNA platforms, next-gen lipid nanoparticle (LNP) delivery system, and polymer delivery system. RNAimmune developed artificial-intelligence enabled algorithms which cover neoantigen prediction, nucleic acid sequence optimization, next-gen lipid design and prediction. RNAimmune has various vaccines
and therapeutics programs, including vaccines for infectious diseases (COVID-19, influenza, RSV and HSV etc.) and cancer vaccines (KRAS, NY-ESO-1), mRNA encoded antibodies, and protein replacement medication. In April 2023, RNAimmune received FDA clearance of investigational new drug application for phase 1 trial of RV-1730 COVID-19 booster vaccine. RNAimmune has extremely high potential and has become one of the leading companies in the field of mRNA vaccines and therapeutics. Learn more at: www.rnaimmune.com.
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Artificial Intelligence
Aetina Accelerates Embedded AI with High-performance, Small Form-factor Aetina IA380E-QUFL Graphics Card
TAIPEI, April 25, 2024 /PRNewswire/ — Aetina, a leading Edge AI solution provider, announced the launch of the Aetina IA380E-QUFL at Embedded World 2024 in Nuremberg, Germany. This groundbreaking product is a small form factor PCIe graphics card powered by the high-performance Intel Arc A380E GPU.
Unmatched Power in a Compact Design
The Aetina IA380E-QUFL delivers workstation-level performance packed into a low-profile, single-slot form factor. This innovative solution consumes only 50W, making it ideal for space and power-constrained edge computing environments. Embedded system manufacturers and integrators can leverage the power of 4.096 TFLOPs peak FP32 performance delivered by the Intel Arc A380E GPU[1].
Beyond Small Size: Big Capabilities
Despite its compact size, the IA380E-QUFL offers native support for 4 mini-DisplayPort outputs and 6GB of GDDR6 memory, enabling the connection of multiple high-resolution displays (UHD). This makes the IA380E-QUFL an excellent choice for a wide range of applications, including commercial gaming, video walls, medical imaging, and visual inference for smart cities.
“The demand for slim and energy-efficient AI systems is rapidly escalating,” said Jackal Chen, Senior Product Manager at Aetina. “The Aetina IA380E-QUFL addresses this need head-on, offering a powerful GPU solution in a compact, single-slot form factor with minimal power consumption. This empowers developers to create powerful and efficient edge systems for a wide range of applications.”.
Unparalleled Commitment: 5-Year Product Supply
Acknowledging the critical need for long-term product stability in industrial applications, Aetina ensures a 5-year product supply for the Aetina IA380E-QUFL, which streamlines system roadmaps and reduces the need for costly redesign. Our commitment is aligned with Intel’s announced product plans for the Intel Arc A380E GPU.[1]
[1]https://www.intel.com/content/www/us/en/content-details/820389/intel-arc-gpu-for-the-edge-public-30-3-30.html?wapkw=Intel%20Arc%20GPU%2030-3-30&DocID=820389 Intel, the Intel logo, and other Intel marks are trademarks of Intel Corporation or its subsidiaries.
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Meta description : Explore IG Canada’s advanced trading platform, educational resources, and robust security features. Achieve your trading goals with the innovative tools.
NOTTINGHAM, England, April 25, 2024 /PRNewswire/ — IG Canada, a premier online trading platform, is pleased to announce significant enhancements to its trading technology, designed to empower both novice and experienced traders with superior tools and resources. This development is part of IG Canada’s commitment to providing the best trading experience in the Canadian market.
IG Canada has upgraded its platform with advanced features that streamline trading processes and improve the accuracy of trade execution. These enhancements include customizable charts, a wider range of indicators, and improved mobile access, ensuring traders can operate efficiently from anywhere at any time.
Recognizing the importance of education in trading success, IG Canada has expanded its educational resources. The brokerage now offers a comprehensive learning center featuring webinars, tutorials, and articles that cater to various skill levels. These resources are designed to help traders develop robust trading strategies and improve their market knowledge.
Security remains a top priority for IG Canada. The latest updates include enhanced encryption and multi-factor authentication to protect client data and funds. These security measures provide peace of mind for traders, knowing their investments are safeguarded against potential threats.
IG Canada is a leading online brokerage that provides trading services across multiple asset classes, including forex, stocks, commodities, and indices. With a focus on innovation and customer service, IG Canada is committed to helping Canadian traders achieve their investment goals through a transparent and efficient trading environment.
In addition, IG Canada is committed to engaging with the community through upcoming webinars, live events, and partnerships with local financial experts. These initiatives are designed not only to support the growth and education of the clients but also to foster a stronger, more connected trading community in Canada.
Press Contact:Contact Name: Timothy C. SherwinEmail: [email protected] Phone: +447 441425053
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Artificial Intelligence
Sentrycs Now Part of the UK National Protective Security Authority Catalog of Security Equipment
This inclusion into the NPSA CSE marks a significant milestone in the company’s commitment to enhancing national and international airspace security and to leading the C-UAS market toward multi-layer strategy optimization and excellence.
TEL-AVIV, Israel, April 25, 2024 /PRNewswire/ — Sentrycs, a leading innovator in adaptive counter-drone solutions, is proud to announce its inclusion in the prestigious UK National Protective Security Authority Catalogue of Security Equipment (NPSA CSE).
Following a rigorous assessment process, Sentrycs’ cutting-edge Counter Unmanned Aerial Systems (C-UAS) solution has met the high standards set by the NPSA for Detection, Tracking, and Identification (DTI). The testing, conducted at the NPSA’s designated testing facilities in August 2023, rigorously evaluated the Sentrycs system against the NPSA’s DTI Testing and Evaluation Standard v3.1.
Sentrycs elected to be assessed under Configuration D as a 3D system with Ground Control Station (GCS) detection capability and platform identification capability, which is the most demanding test scenario with the highest number of scored parameters.
The Sentrycs system demonstrated exceptional capabilities in various security scenarios, showcasing its robustness in detecting and tracking with high accuracy and zero false alarms. The system’s innovative use of cyber techniques to extract data from targets and its streamlined human-machine interface were especially noted for their efficiency and ease of use.
“Our team is proud to have Sentrycs recognized by the UK National Protective Security Authority,” said Yoav Zaltzman, CEO of Sentrycs. “Being listed in the CSE is not just an honor; it’s a testament to our technology’s reliability and effectiveness in contributing to the ever-changing airspace security landscape.”
Sentrycs’ technology is now accessible through the NPSA CSE, providing security practitioners with verified solutions that meet the UK’s rigorous security standards. This inclusion not only underscores Sentrycs’ role in advancing security technology but also enhances its visibility and credibility on a global stage.
For more details on Sentrycs’ solutions and their impact, visit www.sentrycs.com.
For further information regarding the NPSA and the Catalog of Security Equipment, please visit the NPSA’s official website.
About Sentrycs
Sentrycs is a leader in adaptive counter-drone solutions, supported by innovative technology designed to passively identify, mitigate, and where necessary, intercept unauthorized drones custom-built for various environments – including airports, borders, prisons, critical infrastructure, and mass events. Founded in 2017, Sentrycs’ has offices in Israel and the US, serving customers worldwide. By uniting its field-proven technology and expertise in global drone environments, Sentrycs is leading the way towards a safer and more secure drone-driven future. Learn more at www.sentrycs.com
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