MEDTECH

Halo Labs Launches the Aura GT™ for Gene Therapy Product Quality

Halo Labs | October 05, 2021

Halo Labs, a life science instrumentation company developing tools for biologics researchers, today announced it has launched its latest product, Aura GT.

Aura GT is part of the next generation in Halo Labs' popular family of instruments. Using Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM), Aura GT can distinguish aggregated capsids from contaminants, carrier proteins, and other particles that might adversely harm patients. Unique to Aura GT is the fact that it can also identify DNA leakage in gene therapy products so the mechanism of aggregation can be determined and corrected.

Aura GT is going to completely revolutionize gene therapy product development. Gene therapy products are inherently unstable, which is a huge challenge. Up until now, there has been no effective way to correlate capsid aggregation with DNA leakage or empty and full capsids, In one assay, Aura GT can quantify capsid aggregates, distinguish them from protein aggregates, and determine if the aggregation is exacerbated by DNA leaking.

- Bernardo Cordovez, Chief Science Officer at Halo Labs.

We are very excited to be launching our second instrument this year specifically developed for the cell and gene therapy market, Halo Labs has quickly become a leader in gene therapy analytics because we can answer many questions with very little volume. While other subvisible particle analyzers only do one thing, Aura systems offer a complete multi-assay platform that can be used to fully characterize gene therapy products from early development through lot release.

- Rick Gordon, CEO of Halo Labs.

About Halo Labs
Halo Labs in Burlingame, CA is a venture-backed scientific instrumentation and consumable company that commercializes high throughput biopharmaceutical formulation, stability, and product quality control tools for aggregate and subvisible particle analysis using state-of-the-art custom optics and image processing techniques. Biopharmaceutical companies around the globe depend on Halo Labs for unprecedented insights into their drug products.

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This infographics related to the BT Young Scientist and Technology. 

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This infographics related to the BT Young Scientist and Technology. 

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INDUSTRIAL IMPACT

Vaxess Technologies Announces Grand Opening of GMP Manufacturing Facility

Vaxess Technologies | October 27, 2021

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CELL AND GENE THERAPY

Vipergen Publishes Powerful New Drug Discovery Approach for the First Time, Screening DNA-encoded Small-molecule Libraries (DELs) Inside Living Cells

Vipergen | February 18, 2021

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MEDICAL

Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine

Novavax, Inc. | January 31, 2022

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2. The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile. "We're extremely proud of the work of our teams and we look forward to FDA's review of our EUA request. 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About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. 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The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM). A trial conducted in the U.K. with 14,039 participants was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM. PREVENT-19 is being conducted with support from the U.S. government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is providing up to $1.75 billion under a Department of Defense agreement. About Matrix-M™ Adjuvant Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and generally well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response. About Novavax Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19 vaccine, received Conditional Marketing Authorization from the European Commission, Emergency Use Listing from the World Health Organization, Emergency Use Authorization in Indonesia and the Philippines, and has been submitted for regulatory authorization in multiple markets globally.

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