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BIOTECHNOLOGY
Medical Device News Magazine reports breaking biotechnology news in addition to medical device news.
Lonza Launches Innovaform™ Accelerator, the New Innovation and Formulation Center in Colmar (FR)
Christian Seufert, President, Capsules & Health Ingredients, Lonza, commented: “The Innovaform™ Innovation and Formulation Accelerator represents a unique solution for drug developers seeking to solve complex dosage form and delivery challenges through innovation.
NanoVation Therapeutics Announces Multi-Target Partnership with Novo Nordisk to Develop Genetic Medicines Targeting Cardiometabolic and Rare Diseases
Under the terms of the agreement, Novo Nordisk and NanoVation Therapeutics will collaborate on two lead programs to develop base-editing therapies for certain rare genetic diseases, and up to five additional future targets for cardiometabolic and rare diseases.
Circular Genomics Announces Launch of MindLight, the 1st SSRI Antidepressant Response Test Using Brain-Derived Biomarkers
MindLight is the first circular RNA biomarker-based assay designed to predict whether a patient with depression, also known as major depressive disorder, will respond to selective serotonin reuptake inhibitor (SSRI) antidepressant treatment.
EDETEK Announces New Insights on Conducting End-to-End Clinical Trial Solutions
This session, entitled, "Transforming Clinical Trials: From Reactive to Predictive," takes place during the DPHARM Innovative Collaborations Track C, on Tuesday, September 17, 2024, at 4:10pm EDT reports Edetek.
AliveDx Receives IVDR-CE Mark for Multiplexed Assay to Accurately Detect Celiac Disease on the MosaiQ® System
"We are thrilled to obtain the CE mark for our MosaiQ AiPlex CD microarray," said Manuel O. Mendez, CEO of AliveDx. "The MosaiQ fast portfolio expansion marks our fourth microarray CE mark approval in the last 12 months reflecting our dedication to rapidly advance diagnostic technologies and our commitment to support the millions of individuals affected by autoimmune diseases. Early and accurate diagnosis is crucial for managing this condition. Our innovative MosaiQ microarray solutions represent a significant advancement to partner with laboratorians and clinicians to reduce healthcare costs and improve patient outcomes and quality of life."
PHC Unveils Prototype of LiCellGrow, New Cell Expansion System to Support Development of Cell and Gene Therapy Products Manufacturing Process
PHC Corporation Biomedical Division (Headquarters: Chiyoda-ku, Tokyo; President: Nobuaki Nakamura, hereinafter referred to as "Biomedical Division") will showcase a prototype of its new cell expansion system LiCellGrow at the ISCT (International Society for Cell & Gene Therapy) Europe 2024 Regional Meeting held in Gothenburg, Sweden on September 4-6.
WuXi Biologics Successfully Completes First Scale-Up of High-Productivity Bioprocessing Platform WuXiUI™ in 2,000L GMP Manufacturing
By leveraging its ultra-intensified fed-batch platform, WuXiUI™, WuXi Biologics has completed its first scale-up to 2,000L drug substance (DS) GMP manufacturing, achieving a 4-fold productivity improvement compared to the traditional fed-batch process. The competitive performance achieved through the utilization of both WuXiUI™ and the proprietary platform cell culture media MagniCHO™ led to significant reduction in overall DS manufacturing COGS
The consistent performance of WuXiUI™ – from small scales to 2,000L GMP manufacturing – is a testament to the advancement of the technology as a mature and robust platform capable of significantly improving the cost-effectiveness of biologics production
PCI Pharma Services In Bedford, New Hampshire Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection
The new ICMRA program is designed to abbreviate the time necessary to receive regulatory approvals from multiple countries. Regulatory agencies from several countries can convene for one inspection as a team, allowing CDMOs such as PCI Pharma Services to attain approval from each of the participating ICMRA countries simultaneously rather than undergo separate, phased inspections.
Partillion Bioscience Announces Early Access Program for Nanovial Multicell Assays to Enable the Study of Cell-to-Cell Interactions
"Our Nanovial Multicell Assays are a game-changer, opening up new possibilities in research areas where the precise colocalization of cells is essential for studying complex cell-to-cell interactions or screening for therapeutic molecules released by one cell that act on another" said Joe de Rutte, Co-founder and CEO of Partillion. "By enabling these complex screens, all using standard life science instrumentation, we're enabling scientists to scale studies of how cells interact with other cells, whether it's better understanding tumors in the context of immune cells in their microenvironment, host-pathogen interactions or developing the next-generation therapies."