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Pharmaceutical Technology
图书期刊出版业
Iselin，NJ 5,408 位关注者
Bringing you the latest in global pharmaceutical development and manufacturing industry.
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Pharmaceutical Technology is the authoritative source of peer-reviewed research and expert analyses for scientists, engineers, and managers engaged in process development, manufacturing, formulation and drug delivery, API synthesis, analytical technology and testing, packaging, IT, outsourcing, and regulatory compliance in the pharmaceutical and biotechnology industries.
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https://www.pharmtech.com
Pharmaceutical Technology的外部链接
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- 图书期刊出版业
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Pharmaceutical Technology员工
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Join John McQuaid from Almac Pharma Services to discuss the driving trends shaping the bio/pharma outsourcing market in this instalment of drug digest! Register now: https://ow.ly/aRav50V9u5J
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Is this the future of vaccine technology? Short teaser video, but checkout the full KOL panel discussion when it drops in the week of March 16th here https://lnkd.in/e9qAZevD & https://www.pharmtech.com in tandem with the scientific publication already posted here by Springer Nature , https://lnkd.in/eYE5uWFg In our inaugural "Pivotal Paper" we hear from Vaccine heavyweights Philip Dormitzer MD-PhD, Hospitalist Physician, Coastal Medical Associates , Phil Felgner , PhD, Professor, UC Irvine , Andy Geall PhD, Co-founder and Chief Development Officer, Replicate Bioscience, Inc. - also, Chairman of the board, Alliance for mRNA Medicines , and Jeffrey Ulmer , President, TechImmune LLC The pivotal paper series brings to a wider audience a sharp focus on important advances in the biomedical field. This particular paper comes at an odd time in the vaccine industry (long held as a gold standard in terms of return on investment for producing excellent health outcomes for the lowest capital expenditure possible) currently caught up in culture wars and beset by misinformation and willful ignorance. Self-replicating RNA (srRNA) technology, in comparison to mRNA vaccines, has shown dose-sparing by approximately 10-fold and more durable immune responses. However, no improvements are observed in the adverse events profile. Here, we develop an srRNA vaccine platform with optimized non-coding regions and demonstrate immunogenicity and safety in preclinical and clinical development. Optimized srRNA vaccines generate protective immunity (according to the WHO defined thresholds) at doses up to 1,000,000-fold lower than mRNA in female mouse models of influenza and rabies. Clinically, safety and immunogenicity of RBI-4000, an srRNA vector encoding the rabies glycoprotein, was evaluated in a Phase I study (NCT06048770). RBI-4000 was able to elicit de novo protective immunity in the majority of healthy participants when administered at a dose of 0.1, 1, or 10 microgram (71%, 94%, 100%, respectively) in a prime-boost schedule. Similarly, we observe immunity above the WHO benchmark of protection following a single administration in most participants at both 1 and 10 microgram doses. There are no serious adverse events reported across all cohorts. These data establish the high therapeutic index of optimized srRNA vectors, demonstrating feasibility of both low dose and single dose approaches for vaccine applications. Thanks also to Pharmaceutical Technology , BioPharm International MJH Life Sciences? #vaccine #mRNA #who #infectiousdisease #srRNA #influenza
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Organic Nanoparticle-Based Drug-Delivery Systems as Alternatives to Lipid Nanoparticles, full article here:https://lnkd.in/eWbMisA7 Exploring polymeric nanoparticles: Lipid nanoparticles can include liposomes (lipid vesicles that have at least one lipid bilayer with or without a PEG lipid) and lipid vesicles without a lipid bilayer and comprising multiple lipids, including a PEG lipid and an ionizable lipid designed to deliver messenger RNA. Compared to these LNPs, LG polymer nanoparticles, which have a wide range of tunable properties and performance qualities, can better meet the needs of today’s new modalities, according to Tice. LG polymer tuning includes manipulation of polymer molecular weight, lactide/glycolide ratio for hydrophobicity tailoring, and end-group structures, says Tice. Nanoparticles made with PEG/LG polymers, meanwhile, have PEG molecules oriented on their surfaces to which various molecules can be attached to increase targeting properties and/or active ingredients. Compared to LNPs, LG polymeric nanoparticles can support higher drug loading levels and release drugs over longer periods, Tice observes. In addition, they do not require self-assembly and can be produced using more controlled and scalable processes, such as emulsion-based continuous nanoencapsulation. They are also simpler than LNPs, requiring a single polymer excipient, and can be lyophilized and stored at refrigerator temperatures. There are some challenges to using polymeric nanoparticles for drug delivery. Tice highlights encapsulation of water-soluble drug substances with high encapsulation efficiencies as potentially presenting difficulties. However, the tunability of polymeric nanoparticles often makes it possible to overcome this issue by modifying the polymer properties and developing an appropriate and optimized manufacturing process. He also notes that optimal processes often help address any scaling challenges, with typical batch sizes for clinical trial materials ranging from 1 to 10 kg. Ongoing research is also leading to further progress with polymeric systems designed to mimic the biological compatibility and complexity of therapeutic mechanisms of action, and particularly those that can serve as alternatives to lipid-based drug delivery systems, according to Tice. “The goal is to combine the biological performance advantages of lipid-based systems with the process and manufacturing advantages of polymer-based drug delivery systems,” he states. Huge thankyou to Grant Boldt chief operating officer at CPTx and GXstrands , Davide Zocco , head of exosomes development, Lonza , Tom Tice , senior director global strategic and technical marketing for parenteral drug delivery Evonik Health Care , also Cynthia Challener , Pharmaceutical Technology BioPharm International & MJH Life Sciences? #mRNA #LNP #nanoparticle #exosome #bioprocess #biopharmaceutical
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Joe Payne, Scorpius BioManufacturing, discusses the unique needs of today's biopharmaceutical companies looking to develop and manufacture small-volume, early-stage large molecules. Watch the video: https://ow.ly/IUaG50Vagun
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Join this LIGHTHOUSE Instruments sponsored Virtual Event to learn how to design packaging development studies that enable CCI assurance. Save your seat: https://ow.ly/79t050V67c3
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Inaugural "Pivotal Paper"
Is this the future of vaccine technology? Short teaser video, but checkout the full KOL panel discussion when it drops in the week of March 16th here https://lnkd.in/e9qAZevD & https://www.pharmtech.com in tandem with the scientific publication already posted here by Springer Nature , https://lnkd.in/eYE5uWFg In our inaugural "Pivotal Paper" we hear from Vaccine heavyweights Philip Dormitzer MD-PhD, Hospitalist Physician, Coastal Medical Associates , Phil Felgner , PhD, Professor, UC Irvine , Andy Geall PhD, Co-founder and Chief Development Officer, Replicate Bioscience, Inc. - also, Chairman of the board, Alliance for mRNA Medicines , and Jeffrey Ulmer , President, TechImmune LLC The pivotal paper series brings to a wider audience a sharp focus on important advances in the biomedical field. This particular paper comes at an odd time in the vaccine industry (long held as a gold standard in terms of return on investment for producing excellent health outcomes for the lowest capital expenditure possible) currently caught up in culture wars and beset by misinformation and willful ignorance. Self-replicating RNA (srRNA) technology, in comparison to mRNA vaccines, has shown dose-sparing by approximately 10-fold and more durable immune responses. However, no improvements are observed in the adverse events profile. Here, we develop an srRNA vaccine platform with optimized non-coding regions and demonstrate immunogenicity and safety in preclinical and clinical development. Optimized srRNA vaccines generate protective immunity (according to the WHO defined thresholds) at doses up to 1,000,000-fold lower than mRNA in female mouse models of influenza and rabies. Clinically, safety and immunogenicity of RBI-4000, an srRNA vector encoding the rabies glycoprotein, was evaluated in a Phase I study (NCT06048770). RBI-4000 was able to elicit de novo protective immunity in the majority of healthy participants when administered at a dose of 0.1, 1, or 10 microgram (71%, 94%, 100%, respectively) in a prime-boost schedule. Similarly, we observe immunity above the WHO benchmark of protection following a single administration in most participants at both 1 and 10 microgram doses. There are no serious adverse events reported across all cohorts. These data establish the high therapeutic index of optimized srRNA vectors, demonstrating feasibility of both low dose and single dose approaches for vaccine applications. Thanks also to Pharmaceutical Technology , BioPharm International MJH Life Sciences? #vaccine #mRNA #who #infectiousdisease #srRNA #influenza
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Learn how to break down data silos and effortlessly make data-driven decisions in real time in this webcast sponsored by Altair. Register now: https://ow.ly/Fz8050V5mfB
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