Medicine & Pharmaceuticals News
Marc Malone Receives 2025 Global Recognition Award for Historic Achievement in Multi-Chromosomal Gene Restoration
Marc Malone has earned a 2025 Global Recognition Award for his significant contributions to biomedical research and therapeutic innovation. The scientist achieved a historic milestone by becoming the first person to functionally reverse gene silencing across multiple chromosomes in a living human, done without gene editing techniques. His work establishes a new paradigm in genetic medicine, moving beyond conventional CRISPR-based approaches toward an epigenetic restoration system with demonstrated clinical success. Photo Courtesy of Marc Malone The Global Recognition Awards selection committee utilized the Rasch model evaluation system to establish precise measurements across multiple excellence categories. Malone achieved exceptional scores of 5 out of 5 across research and innovation metrics, including methodology originality, international collaboration, interdisciplinary approaches, technological advancement, and paradigm disruption. His work underwent rigorous evaluation by industry experts focusing on leadership, service, research, innovation, teaching, mentoring, and artistic accomplishments. Innovative Therapeutic Platform Malone's therapeutic system successfully reprogrammed hormonal and tumor suppressor genes, targeting estrogen and progesterone pathways in a treatment-resistant cancer patient. The system could extend beyond oncology applications to include neurodevelopmental and endocrine targets. This development produced the world's first multi-axis gene therapy system that simultaneously targets histones, metabolic inputs, and signaling pathways through what Malone describes as the "triune restoration system." Clinical validation emerged through independent peer review conducted by licensed doctors and respected institutions, including Tempus Labs, and RGCC Onconomics Europe. The results demonstrated an unprecedented tripled lifespan in a patient profile that had never previously been recorded to survive longer than three months. Genetic markers confirmed complete tumor clearance and comprehensive functional clinical recovery, establishing new standards for genetic medicine where conventional gene editing technologies had failed. Scientific Impact and Recognition The research and story achieved virality and millions of views and shares within two months since the paper's preprint publication, through peer interest and patient advocacy networks without professional marketing support. Harvard Medical School doctors, elite academic institutions, oncology researchers, and caregivers worldwide have promoted Malone's work, confirming its credibility within academic circles. Major academic platforms, Google Scholar, and ResearchGate, have indexed the research, with Google AI Overviews referencing it as a "peer-reviewed and clinically evidenced treatment.”. Malone's therapeutic platform addresses global health challenges affecting over one billion people with currently untreatable genetic, neurological, and oncological gene silencing diseases. His comprehensive work encompasses ten human-first advances on record in biomedical science, including terminal refractory TNBC cancer reversal, cancer stem cell inhibition, and chromosomal gene reactivation. The innovation represents a shift from traditional symptom management to addressing root genetic causes of disease across multiple medical specialties. Final Words Malone's personal mission to save his wife and son evolved into a comprehensive therapeutic platform with global implications extending beyond his family's initial crisis. His achievement in reversing gene silencing across multiple chromosomes without traditional gene editing represents significant progress in precision medicine capabilities. The work demonstrates how personal motivation, rigorous scientific methodology, and innovative thinking can produce advances that challenge established medical paradigms. The Global Recognition Awards committee acknowledged Malone's exceptional contribution to advancing human health through innovative research methodology and proven clinical applications. His success in achieving functional gene restoration creates new possibilities for treating previously incurable conditions while opening doors to therapeutic strategies previously considered impossible. "Marc Malone's development in multi-chromosomal gene restoration without editing represents the kind of paradigm-shifting innovation that defines true scientific excellence and humanitarian impact," noted Alex Sterling, spokesperson for Global Recognition Awards. About Global Recognition Awards Global Recognition Awards is an international organization that recognizes exceptional companies and individuals who have significantly contributed to their industry.
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- September 26, 2025Medicine & Pharmaceuticals
Amerigo Scientific Expands Portfolio with High-Performance Catalyst Resins for Industrial Applications
As a leading provider of high-quality research products and equipment for scientific and industrial applications, Amerigo Scientific announced its commercial catalyst resins . These catalyst resins are solid, porous and insoluble polymeric beads prepared to catalyze many types of chemical reactions such as esterification, alkylation, hydrolysis and etherification. “We are committed to providing global clients with innovative tools that enhance efficiency and sustainability in their research and production workflows,” said the business development manager at Amerigo Scientific. “The addition of these high-performance catalyst resins empowers chemists and engineers to optimize their catalytic processes with greater control and a reduced environmental footprint.” Amerigo Scientific’s catalyst resins provide a deep catalog of solid acid and base catalysts that can supplant conventional liquid acids and bases in an array of chemical reactions. Among these resins, there are several merits including easy product separation, low corrosion, less waste generation, and the ability to be reused across multiple reaction cycles. These catalysts find use in applications like esterification, etherification, alkylation, hydrolysis and condensation reaction etc. , making them invaluable for R&D and industrial-scale production in pharmaceuticals, chemicals, and petrochemicals. Complementing the catalyst line, Amerigo Scientific’s high-quality ion exchange resins collection features a wide array of strong/weak acid cation and strong/weak base anion exchangers. These resins are essential for a diverse range of applications such as water treatment, metallurgy, medicine, food, and nuclear industries. The resins are available in various grades, particle sizes, and polymer matrices to meet the precise requirements of complex laboratory and industrial processes. “By consolidating our extensive range of high-performance catalyst and ion exchange resins into dedicated, detailed resources, we are empowering scientists and process engineers to find optimal solutions more efficiently,” stated the business development manager at Amerigo Scientific. “Our commitment is to provide not only premium products but also the technical information necessary to drive innovation and efficiency in our customers' work.”
- September 24, 2025Medicine & Pharmaceuticals
Sustainable IoT Tracking in a Label: OnAsset Launches Sentinel Flex Tag for Global Supply Chain Visibility
OnAsset Intelligence , the trusted leader in intelligent tracking solutions for more than two decades, today announced the launch of the Sentinel Flex Tag , a new smart label for global shipment visibility. Sentinel Flex Tag combines ultra-thin design, temperature and impact sensing, aviation compliance, and AI-powered intelligence to deliver end-to-end visibility for high-value goods. At just 1mm thin, Flex Tag sits flush against cartons and pallets, eliminating the risk of destabilising or damaging stacked shipments. Unlike traditional labels that rely on barcode scanning, Flex Tag integrates autonomous tracking technology in a peel-and-stick form factor, providing easy and seamless deployment without operational disruption. Built for Pharma with Aviation Compliance OnAsset was instrumental in framing the rules for Portable Electronic Devices in air transport. Working with regulatory bodies and airlines, the company helped establish frameworks for real-time tracking devices in aviation to ensure compliance with international regulations. Flex Tag continues this legacy by delivering a fully aviation-compliant solution that works across air, land, and sea without connectivity gaps. A Smart Label That Goes Beyond Location Flex Tag offers more than location tracking. It also includes sensors for temperature and shock, identifying excursions and potential damage. Data from each shipment is processed through OnAsset’s Insight AI Platform, where LISA, the company’s AI shipping agent, monitors shipments around the clock and provides predictive alerts and anomaly detection. This capability enables enterprises to prevent disruption, reduce losses, and improve efficiency by transforming real-time data into predictive insights on how future shipments can be delivered faster, with reduced risk and lower environmental impact. Sustainability at Scale Flex Tag is available in two models. The first is a fully recyclable single-use zinc battery version with up to 30 days of field life. The second is a long-life lithium version with more than 12 months of operation. Each Sentinel Flex Tag is provided with a CO₂ footprint savings certificate, quantifying the reduced environmental impact compared to traditional tracking devices. Meeting Critical Industry Needs The Sentinel Flex Tag has been designed to serve industries where precision, safety, and compliance are essential. In pharmaceuticals and healthcare, it provides assurance for temperature-sensitive drugs and medical equipment. In aerospace and aviation, it safeguards aircraft parts and cargo during transit and storage. In transportation and logistics, it delivers real-time visibility across multimodal networks, while in retail and e-commerce it supports transparency and accurate delivery timelines. Manufacturing companies can also use the device to streamline asset management within Industry 4.0 supply chains. Standing Apart in a Competitive Market The logistics industry has seen many providers offer real-time visibility solutions. OnAsset distinguishes itself through its 20-year history of innovation and development of customer-centric solutions. Sentinel Flex Tag addresses barriers that previously prevented adoption of such technology. Its ultra-thin 1mm form factor allows placement almost anywhere, making it easier to attach than rigid or bulky alternatives. The activation process is as simple as tearing a tab, ensuring shipments are ready in seconds without unnecessary complexity. The device also offers a lower carbon footprint than comparable products, supporting ESG goals and reducing the e-waste generated by disposable trackers. Leadership Perspective Adam Crossno, CEO of OnAsset Intelligence, said: “For more than twenty years, OnAsset has been trusted to track the world’s most valuable goods. The Sentinel Flex Tag represents the next generation of supply chain visibility — ultra-thin, aviation compliant, sustainable, and simple to use.” Paul Rodwell, Head of International Business Development, added: “The simplicity of a peel-and-stick label with the power of OnAsset’s global network is a step change in the industry. Flex Tag makes shipment visibility as straightforward as applying a label.” Availability Flex Tag is available now. Enterprises seeking early adoption can contact OnAsset for more information.
- September 24, 2025Medicine & Pharmaceuticals
Creative Biolabs’ Multi-dimensional Antibody Engineering Platform to Advance Next-Generation Therapeutic Antibody Development
For the industry, the next step in antibody therapeutics is more efficient and more precise immune regulation. Creative Biolabs offers pharmaceutical companies and research institutions comprehensive solutions with strong translational value. ADCC-Enhanced Antibodies: Strengthening Immune Clearance Antibody-dependent cell-mediated cytotoxicity (ADCC) is one of the key effector mechanisms of monoclonal antibodies. However, the natural ADCC activity of antibodies is often limited. Creative Biolabs has developed a series of ADCC-enhanced biosimilars and biobetters . These molecules improve Fc–Fcγ receptor binding efficiency, thereby recruiting immune effector cells more effectively and enhancing cytotoxic responses. This technology has been successfully applied to multiple client antibodies targeting tumor and immune-related antigens, demonstrating significant potential in their early-stage research and drug development programs. Fc-Silent Antibodies: Minimizing Immune Side Effects At the same time, Fc-silent antibodies are attracting increasing attention across the field. In certain therapeutic contexts, the Fc effector function can lead to an over-activation of the immune system and cytokine release syndrome. By leveraging its well-established Fc engineering platform , Creative Biolabs can apply multiple molecular strategies to attenuate or completely abolish Fc interactions with Fcγ receptors and complement C1q, thereby producing truly Fc-silent antibodies. Current offerings include anti-ADDL Fc-silent antibodies, anti-amyloid beta Fc-silent antibodies, and anti-CD146 Fc-silent antibodies, all of which serve as valuable tools for research in neurodegenerative diseases and vascular-related conditions. ADCC Cell Lines: Reliable Systems for Functional Evaluation Besides the optimization of antibody efficacy, robust cell-based systems are critical for successful translational research. Creative Biolabs has established a collection of high-performance ADCC cell lines that provide stable and reproducible platforms for antibody activity assessment. These cell lines are widely used in candidate drug screening, functional validation, and quality control, ensuring a strong technical foundation for downstream development. "We remain committed to providing global clients with antibody engineering solutions that combine innovation with practical applicability," said an antibody research expert at Creative Biolabs in a recent interview. "ADCC-enhanced antibodies and Fc-silent antibodies represent two important directions in therapeutic antibody development—one focusing on amplifying immune effects, and the other on carefully controlling immune activity. When paired with our in-house ADCC cell lines, clients are offered various customizable technical services, which ultimately accelerate the development of next-generation therapeutics." About Creative Biolabs Creative Biolabs has established a strong foundation for cross-disciplinary collaborative research covering diverse areas of diseases. The company will continue to invest in product and service pipeline expansion to translate more promising candidates into the flexible antibody development pathway.
- September 23, 2025Medicine & Pharmaceuticals
Next-Gen Liposomes: Creative Biolabs Expands Stimuli-Responsive Platform
Liposomes have long been renowned for their biocompatibility and ability to encapsulate a wide range of pharmaceutical agents. However, Creative Biolabs is breaking the boundaries of conventional liposome technology by integrating stimuli-responsive materials that allow site-specific drug release. "Think of these liposomes as tiny smart capsules. They're designed to sense changes in the body—like pH changes, enzyme levels, or even external stimuli like heat or electricity—and only deliver the drug when the time and location are precisely optimal. That means fewer side effects and more targeted results, especially for such complex diseases as cancer or diabetes," a researcher at Creative Biolabs said. "Our goal is to provide researchers and pharmaceutical developers with liposomal systems that are not only efficient but also intelligent," said a speaker from Creative Biolabs. "By taking advantage of the unique characteristics of tumor microenvironments and other disease conditions, we can design liposomes to unload their cargo exclusively at the target site, minimizing systemic side effects." Creative Biolabs is ahead of the curve with a portfolio of innovative liposome development services to provide answers to all sorts of stimuli—from glucose levels to ultrasound waves. The following are the company's highlighted services: * Ultrasound-responsive Liposome Development Exploiting thermal and mechanical effects—cavitation and acoustic radiation forces—for enhanced permeability and cellular uptake while preserving the integrity of healthy tissues. *Electro-responsive Liposome Development This strategy allows spatial and precise dosing, which is particularly beneficial in muscular and neurological disease. * ROS-responsive Liposome Development Enhancing this method with the addition of synergistic therapies like photothermal, photodynamic, and sonodynamic therapy, enhancing drug release and therapy while minimizing damage to normal cells. Precision design and material control form the basis of the strategy at Creative Biolabs, allowing the design of liposomes with well-controlled responsiveness. These are tailored to suit the individual needs of every client, whether in drug development or academic research. The platform at Creative Biolabs is for research use only, but it opens up the possibility of clinical uses being explored later. For more information, please visit https://www.creative-biolabs.com/lipid-based-delivery/. About Creative Biolabs Creative Biolabs is a global biotech leader in smart, stimuli-responsive liposome technologies. By utilizing triggers like pH, glucose, and ultrasound, they offer one-stop liposome development services for complex disease research. Their cutting-edge platforms allow researchers to make breakthroughs in targeted therapy and next-generation nanomedicine.
- September 23, 2025Medicine & Pharmaceuticals
Protheragen Expands Global GLP-1 Agonist API Supply to Ease FDA-Listed Shortages
Protheragen, an ISO9001-certified supplier of pharmaceutical ingredients and specialty chemicals, today announced an expanded global supply of GLP-1 agonist APIs , including Semaglutide and Retatrutide, to meet rising demand for diabetes and obesity treatments. Due to the rising global obesity rates and the rapidly growing clinical demand for treatments, pharmaceutical companies are increasingly turning to GLP-1 receptor agonists, which play an important role in both the treatment of type 2 diabetics and weight-management therapies. But according to the U.S. Food and Drug Administration’s (FDA) public drug shortages database, the supplies are now remaining constrained. As a top supplier of various GLP-1 agonist APIs, Protheragen is attempting to ease the shortage. Its enhanced API portfolio now includes fully DMF-supported compounds ( e.g. Semaglutide and Retatrutide), which help clients accelerate regulatory filings and shorten time to market. Additionally, other glucose-lowering APIs such as biguanides, sulfonylureas, and DPP-4 inhibitors are also available for global partners. The Protheragen spokesperson stated, “We always focus on making sure these vital materials reach our partners without delay. And our ISO9001 certification and state licenses guarantee quality and partners know every batch is produced under the toughest quality checks.” The spokesperson added, “As an integrated supplier holding controlled substance distribution and import licenses, we maintain direct oversight of our entire supply chain. This allows us to deliver consistent, reliable batches that meet all compliance requirements time after time.” Considering the use of Tirzepatide in clinical research application for type 2 diabetics and obesity, Protheragen also provides GMP-standard Tirzepatide accompanied by professional technical guidance, regulatory assistance, and customized logistics solutions to further speed up anti-diabetic and anti-obesity research. Protheragen supports its partners in navigating key challenges throughout the entire drug development and production process. For the company, ensuring a reliable supply of APIs is not merely a business objective—it is a commitment to public health. Protheragen prioritizes safety, stringent quality controls, on-time delivery, and regulatory compliance to guarantee that every batch of critical APIs meets the highest industry standards. About Protheragen Protheragen, an ISO9001-certified supplier of pharmaceutical ingredients and specialty chemicals, is dedicated to the development and production of high-quality active pharmaceutical ingredients (APIs) and their key intermediates. Located in New York, the company has an advanced production base and an experienced research and development team, always focused on providing pharmaceutical companies with stable, reliable, and fully compliant with the regulatory requirements of high-quality products and services. With its technical and scientific research strength, it provides reliable products and solutions for the global chemical industry, including chemical products, pharmaceutical excipients, and customized synthesis services.
- September 18, 2025Medicine & Pharmaceuticals
Creative Biolabs Powers Gene Therapy Research with Advanced CRISPR Screening Platforms
As gene therapy keeps transforming the molecular biology world, Creative Biolabs becomes a leader in driving basic research forward with its complete suite of CRISPR-based screening tools . By equipping researchers with robust tools for probing the genome, the company is accelerating discoveries that further unlock the mechanisms of gene function, regulation, and interaction. Gene therapy research relies in large part on precise, scalable technologies to study the genetic determinants of cellular behavior. Creative Biolabs has become a trusted collaborator for biotechnology companies and institutions by offering a range of custom CRISPR screening solutions to suit the different needs of research. At the core of its products is the CRISPR-based screening solutions portfolio, which facilitates high-throughput gene function analysis through knockout (CRISPRko), activation (CRISPRa), and inhibition (CRISPRi) strategies. The platforms allow scientists to globally perturb gene expression and track phenotypic effects, providing important insights into pathways of cell proliferation, stress response, and metabolic regulation. "The genome-wide CRISPR screening service is ideal for large-scale functional genomics studies. With high-coverage sgRNA libraries and best-in-class delivery systems, the service enables unbiased discovery of genes that influence primary cellular processes," a researcher from Creative Biolabs stated. For gene upregulation research, Creative Biolabs offers a specialized CRISPRa screen service that is specialized. This gain-of-function system is employed to activate endogenous genes at their native locations without regard to natural regulatory elements and isoform diversity. It is of significant importance in identifying gene networks that play a role in differentiation, signaling, and transcriptional regulation. "Our CRISPRa screening service is powered by a stringently optimized and quality-controlled process with high accuracy and consistency at every stage—ranging from library preparation of the sgRNA and lentiviral delivery to cell-based screening and comprehensive data analysis," underscore the researcher Creative Biolabs also provides professional consultation, bespoke library design, and data interpretation support to make sure that each project is tailored to the individual goal of the research team. Through its commitment to scientific excellence and innovation, the company continues to develop its services to cater to the evolving requirements of the global research community. "Our purpose is to provide researchers with the tools needed to advance genetic research," said a Creative Biolabs spokesperson. "By offering flexible, high-throughput CRISPR screening services, we empower researchers to develop insightful data that fuels the innovation of gene therapy research." To learn more about Creative Biolabs' gene therapy research services, visit https://www.creative-biolabs.com/gene-therapy/. About Creative Biolabs Creative Biolabs offers innovative CRISPR screening platforms to support gene therapy research. Their tailored solutions help researchers break open the genetic pathways and uncover new insights about gene regulation and cellular activities.
- September 17, 2025Medicine & Pharmaceuticals
CD Bioparticles Launches Advanced Tumor Organoid & CAF Co-culture Service to Accelerate Cancer Research
CD Bioparticles, a leading manufacturer and supplier of numerous drug delivery products and services, has announced the launch of its new Tumor Organoid & CAF Co-culture services to provide researchers with a more physiologically relevant in vitro tumor model, enabling a deeper understanding of tumor-stromal interactions and the development of more effective cancer therapies. Although cancer originates from mutations accumulating within cancer cells, disease progression and treatment response are both strongly regulated by non-mutated cells within the tumour microenvironment. Significant advances have been made in recent years in the study of cancer-associated fibroblasts (CAFs). These cells regulate cancer metastasis by synthesizing and remodelling the extracellular matrix (ECM), as well as secreting growth factors. They also influence angiogenesis, tumour mechanical properties, drug access and therapeutic response. Recent studies have also revealed CAFs' crucial role in modulating the immune system. Targeting intervention by altering CAF numbers, subtypes or functional characteristics is emerging as a novel approach to enhancing the efficacy of cancer treatment. However, this field faces multiple challenges, particularly due to the dual pro-tumour and anti-tumour effects of CAFs. While traditional organoid models can replicate tumour epithelial structures, they lack stromal support, which makes it difficult to fully capture the complexity of tumour behaviour within the native microenvironment. Co-culturing CAFs with tumour organoids enables a more precise reconstruction of the tumour microenvironment and helps to elucidate tumour-stromal interactions. This co-culture system also simulates tumour heterogeneity and evolutionary processes, providing an ideal platform for investigating CAF-mediated drug resistance, immune suppression and barriers to efficient drug delivery. CD Bioparticles now offers comprehensive co-culture services for tumour organoids and CAFs, enabling researchers to construct more precise and dynamic in vitro tumour models. By co-culturing patient-derived tumour organoids with CAFs, CD Bioparticles can help to preserve the intricate interactions between tumours and their stroma. The company also provides flexible options for CAF sources, including cells isolated from tumour tissues, client-provided cells, or commercially available cell lines. For more complex models, the system can be expanded to allow the optional integration of immune or endothelial cells, creating multi-cellular 3D microenvironments. This comprehensive approach is complemented by multidimensional evaluation using functional assays, transcriptomics and imaging analyses to determine the full impact of CAFs on tumour behaviour. By more accurately mimicking the in vivo tumour microenvironment, CD Bioparticles' Organoid & CAF co-culture models can provide valuable insights into important processes such as tumour progression, immune evasion, therapeutic resistance and the efficacy of drug delivery. Consequently, this technology serves as a physiologically relevant in vitro tool that advances tumour biology research and significantly enhances the predictive accuracy of drug screening and delivery assessment platforms. To know more information about these Tumor Organoid & CAF Co-culture services and solutions for cancer therapy development, please visit https://www.cd-bioparticles.net/services/tumor-organoid-caf-co-culture-service.html . About CD Bioparticles CD Bioparticles is an established drug delivery company that provides customized solutions for developing and manufacturing novel biocompatible drug delivery systems. It specializes in various formulation and drug delivery technologies, from conventional liposomes and PEGylated liposomes to polymer microspheres and nanoparticles for drug delivery. The company also provides contract research services for drug delivery formulation, formulation feasibility study, process development and scale-up, as well as analytical and non-clinical research services.
- September 16, 2025Medicine & Pharmaceuticals
CD Bioparticles Introduces Custom Enzyme-Conjugated Particles Services for Advancement in Drug Delivery
With years of experience in the pharmaceutical and life science sectors, CD Bioparticles has announced the launch of its custom Enzyme-Conjugated Particles synthesis services. These particles are primarily polymer- and inorganic-based, and biomolecules and enzymes can be conjugated to them in different ratios for various applications. Due to their unique specificity and high activity, enzymes demonstrate significant potential in therapeutic drug development. However, their broader application is hindered by several limitations, the most significant of which are poor stability, potential immunogenicity and systemic toxicity risks. Considerable attention has been drawn to the use of nanoparticles with exceptional novel properties as enzyme drug carriers due to advances in their synthesis and characterization, as this offers promise in addressing some of these challenges. CD Bioparticles now offers custom particles based on polymeric and inorganic substrates, and targeting biomolecules and enzymes can be conjugated to the particles in different ratios for different applications. Despite their potential, preparing these enzyme-conjugated particles presents several challenges. For example, without preliminary experimental evaluation, it is difficult to predict the functional characteristics of enzymes attached to nanoparticles. Enzymes bound to nanoparticles may undergo partial structural damage, which can result in a significant loss of activity. Additionally, the size of nanoparticles complicates matters by influencing the structure and function of adsorbed proteins. Larger nanoparticles exhibit stronger interactions with proteins, leading to increased denaturation and reduced enzyme activity. CD Bioparticles' enzyme-conjugated particles possess characteristics that help clients to overcome these issues. These particles offer several key advantages. They provide a platform for targeted drug delivery, helping to reduce the systemic toxicity of enzymes. They also have a uniform size distribution and are biocompatible, making them suitable for various applications. The particles can even improve enzyme kinetics by offering a relatively large number of binding sites. One of their most important properties is their ability to enhance the stability of enzymes, which is crucial for therapeutic effectiveness. CD Bioparticles offers custom services to meet clients' different needs, including synthesizing basic particles for delivery, conjugating enzymes or targeting biomolecules, and imparting other necessary characteristics. These custom-engineered particles are suitable for a wide range of applications, including the targeted delivery of vital enzymes such as superoxide dismutase (SOD), anti-inflammatory enzymes and thrombolytic enzymes. They can also be used for affinity-based screening, thereby expanding their utility in research and development. To initiate a project, clients are asked to provide details of their desired application, the type and diameter of the basic particles required, and the necessary functionalization or conjugation specifications (type, density, spacer arm, etc.). Other related information, such as quantity, format and QC material requirements, is also needed to start a custom project. To learn more about Enzyme-Conjugated Particles synthesis services or to contact the CD Bioparticles team for a consultation, quote, or proposal, please visit https://www.cd-bioparticles.com/services/enzyme-conjugated-particles.html . About CD Bioparticles CD Bioparticles is a leading manufacturer and supplier of various nanoparticles, microparticles, and coatings for R&D as well as commercialization across different application areas, including in vitro diagnostics, biochemistry, cellular analysis, cell separation, and immunoassay. The company also offers various custom services, including chemical surface-functionalization, fluorescent modification, antibody immobilization, as well as nucleic acid and oligo conjugation to meet client specifications.
- September 15, 2025Medicine & Pharmaceuticals
STEMart Launches Advanced Bacterial Reverse Mutation Test (Ames) Service to Accelerate Medical Device Safety Assessment
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announced the expansion of its service offerings to include the Bacterial Reverse Mutation Test (Ames) service. This service provides manufacturers and researchers a rapid, cost-effective, and robust method for assessing the mutagenic potential of new chemicals and leachable substances from medical devices, in compliance with the guideline of OECD 471. The bacterial reverse mutation test, commonly known as the Ames test, is a widely used method for detecting bacterial gene mutations. It is favoured for its simplicity, accuracy and low cost. The assay measures the number of colonies formed after exposure to the test chemical. If the bacteria have undergone mutations, the number of colonies formed will be significantly higher than in the negative control cultures. This method is highly sensitive to most genotoxic carcinogens. As a primary screening tool, the Ames test can assess the mutagenic potential of novel chemicals and pharmaceuticals. It is also a mandatory test when submitting registration or approval data to regulatory authorities for diverse chemicals, including pharmaceuticals and biocides. International organizations have established standardized guidelines to ensure that companies and testing laboratories adhere to proper operational procedures. Conducted in accordance with OECD Guidelines for Testing of Chemicals, Test No. 471, the bacterial reverse mutation test (Ames) uses histidine-dependent strains of Salmonella typhimurium or Escherichia coli to detect permanent gene mutations (e.g., single or multiple base pair substitutions, insertions or deletions) caused by new chemicals and candidate drugs. To support the medical device industry, STEMart now provides bacterial reverse mutation test services to evaluate the mutagenic potential of substances leaching from medical devices. This testing can be carried out under GLP (Good Laboratory Practice) or non-GLP conditions. STEMart's Ames test evaluates a substance's mutagenic potential using at least five bacterial strains, including Salmonella typhimurium (e.g., TA97, TA98, TA100, TA102, TA1535 and TA1537) with mutations in the histidine operon and E. coli (e.g., E. coli uvrA and E. coli pKM101) with mutations in the tryptophan operon. The number and set of strains used can be determined based on regulatory requirements. Health regulatory authorities consider this new bacterial reverse mutation test to be the gold standard for predicting a substance's potential to cause cancer in humans. It is highly sensitive and can detect suitable mutants in a wide range of bacteria. A key advantage of the Ames test is its ability to distinguish between direct-acting mutagens and pro-mutagens (substances that become mutagenic after being metabolized). Furthermore, the specificity of the test strains can provide valuable insights into the types of mutations induced by genotoxic agents. STEMart's final reports include a detailed methodology, raw data, analysis and clear results interpretation, ensuring full transparency for clients. To find out more about other medical device testing solutions, or to consult with the experts at STEMart, please visit https://www.ste-mart.com/bacterial-reverse-mutation-test-ames.htm . About STEMart STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. STEMart aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage to manufacturing. STEMart is dedicated to enhancing research and biotech production by providing simpler and safer protocols for better health worldwide.
- September 14, 2025Medicine & Pharmaceuticals
Biotegy Corporation Featured in Report Published by The Icons
Taipei, Taiwan--(Newsfile Corp. - September 13, 2025) - Biotegy Corporation , founded by Dr. Hsu-Wei Fang has recently been featured in a report by The Icons , highlighting a series of important milestones that strengthen Taiwan's position in the global medical technology landscape. Dr. Hsu-Wei Fang leads his team in turning research into medical devices that directly address clinical needs. From material design to regulatory validation, Biotegy Corporation's role is to streamline processes, reduce risks and ensure that outcomes genuinely reach the clinical setting. (Photo: Biotegy Corporation) Biotegy first drew attention for achieving Class II certification for barbed sutures and lifting threads in just over two years, far faster than the typical approval timeline. This achievement demonstrated that locally developed innovation in Taiwan can successfully pass the world's most rigorous scrutiny and enter the market on its own merits. The company soon advanced into higher-level categories, securing two Class III medical device certifications within three years-one for a polylactic acid (PLA) dermal filler and another for a modified-starch haemostatic agent. Both products underwent extensive clinical trials and multi-stage regulatory review. The PLA filler has since been certified internationally and introduced to overseas markets, confirming Biotegy's capability to deliver products that meet global demand. In September 2025, Biotegy made its international debut at the Thailand International Medical Exhibition, one of Asia's leading industry platforms. The company presented its degradable polymer platform and met with distributors, investors, and potential partners from around the world. The exhibition marked a decisive step in Biotegy's global expansion and highlighted Taiwan's growing presence in advanced healthcare solutions. The company's rapid progress is seen as a reflection of Taiwan's transition from a support role in global supply chains to becoming a source of original innovation. By earning high-level certifications, expanding distribution abroad, and gaining visibility through international exhibitions, Biotegy has shown that "Made in Taiwan" medical technology can compete directly at the highest levels of the industry. Commenting on the company's mission, Dr. Hsu-Wei Fang stated: "From the beginning, our goal has been clear: research must not remain in the laboratory-it must reach patients. By achieving certifications and expanding into global markets, we are proving that Taiwan can stand on its own capabilities and deliver world-class medical technology." With its expanding international footprint, Biotegy continues to strengthen Taiwan's position in global healthcare. The company's achievements provide a signal of how domestic innovation can evolve into internationally recognised solutions, contributing to both industry growth and patient outcomes worldwide.
- September 11, 2025Medicine & Pharmaceuticals
Creatine Nitrate Market Trends and Forecasts for 2025: An In-Depth Analysis of Growth Opportunities and Challenges-PW Consulting
The global business landscape continues to evolve rapidly, driven by the growing demand for sports nutrition and advanced performance supplements. Amid this transformative environment, PW Consulting has released an in-depth research report dedicated to the Creatine Nitrate Market, providing stakeholders, investors, and industry professionals with a comprehensive understanding of the forces shaping this dynamic segment. The research begins by outlining the foundational aspects of creatine nitrate, detailing its synthesis and unique benefits compared to more conventional forms of creatine such as creatine monohydrate. The report highlights that creatine nitrate, a compound resulting from the molecular combination of creatine and nitrate, provides enhanced solubility, potentially greater absorption, and improved bioavailability. These properties have led to its rising popularity among athletes and fitness enthusiasts seeking more effective nutrition strategies for muscle growth, strength improvement, and recovery acceleration. One section of the report examines the shifting consumer preferences within the sports nutrition sector. As health consciousness continues to grow globally, the demand for ingredients backed by scientific research has intensified. Consumers now require detailed product information, transparent labeling, and evidence of efficacy. PW Consulting’s research analyzes how creatine nitrate fits into these trends, offering empirical analysis on the adoption patterns among amateur athletes, professional sportspeople, and general wellness communities. Regulatory developments are another focal point of the report. As supplement regulations tighten across North America, the European Union, and some parts of Asia-Pacific, companies are compelled to adapt their formulations and marketing approaches. The report breaks down the current regulatory landscape, emphasizing the importance of compliance, safety protocols, and clinical validation in both product development and positioning. This legal overview is vital to decision-makers planning market entry or expansion. PW Consulting’s investigation into technological innovation addresses the advancements in supplement manufacturing, packaging, and quality control. The report explores how encapsulation technologies, improved extraction methods, and stability enhancement techniques are influencing the purity and potency of creatine nitrate products. Interviews and insights from R&D specialists underscore the role of innovation in differentiating products in a crowded marketplace. A critical part of the report centers around the competitive landscape. Through extensive profiling, the study identifies the key players across the supply chain—raw material suppliers, manufacturers, branded supplement companies, and distributors. The research reveals patterns in mergers, acquisitions, and strategic alliances, shedding light on the consolidation trends that have intensified over the past year. It also discusses how startups, driven by new formulations or functional claims, continue to enter the market and disrupt established brands. Distribution channel analysis forms an integral component of the report. The rise of e-commerce and direct-to-consumer models has transformed traditional retail paradigms. Detailed data illustrates how online platforms now account for a significant proportion of creatine nitrate product sales, enabled by targeted marketing, influencer endorsements, and customizable subscription services. Brick-and-mortar channels, including specialty nutrition stores, gyms, and pharmacies, also maintain relevance through experiential marketing and expert consultation. The report maps the channel strategies adopted by top brands and explores their relative success in different regions. Market segmentation receives substantial attention. PW Consulting investigates the demographics and psychographics of creatine nitrate consumers, segmenting by age, gender, geographic location, activity level, and fitness goals. For example, the report notes a surge in interest among millennials and Gen Z, who are more likely to engage with personalized health and fitness solutions. It also examines the increasing uptake among older adults looking for interventions to support healthy aging and active lifestyles. Further, the report delves into the role of branding, product differentiation, and consumer education in shaping purchasing decisions. Case studies highlight successful product launches that leverage innovative flavors, sustainable packaging, and third-party certifications. Marketing experts interviewed for the report argue that transparent communication of scientific research and clinical results underpins consumer trust and loyalty, especially in a sector often characterized by skepticism and regulatory scrutiny. The research report also casts a spotlight on the challenges facing the creatine nitrate sector. Supply chain vulnerabilities—exacerbated by global events in preceding years—continue to pose significant risks. The report assesses the impact of raw material fluctuations, transportation constraints, and changing trade regulations. In addition, ingredient sourcing and sustainability are rising concerns, with consumers increasingly demanding ethically produced supplements. PW Consulting provides actionable frameworks for navigating and mitigating these risks, drawing on best practices from leading manufacturers and logistics experts. The report investigates regional trends, uncovering how end-user behaviors, regulatory environments, and economic factors vary across major global regions. North America, propelled by a mature fitness culture and high disposable incomes, remains a leader in adoption. Europe’s market is shaped by stringent regulatory standards and a growing emphasis on clean label products. Meanwhile, Asia-Pacific emerges as a hotbed for future growth, driven by expanding urban populations and an uptake in sports and recreational activities. Scientific perspectives are integrated throughout the document, incorporating the latest peer-reviewed research on creatine nitrate’s effects. PW Consulting summarizes findings from clinical trials that assess its efficacy for enhancing athletic performance, improving muscle recovery, and increasing endurance. Nutritionists and sports medicine experts interviewed for the report generally concur that while traditional creatine forms continue to deliver proven results, creatine nitrate’s combination with nitrates may offer distinct advantages, including increased nitric oxide production and improved vascular function. The report evaluates the ongoing academic debates about the optimal dosing, long-term safety, and potential synergies when combined with other performance-enhancing ingredients such as beta-alanine or caffeine. The study also evaluates marketing strategies carried out by leading and emerging brands. Social media campaigns, targeted influencer partnerships, and scientifically-backed content have become fundamental tools for consumer education and engagement. The report shares examples of cross-media marketing initiatives, highlighting the integration of educational webinars, live fitness events, and digital demonstration videos. Additionally, partnerships with sports leagues, gym franchises, and health-focused retail outlets have proved invaluable in building brand credibility and expanding reach. Looking at the next phase of development, PW Consulting’s report provides scenario analysis—outlining best-case, moderate, and adverse scenarios based on current trends and expert forecasts. These scenarios incorporate macroeconomic indicators, regulatory shifts, and consumer sentiment, equipping readers with the tools to anticipate industry fluctuations and plan accordingly. Commentary from sector analysts details the likely impact of inflation, currency shifts, and geopolitical factors on product costs and demand patterns. The expert interviews scattered throughout the document offer unique perspectives from dietitians, formulators, logistics managers, and marketing strategists. These insights help capture the complexity of operating in an industry that must balance rapid innovation, stringent regulation, and shifting consumer preferences. The report emphasizes that a cross-functional approach—combining scientific research, agile supply chain management, and authentic consumer engagement—is essential for sustained success. PW Consulting’s research leverages advanced analytical models, combining both quantitative and qualitative data sources. Proprietary survey data, in-depth interviews, and publicly available datasets are synthesized to offer readers an up-to-date and nuanced portrait of the creatine nitrate ecosystem. The adoption of AI-powered analytics for trend identification and forecasting is presented as a distinctive feature, enabling improved planning and strategic decision-making.
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