Articles
LNPs are composed of different lipids, making quality control easier compared to other types of carriers such as macromolecules or viruses.
During the COVID-19 pandemic, the success of mRNA vaccines has greatly propelled the development of mRNA therapeutics. mRNA is a negatively charged nucleic acid that serves as a template for protein synthesis in ribosomes. Despite its utility, the instability of mRNA necessitates appropriate carriers for in vivo delivery. Currently, lipid nanoparticles (LNPs) are the most mature approach for protecting mRNA from degradation and enhancing its intracellular delivery. To further optimize the therapeutic efficacy of mRNA, researchers have developed a series of site-specific LNPs. Through local or systemic administration, these site-specific L…
During the COVID-19 pandemic, the success of mRNA vaccines has greatly propelled the development of mRNA therapeutics. mRNA is a negatively charged nucleic acid that serves as a template for protein synthesis in ribosomes. Despite its utility, the instability of mRNA necessitates appropriate carriers for in vivo delivery. Currently, lipid nanoparticles (LNPs) are the most mature approach for protecting mRNA from degradation and enhancing its intracellular delivery. To further optimize the therapeutic efficacy of mRNA, researchers have developed a series of site-specific LNPs. Through local or systemic administration, these site-specific L…
Currently, bispecific ADCs are still in the early stages of development globally, with only a few products entering the clinical development stage, and all of them are in early clinical stages.
With the rapid development of antibody-drug conjugate (ADC), more and more companies have entered the field of ADC research and development, and various types of ADC technologies and branches have emerged. Bispecific antibody conjugates (BsAb ADCs) are one of the emerging new technologies. The high specificity of bispecific antibodies enables more precise targeting of tumor cells. On the other hand, promoting the coordinated endocytosis of the two targets through cross-linking can improve the efficiency of toxins entering tumor cells. Currently, bispecific ADCs are still in the early stages of d…
With the rapid development of antibody-drug conjugate (ADC), more and more companies have entered the field of ADC research and development, and various types of ADC technologies and branches have emerged. Bispecific antibody conjugates (BsAb ADCs) are one of the emerging new technologies. The high specificity of bispecific antibodies enables more precise targeting of tumor cells. On the other hand, promoting the coordinated endocytosis of the two targets through cross-linking can improve the efficiency of toxins entering tumor cells. Currently, bispecific ADCs are still in the early stages of d…
Antimicrobial peptides refer to a variety of peptides with inhibitory or bactericidal activity in vivo, usually containing 20-60 amino acid residues with a molecular weight of 2000-7000 Da.
What are Antimicrobial Peptides? Antimicrobial peptides (AMPs) are naturally occurring peptide molecules found in various organisms, including humans, animals, plants, and microorganisms. These peptides play a crucial role in the innate immune system's defense against microbial infections, exhibiting antimicrobial properties that can inhibit the growth or kill bacteria, fungi, viruses, and even some parasites. AMPs possess broad-spectrum activity, targeting various pathogens. AMPs typically rapidly disrupt the integrity of microbial cell membranes, leading to cell lysis and death. This rapid m…
What are Antimicrobial Peptides? Antimicrobial peptides (AMPs) are naturally occurring peptide molecules found in various organisms, including humans, animals, plants, and microorganisms. These peptides play a crucial role in the innate immune system's defense against microbial infections, exhibiting antimicrobial properties that can inhibit the growth or kill bacteria, fungi, viruses, and even some parasites. AMPs possess broad-spectrum activity, targeting various pathogens. AMPs typically rapidly disrupt the integrity of microbial cell membranes, leading to cell lysis and death. This rapid m…
22-Nov-2023
siRNA, with a molecular weight of about 13 kDa, recruits the RNA-induced silencing complex (RISC) to mRNA through base pairing, thereby inhibiting protein translation. The mRNA is targeted for cleavage through the catalysis of the RISC protein Ago2, a member of the Argonaute family. In addition, other Ago proteins (Ago1, Ago3, and Ago4) catalyze endonuclease-mediated degradation of non-specific mRNA by locating the bound mRNA in processing bodies (P-bodies).
Limitations of siRNA as a proprietary drug Naked siRNA is easily degraded by nucleases in blood, and its relatively high molecular weight, negative charge, and hydrophilicity make it difficult to penetrate cell membranes. siRNA tends to accumulate in the kidney and be excreted in urine or is captured by the reticuloendothelial system (…
Limitations of siRNA as a proprietary drug Naked siRNA is easily degraded by nucleases in blood, and its relatively high molecular weight, negative charge, and hydrophilicity make it difficult to penetrate cell membranes. siRNA tends to accumulate in the kidney and be excreted in urine or is captured by the reticuloendothelial system (…
New Gens & Associates research focuses on the evolving role and importance of local affiliates in efforts to make global regulatory processes more consistent and effective through optimised systems and tools. Steve Gens outlines the findings.
Achieving regulatory excellence in Life Sciences companies depends on a combination of process optimisation, effective global systems, high data quality, and better Affiliate collaboration. One weak link in that chain could risk compromising all of the other efforts and investment. Yet highly manual processes, specific local market requirements, and tool usage inconsistencies have often meant a gap in global information visibility and flow which adds risk to key regulatory processes. These processes include submission forecasting and planning; product…
Achieving regulatory excellence in Life Sciences companies depends on a combination of process optimisation, effective global systems, high data quality, and better Affiliate collaboration. One weak link in that chain could risk compromising all of the other efforts and investment. Yet highly manual processes, specific local market requirements, and tool usage inconsistencies have often meant a gap in global information visibility and flow which adds risk to key regulatory processes. These processes include submission forecasting and planning; product…
Heart disease is a leading cause of death in the United States. The Centers for Disease Control and Prevention cite one American dies every 33 seconds because of cardiovascular disease.1 Due to the staggering numbers, heart dysfunction is a well-researched subject. Every finding brings new knowledge to the surface — and one recently led to the discovery of ferroptosis.
Heart disease is a leading cause of death in the United States. The Centers for Disease Control and Prevention cite one American dies every 33 seconds because of cardiovascular disease.1 Due to the staggering numbers, heart dysfunction is a well-researched subject. Every finding brings new knowledge to the surface — and one recently led to the discovery of ferroptosis. Ferroptosis is a form of cell death associated with many…
Heart disease is a leading cause of death in the United States. The Centers for Disease Control and Prevention cite one American dies every 33 seconds because of cardiovascular disease.1 Due to the staggering numbers, heart dysfunction is a well-researched subject. Every finding brings new knowledge to the surface — and one recently led to the discovery of ferroptosis. Ferroptosis is a form of cell death associated with many…
Everyone wants the best outcome possible when they’re a patient or caregiver in the healthcare industry. Technology makes that easier to achieve. The advantages of digitalization enhance the industry’s efficiency, productivity, and quality control. Those in the pharmaceutical industry particularly stand to benefit from digitization. These are the most important ways digital technologies are revolutionizing pharmaceutical manufacturing and the industry as a whole.
Everyone wants the best outcome possible when they’re a patient or caregiver in the healthcare industry. Technology makes that easier to achieve. The advantages of digitalization enhance the industry’s efficiency, productivity, and quality control. Those in the pharmaceutical industry particularly stand to benefit from digitization…
Everyone wants the best outcome possible when they’re a patient or caregiver in the healthcare industry. Technology makes that easier to achieve. The advantages of digitalization enhance the industry’s efficiency, productivity, and quality control. Those in the pharmaceutical industry particularly stand to benefit from digitization…
Specialised commissioning continues to be an issue of significance and uncertainty for both the NHS and industry. What do the latest reports of regional push back on the plans for devolution to Integrated Care Boards (ICBs) mean? Learn more about our upcoming webinar here.
For the past 2 years, Pharma, Medtech, and Diagnostic companies have identified the delegation of specialised commissioning to the new Integrated Care Boards (ICBs) as a key risk to their UK market access strategies. With its importance to income and the high risk of change devolution seems to promise, specialised commissioning is an obvious issue for providers of these products to place at the top of their risk logs. The devolution plans are also a risk for the NHS. Not least, because around two-thirds of the income of a…
For the past 2 years, Pharma, Medtech, and Diagnostic companies have identified the delegation of specialised commissioning to the new Integrated Care Boards (ICBs) as a key risk to their UK market access strategies. With its importance to income and the high risk of change devolution seems to promise, specialised commissioning is an obvious issue for providers of these products to place at the top of their risk logs. The devolution plans are also a risk for the NHS. Not least, because around two-thirds of the income of a…
For the preparation of drug delivery vehicle microspheres, microfluidic technology can produce microspheres in one step without further purification, with very homogeneous particle size and good monodispersity, thus microfluidic technology shows outstanding advantages in the preparation of drug delivery vehicles.
Microfluidic technology enables the preparation of microspheres with good monodispersity and controlled particle size and morphology. Carrier microspheres can be used as drug delivery vehicles to modify the drug release efficiency and improve the accuracy of drug action at the target site. For the preparation of drug delivery vehicle microspheres, microfluidic technology can produce microspheres in one step without further purification, with very homogeneous particle size and…
Microfluidic technology enables the preparation of microspheres with good monodispersity and controlled particle size and morphology. Carrier microspheres can be used as drug delivery vehicles to modify the drug release efficiency and improve the accuracy of drug action at the target site. For the preparation of drug delivery vehicle microspheres, microfluidic technology can produce microspheres in one step without further purification, with very homogeneous particle size and…
Chromatography testing and mass spectrometry are two analytical techniques widely used in scientific research, pharmaceuticals, food safety, environmental analysis, and forensic investigations.
Chromatography testing and mass spectrometry are two analytical techniques widely used in scientific research, pharmaceuticals, food safety, environmental analysis, and forensic investigations. These techniques play a crucial role in identifying and quantifying chemical compounds, determining the purity of substances, and understanding molecular structures. In this article, we will explore the principles, applications, and benefits of chromatography testing and mass spectrometry. Chromatography Testing Chromatography is a powerful separation technique that allows scientists to separate and analyze co…
Chromatography testing and mass spectrometry are two analytical techniques widely used in scientific research, pharmaceuticals, food safety, environmental analysis, and forensic investigations. These techniques play a crucial role in identifying and quantifying chemical compounds, determining the purity of substances, and understanding molecular structures. In this article, we will explore the principles, applications, and benefits of chromatography testing and mass spectrometry. Chromatography Testing Chromatography is a powerful separation technique that allows scientists to separate and analyze co…
In drug delivery systems, marine polysaccharides can be combined with nanotechnology to improve efficacy and safety by controlling the rate, timing, and location of drug release in the body. For example, chitosan-based nanoparticles have been developed to achieve controlled release of cationic drugs, enzyme immobilization support, and encapsulation of bioactive compounds.
Source of Marine Polysaccharides Marine polysaccharides are primarily sourced from a diverse range of marine organisms that thrive in oceans and seas. Seaweeds are the primary and most abundant source of marine polysaccharides. Seaweeds with high polysaccharide content, such as red algae (Rhodophyta), brown algae (Phaeophyceae), and green algae (Chlorophyta), have been extensively studied for their polysaccharide compositi…
Source of Marine Polysaccharides Marine polysaccharides are primarily sourced from a diverse range of marine organisms that thrive in oceans and seas. Seaweeds are the primary and most abundant source of marine polysaccharides. Seaweeds with high polysaccharide content, such as red algae (Rhodophyta), brown algae (Phaeophyceae), and green algae (Chlorophyta), have been extensively studied for their polysaccharide compositi…
Conducting toxicological evaluation helps assess potential risks associated with cosmetic ingredients, ensuring consumer safety.
Cosmetics play a significant role in our daily lives, with millions of people using them to enhance their appearance or maintain their skincare routine. However, the safety of these products should always be a top priority. To ensure the safety and quality of cosmetics, thorough toxicological evaluation, and physical and chemical testing are crucial steps in the development and manufacturing process. Physical and chemical testing of cosmetics is essential to assess their quality and stability. These tests help determine the physical properties and chemical composition of the products, ensuring they meet required standards. One of the most common physical test…
Cosmetics play a significant role in our daily lives, with millions of people using them to enhance their appearance or maintain their skincare routine. However, the safety of these products should always be a top priority. To ensure the safety and quality of cosmetics, thorough toxicological evaluation, and physical and chemical testing are crucial steps in the development and manufacturing process. Physical and chemical testing of cosmetics is essential to assess their quality and stability. These tests help determine the physical properties and chemical composition of the products, ensuring they meet required standards. One of the most common physical test…
In this article, we will explore various types of microneedle patch technologies, including phase-transition microneedle patches, hydrogel microneedle patches, solid microneedles, hollow microneedles, coated microneedles, and dissolving microneedles. Each of these technologies presents unique characteristics and benefits in drug delivery applications.
Microneedle patch technologies have revolutionized the field of drug delivery, offering a wide range of advantages over traditional methods. These innovative patches provide a minimally invasive and painless alternative to injections while ensuring precise and controlled drug administration. In this article, we will explore various types of microneedle patch technologies, including phase-transition microneedle patches, hydrogel microneedl…
Microneedle patch technologies have revolutionized the field of drug delivery, offering a wide range of advantages over traditional methods. These innovative patches provide a minimally invasive and painless alternative to injections while ensuring precise and controlled drug administration. In this article, we will explore various types of microneedle patch technologies, including phase-transition microneedle patches, hydrogel microneedl…
16-Nov-2023
As with antibody detection, the most commonly used antigen detection methods are enzyme-linked immunosorbent assay (ELISA) and lateral flow immunoassay (LFIA).
Antigen Detection Raw Materials An antigen is a molecule (such as protein) that causes the immune system to produce antibodies and trigger an immune response. In the case of COVID-19, structural proteins were found on the surface of SARS-CoV-2 virus. Therefore, it is possible to determine whether a person is infected with virus by detecting the presence of these proteins of the SARS-CoV-2 virus. At present, the authorized antigen detection is mainly to detect the spike or nucleocapsid protein antigen of SARS-CoV-2 virus from nasal swabs or similar clinical specimens to quickly diagnose active infection. Antigen detection is usually l…
Antigen Detection Raw Materials An antigen is a molecule (such as protein) that causes the immune system to produce antibodies and trigger an immune response. In the case of COVID-19, structural proteins were found on the surface of SARS-CoV-2 virus. Therefore, it is possible to determine whether a person is infected with virus by detecting the presence of these proteins of the SARS-CoV-2 virus. At present, the authorized antigen detection is mainly to detect the spike or nucleocapsid protein antigen of SARS-CoV-2 virus from nasal swabs or similar clinical specimens to quickly diagnose active infection. Antigen detection is usually l…
16-Nov-2023
For medical devices, unique device identification (UDI) is a standard requirement. UDI provides a standardized method for identifying and tracking medical devices, offering numerous benefits for patients, healthcare professionals, and the supply chain. It improves quality standards and transforms the medical device industry.
How UDI is Improving Medical Devices The safety and reliability of medical devices is paramount. However, there are times that issues arise, causing safety and other potential concerns. To quickly and efficiently handle these situations when they arise, several practices have been implemented over the years. In 2007, Congress decided that medical devices should not face lengthy recall periods like this. It instructed the Federal Drug Administration (FDA) to…
How UDI is Improving Medical Devices The safety and reliability of medical devices is paramount. However, there are times that issues arise, causing safety and other potential concerns. To quickly and efficiently handle these situations when they arise, several practices have been implemented over the years. In 2007, Congress decided that medical devices should not face lengthy recall periods like this. It instructed the Federal Drug Administration (FDA) to…
In the ever-evolving digital landscape, your frontend is your first and lasting impression. A user-friendly, responsive, and well-maintained frontend is the cornerstone of a successful online presence. Investing in a top-notch frontend web development company, like Appstudio, ensures that your digital storefront is not just open for business but is also welcoming, efficient, and ready to impress.
Did you know that 88% of users are less likely to return to a website after a bad user experience? In the digital realm, where first impressions are everything, the frontend of your website plays a pivotal role. A seamless and visually appealing frontend isn't just eye candy; it's a silent persuader, guiding users through a delightful digital journey. Crafting User-Friendly Interfaces: The Essence…
Did you know that 88% of users are less likely to return to a website after a bad user experience? In the digital realm, where first impressions are everything, the frontend of your website plays a pivotal role. A seamless and visually appealing frontend isn't just eye candy; it's a silent persuader, guiding users through a delightful digital journey. Crafting User-Friendly Interfaces: The Essence…
We are delighted to announce that the second edition of our popular introductory guide: ‘Market access and reimbursement in key European markets’ is now available. Our market access experts have updated the reimbursement routes and added new market insights for 2023/24.
We are delighted to announce that the second edition of our popular introductory guide: ‘Market access and reimbursement in key European markets’ is now available. Our market access experts have updated the reimbursement routes and added new market insights for 2023/24. In this introductory guide, our Global market access experts present an overview of the reimbursement landscape in key European healthcare systems. We highlight the differences between key markets and provide a high-level guide for…
We are delighted to announce that the second edition of our popular introductory guide: ‘Market access and reimbursement in key European markets’ is now available. Our market access experts have updated the reimbursement routes and added new market insights for 2023/24. In this introductory guide, our Global market access experts present an overview of the reimbursement landscape in key European healthcare systems. We highlight the differences between key markets and provide a high-level guide for…
Maria Dimitrova (Consultant – HTA) and Samantha Gillard (Director – HTA) provide an overview of the EU Joint Clinical Assessment (JCA) and what it means for Pharma and Medical Device manufacturers launching new technologies from 2025.
What is the EU JCA? In January 2022, the European Parliament enacted a new EU Health Technology Assessment (HTA) Regulation, with the aim of standardising clinical assessment of medicines and high-risk medical devices across the EU and avoiding duplication of work. Currently, Pharma and Medtech manufacturers have to submit evidence individually in each of the 27 EU markets; the intention of the JCA is that at least some of the assessment can be done centrally. The JCA report will act as a universal information source for relative treatment effects, safety…
What is the EU JCA? In January 2022, the European Parliament enacted a new EU Health Technology Assessment (HTA) Regulation, with the aim of standardising clinical assessment of medicines and high-risk medical devices across the EU and avoiding duplication of work. Currently, Pharma and Medtech manufacturers have to submit evidence individually in each of the 27 EU markets; the intention of the JCA is that at least some of the assessment can be done centrally. The JCA report will act as a universal information source for relative treatment effects, safety…
10-Nov-2023
Broughton expands analytical testing services with a one-stop solution for Extractables and Leachables
To help pharmaceutical and consumer healthcare companies bring their products to market safely and efficiently, scientific consultancy and contract research organization (CRO) Broughton has launched a new Extractables and Leachables (E&L) testing service. Regulatory bodies increasingly focus on the interactions between manufacturing components, drug delivery devices and container-closure systems (CCS), and the final product formulation. Producers must identify and assess any toxicological risks that could arise via such interactions. Broughton’s new service will offer tailored E&L studies with a fully integrated approach that combines technical and analytical services, in-house to…
To help pharmaceutical and consumer healthcare companies bring their products to market safely and efficiently, scientific consultancy and contract research organization (CRO) Broughton has launched a new Extractables and Leachables (E&L) testing service. Regulatory bodies increasingly focus on the interactions between manufacturing components, drug delivery devices and container-closure systems (CCS), and the final product formulation. Producers must identify and assess any toxicological risks that could arise via such interactions. Broughton’s new service will offer tailored E&L studies with a fully integrated approach that combines technical and analytical services, in-house to…
Clinion has secured the top spot on the list of Clinical Trial Management Solutions for the year 2023
Austin, TX — November 08, 2023 Clinion is Named as The Top Clinical Trial Management Solution Provider of 2023 by Medhealth Review We are proud to announce that Clinion has secured the top spot on the list of Clinical Trial Management Solutions for the year 2023. This remarkable recognition underscores our commitment to transforming the landscape of clinical trials with cutting-edge AI-enabled technology. At Clinion, we’ve always aimed for excellence, and this achievement is a testament to our dedication to providing innovative solutions that streamline and enhance the entire clinical trial process. Our fully integrated eClinical software platform, equipped with EDC, IWRS/RTSM, CTMS, ePRO,…
Austin, TX — November 08, 2023 Clinion is Named as The Top Clinical Trial Management Solution Provider of 2023 by Medhealth Review We are proud to announce that Clinion has secured the top spot on the list of Clinical Trial Management Solutions for the year 2023. This remarkable recognition underscores our commitment to transforming the landscape of clinical trials with cutting-edge AI-enabled technology. At Clinion, we’ve always aimed for excellence, and this achievement is a testament to our dedication to providing innovative solutions that streamline and enhance the entire clinical trial process. Our fully integrated eClinical software platform, equipped with EDC, IWRS/RTSM, CTMS, ePRO,…
