Articles
Ensure faster trials, regulatory compliance, and real-time oversight with Clinion's innovative eTMF software. In the dynamic world of clinical research, efficient management of data and documents is crucial. Clinion's Electronic Trial Master File (eTMF) simplifies this process by providing a centralized platform for storing, organizing, and tracking all your clinical trial essentials. Key Benefits:Rapid Deployment: Start quickly with pre-built models and a configurable structure, reducing setup time to weeks. Intuitive Interface: Clinion's eTMF utilizes industry-standard DIA TMF Reference Models for a user-friendly experience, allowing for ef…
In recent years, microneedle patches have emerged as a revolutionary technology in the beauty and skincare industry. These patches are designed to deliver active ingredients directly into the skin, providing targeted treatments for a variety of concerns. One area where microneedle patches have shown significant promise is in the treatment of the delicate skin around the eyes and lips. In this article, we will explore the latest innovations in microneedle eye and lip patch technologies, including advancements in manufacturing processes and delivery methods. Microneedle Eye and Lip Patch Microneedle patches for the eyes and…
The field of pharmaceuticals has seen rapid advancements in drug delivery technologies in recent years, one of which is long-lasting controlled-release microspheres technology. This technology involves the use of microscopic particles to deliver drugs in a controlled and sustained manner over an extended period of time. By encapsulating drugs within these microspheres, pharmaceutical companies are able to improve patient compliance, reduce dosing frequency, and enhance therapeutic outcomes. In this article, we will explore the benefits and applications of long-lasting controlled-release microspheres technology. Long-…
Polymers play an important role in the biomedical field, and polyethylene glycol (PEG) and its derivatives are among the multifunctional polymers that have attracted much attention. PEG is a synthetic macromolecule with a linear structure consisting of glycol units (-CH2CH2O-) repeatedly linked. Its unique properties give PEG a wide range of applications. PEG is soluble in organic solvents and water has excellent physicochemical and physi…
In 2024, Applicant Tracking Systems (ATS) continue to be the linchpin of a successful recruitment strategy, offering a blend of technological prowess and user-friendly interfaces to streamline the hiring process. The talent acquisition landscape is brimming with hundreds of HR and recruitment platforms all claiming to be the ultimate solution for anyone hiring top talent. But which ones are truly the most ef…
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In the latest instalment of our Diversity, Equity & Inclusion Leadership series, we spoke to Ankit Mahadevia, MD, Founder and Chair of Spero Therapeutics, and author of Quiet Leader, Loud Results[1]. Ankit talks about the value of cultural diversity, authenticity and trust, drawing on his sixteen years' experience creating and leading Life Science companies. Coulter Partners: Please share your personal journey. Ankit Mahadevia: I'm th…
The chemical industry applies lipid analysis and characterization in creating specialty chemicals and polymers. Lipids can serve as raw materials in polymer chemistry. For instance, lipid-based monomers can be polymerized to produce high-value pla…
To begin with, SN38-BSA is composed of SN38, a potent anti-cancer drug, and BSA or Bovine Serum Albumin. SN38 is the active metabolite of the prodrug irinotecan, commonly used in chemotherapy. It's known for its high potency against cancer cells but has limitations in terms of bioavailability and solubility. BSA, on the other hand, is a protein derived from cows that has found extensive uses in biochemistry, including as a carrier protein for drugs. Bioconjugate chemistry is the chemical bonding of two biomolecules, enabling them to create hybrid molecules with new…
AAV Formulation Development: A Primary Focus In the field of gene therapy, AAV formulation development has gained significant focus. AAV vectors are used as delivery vehicles or "vectors" to administer therapeutic genes into patient's cells. This therapeutic gene, once inside the cell, generates a functional protein to correct or counter the effects of the disease-causing genetic mutation, providing a basis for curing several genetic diseases. The AAV's natur…
Mycotoxins are toxic secondary metabolites produced by certain fungi. They can contaminate a wide range of commodities, from grain to dried fruits, spices, coffee, and cocoa. They represent a genuine health risk for both humans and animals, causing various diseases referred to as mycotoxicoses. Certain mycotoxins are carcinogenic, immune-suppressing, neurotoxic, or cause damage to organs like the liver. Hence, reducing and controlling mycotoxin levels in food products is of utmost importance. One possible wa…
Whole Slide Imaging: Whole slide imaging, commonly known as virtual microscopy, revolutionizes the way pathology specimens are analyzed by digitizing entire tissue slides for comprehensive examination. This technology involves scanning various whole slides digitally in high resolution, stitching together images derived from each field of view across the complete microscopy slide using specialized software. The result is a single digital image file that can be stored safely for archiving and documentation, benefiting the consulting and teaching industries. This cutting-edge technology allows pathologists to view high-resolution images of entire t…
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Click chemistry has revolutionized the field of bioconjugation, offering a robust and versatile approach for linking biomolecules, such as proteins, peptides, nucleic acids, and carbohydrates, to create novel materials and probes. Traditionally, copper-catalyzed azide-alkyne cycloaddition (CuAAC) has been the cornerstone of click chemistry, but concerns about cytotoxicity and metal contamination have sparked increasing interest in copper-free alternatives. This article explores the diverse applications of copper-free click chemistry in biomedical research, hig…
Medical devices encompass simple devices such as tongue depressors, bandages, and syringes to imaging devices (ultrasound and CT scanners), implantable devices (pacemakers), and medical equipment. The emergence and technological advancements in of data analytics, artificial intelligence (AI), and increased internet connectivity and…
It would be possible to put a stop to counterfeit medicines. However, simple controls are often still lacking. That's why researchers want to help drug detectives. In 2015, health officials in the northern region of the Democratic Republic of the Congo stated that they had seen unexplained symptoms in hundreds of children, including convulsions, vertigo, and an erect posture. An emergency team was dispatched by Médecins sans Frontières (Doctors Without Borders) in response to a possible meningitis outbreak. Nevertheless, none of the patients have meningitis infections discovered by the investigators. The children's urine samples…
A Chemistry, Manufacturing, and Controls (CMC) Specialist plays a crucial role in the pharmaceutical and biotechnology industries by ensuring that all aspects of the product development process related to chemistry, manufacturing, and controls meet regulatory standards and guidelines. The primary function of a CMC Specialist is to oversee and guide the development, manufacturing, and testing processes of drugs or biologics to ensure product quality and compliance with regulatory requirements. This involves a d…
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As AI continues to evolve and integrate into various fields, the life sciences industry has begun leveraging this transformational technology to revolutionise regulatory affairs. Given the complexity and volume of regulatory requirements that companies must comply with, AI offers a promising solution to streamline processes and enhance accuracy. In this article, we delve into how AI is currently used within regulatory affairs in the life sciences, a…
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Regulatory affairs professionals play a pivotal role in ensuring that pharmaceuticals, biologics, medical devices, and other life science products comply with all the relevant regulations. Their work is crucial to bringing safe and effective products to market and safeguarding public health. For those aspiring to venture into this field, understanding the top skills required is a vital first step.…
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What is Polyethylene Glycol? Polyethylene glycol is a high molecular polymer with the chemical formula HO(CH2CH2O)nH. It is non-irritating, has good water solubility, and has good compatibility with many organic components. It has excellent lubricity, moisturizing, dispersion and adhesion. It can be used as antistatic agent and softener in cosmetics, pharmaceuticals, chemical fibers, rubber, plastics, papermaking, paints, electroplating, pesticides, metal processing and food. It has a wide range of applications…
In the intricate landscape of the life sciences, the function of regulatory affairs stands as a linchpin, ensuring not only the seamless introduction of innovative medical solutions to the market but also their compliance with stringent legal and ethical standards. This realm of expertise, pivotal to the pharma…
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Clinical trials are complex endeavours that rely on meticulous data collection, efficient communication, and rigorous oversight. Two critical software systems underpin these needs: Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS). This post explores why seamless integration between EDC and CTMS is paramount for effective trial management. What are EDC and CTMS? EDC (Electronic Data Capture): Imagine a digital filing cabinet for clinical trial data. EDC systems streamline participant data collection, ensuring accuracy and regulatory compliance. CTMS (Clinical Trial Management System): Think of CTMS system as t…