Research and development - Articles

The fast-tracking landscape of contemporary gene therapy demands continuous advances in AAV (Adeno-associated virus) formulation development and the enhancement of cGMP (Current Good Manufacturing Practice) capacity. Together, these transformations are essential in producing safe and effective gene therapies for patients.
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 and GMP fermentation are two key components to consider in today's food and beverage industry. With the increasing demand for high-quality and safe food products around the globe, it's important to understand the significance of these aspects in the production process.
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…

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.
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…

Polyethylene glycol 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 processing and other industries.
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 today’s competitive clinical research landscape, seamless EDC-CTMS integration is not simply a convenience; it’s a strategic imperative
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…

In 2020, the global landscape changed dramatically with the advent of COVID-19. The fatal virus strain soon infected millions of people worldwide, forcing everyone to live a masked life that became limited to their homes.
Problem Statement In 2020, the global landscape changed dramatically with the advent of COVID-19. The fatal virus strain soon infected millions of people worldwide, forcing everyone to live a masked life that became limited to their homes. Bharat Biotech is one of India’s leading Biotech companies and when India got hit by the COVID-19 pandemic, the company started looking for a proven and easy-to-use system that could accelerate COVID vaccine trials. Bharat Biotech’s Covaxin, one of the first COVID-19 vaccines developed by an Indian company, was approved to enter Phase 1…

Hannah Palin (Director – Market Access) and Calum Jones (Associate Director – Health Economics) explore the landscape for economic evaluation in the US. They highlight important considerations for companies seeking to infiltrate this key market.
Health economic modelling is fundamental to market access, in both health technology assessment (HTA) and pre and post-launch engagement. It is of value globally, but holds particular importance in markets across Europe, the UK, and Canada, among others. Its application in the US, however, is less established. With a dedicated Health Economics Team, economic modelling is a key area in which Mtech Access support clients. Whilst there are variations in the approaches between HTA markets, we can see commonalities in the requirement for e…

Urethral strictures pose a significant clinical challenge, impacting millions of individuals worldwide and often requiring complex and invasive treatments. In recent years, there has been growing interest in developing novel therapeutic approaches to address urethral strictures, with a particular focus on regenerative medicine and tissue engineering techniques.
Urethral strictures pose a significant clinical challenge, impacting millions of individuals worldwide and often requiring complex and invasive treatments. In recent years, there has been growing interest in developing novel therapeutic approaches to address urethral strictures, with a particular focus on regenerative medicine and tissue engineering techniques. Among these emerging strategies, decellularization stands out as a promi…

Clinion's Clinical Trial Management System (CTMS) gives enhanced visibility into all aspects of the clinical trial process - from study plan, Remote monitoring, and Clinical data management.
Clinion CTMS is an integrated Clinical Trial Management System (CTMS) designed to give Contract Research Organizations (CROs) and Sponsors greater visibility and control over their clinical trials. Here's a breakdown of its key features and benefits: Real-time Visibility: Gain a comprehensive view of your entire trial at any time. This allows for faster decision-making and course correction, potentially accelerating study timelines. Reduced Trial Costs: Clinion CTMS helps streamline workflows, automate tasks, and optimize spending. This can lead to significant cost savings by minimizing redun…

510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc.
People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device which is on the market. 510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to…

Particles (or powder) in tablets can occasionally experience sticky punch phenomena that prevent the particles from flowing smoothly into the mold wells. Lubricants are mostly utilized in solid preparations, particularly pills and capsules.
IntroductionParticles (or powder) in tablets can occasionally experience sticky punch phenomena that prevent the particles from flowing smoothly into the mold wells. As a result, particles in tablets before are frequently required to add a small amount of lubricating effect of the material, in order to increase mobility and decrease friction with the die, and to ensure a clean and attractive tablet surface. These substances are typically referred to as lubricants. Lubricants are mostly utilized in solid preparations, particularly pills and capsules. Mech…

Monopotassium phosphite provides essential nutrients for plant growth and helps to promote healthy roots and overall plant development.
Monopotassium phosphite is a chemical compound with the molecular formula KH2PO3. It is a salt of phosphorous acid and is commonly used as a fertilizer in agriculture. Monopotassium phosphite provides essential nutrients for plant growth and helps to promote healthy roots and overall plant development. It is also known for its ability to enhance plant resistance to diseases and stress. Action Principle of Potassium Dihydrogen Phosphite Phosphite is a highly mobile molecule that can be easily absorbed by the leaves and roots of plants and moved throughout the plant. Therefore, phosphite can be used by foliar spraying and irrigation fertilization, and is…

Stability analysis consists of different methods such as influencing factors analysis, long-term accelerated shelf-life testing, and light stability analysis, each of which plays a significant role in determining the stability and shelf-life of pharmaceutical products.
In the field of pharmaceutical science, stability analysis plays a crucial role in ensuring the safety and efficacy of pharmaceutical products. It is a complex and multifaceted process that requires thorough investigation and understanding of various influencing factors. Stability analysis consists of different methods such as influencing factors analysis, long-term accelerated shelf-life testing, and light stability analysis, each of which plays a significant role in determining the stability and shelf-life of pharmaceutical…

Investing in life science companies is both challenging and rewarding. The sector is constantly evolving and comes with a lot of unknowns and risks, especially at the commercialisation stage. However, with the potential to help create a positive impact to society and simultaneously receive financial gains, it can be an incredibly worthwhile venture.
Investing in life science companies is both challenging and rewarding. The sector is constantly evolving and comes with a lot of unknowns and risks, especially at the commercialisation stage. However, with the potential to help create a positive impact to society and simultaneously receive financial gains, it can be an incredibly worthwhile venture. Launched in May 2022 by thriving life science community Discovery Park, Discovery Park Ventures…

Optimize your clinical trials with Clinion RTSM software the easy-to-use and innovative solution that puts patient safety and accurate randomization first
We at Clinion are excited to share our all-in-one Randomization and Trial Supply Management (RTSM) software designed to streamline clinical trial operations! Effortless Integration: Our RTSM seamlessly integrates with our EDC platform. Randomize patients and assign investigational product kits directly within the same system, eliminating the need to switch between applications and reducing the risk of data entry errors. Flexible Randomization Power: Clinion's RTSM caters to diverse study designs. Whether you require simple randomization or complex stratified/minimization approaches, our software can handle it! Real-ti…

AI is transforming medical coding by improving coding accuracy. In this blog, we’ll explore what this transformation means for clinical trial organizations.
Accuracy in medical coding is a vital aspect in aiding clinical trial operation success. It has presented an excellent opportunity for medical coders, working hand-in-hand with AI-enhanced computer-assisted coding systems, to quickly identify and validate the correct codes. Using natural language processing (NLP) and advanced Machine Learning algorithms, AI is transforming medical coding by improving coding accuracy. In this blog, we’ll explore what this transformation means for clinical trial organizations. What is Medical Coding? Medical coding is a critical process that involves assigning standardized codes to medical terms in clinic…

Clinion electronic data capture (EDC) software uses AI to simplify Study Build and set up your study in days instead of weeks with an easy-to-use interface
The Freedom And Flexibility To Built Studies On Your Own Clinion Electronic Data Capture (EDC) Software uses AI and Automation to simplify Study Build, Data Capture and Clinical Data Management (CDM). With advanced features like Medical Coding Automation, External Data Load, Visit Scheduling, Bulk locks, CRF versioning as part of a standard package Clinion makes things simpler for its users. Integrate Clinion Electronic Data Capture (EDC) Software with Clinion CTMS, IWRS/RTSM, and ePRO/eCOA for true end-to-end support of your Study, obviating the hassles of data reconciliation while dealing with multiple eCl…

Research from Teva Pharmaceuticals shows that Europe’s critical medicine cabinets – in hospitals, pharmacies, and homes – are home to fewer generic medicines. These are the often-cheaper alternatives to brand name medicines, that make up 67%[1] of all medicines.
Amsterdam, 3 April 2024 – Research from Teva Pharmaceuticals shows that Europe’s critical medicine cabinets – in hospitals, pharmacies, and homes – are home to fewer generic medicines. These are the often-cheaper alternatives to brand name medicines, that make up 67%[1] of all medicines. Over the last ten years, the number of generic medicines withdrawn from the market increased by 12%, while on average 3% fewer generics products were launched. In other words, on 31 December 2012, there were 40 280 separate generic products and 10 y…

There are various techniques for the preparation of microspheres, and the selection of an appropriate method depends on the physicochemical properties of the drug. Currently, the most widely used methods include emulsion evaporation, phase separation, spray drying, and hot-melt extrusion, each with corresponding products on the market.
Emulsion Evaporation Method The solvent evaporation method is the most widely applied technique for microsphere preparation. In industrial production, it can be carried out using a reaction vessel or a static mixer, each with its advantages and disadvantages. Preparation Techniques in a Reaction Vessel For lipophilic drugs, the water-in-oil (O/W) emulsion method is employed. This involves dissolving lipophilic raw materials in an organic solvent as the oil ph…

In order to more effectively deliver chemotherapy drugs, Small Molecule Drug Conjugates (SMDC), Antibody Drug Conjugates (ADC), and Degradation Antibody Conjugates (DAC) have been successively explored and developed, enhancing the therapeutic index while providing selective delivery. What are their similarities and differences? What are their respective advantages? What is the current status of research and development? What are the prospects? This article analyzes each aspect.
Definitions SMDC consists of a small molecule drug (usually a highly active chemotherapy drug) and a targeting ligand (usually a small molecule), connected through conjugation technology. This conjugate can selectively deliver the drug to disease-related cells, such as cancer cells, thereby increasing efficacy and re…