Research and development - Articles
This article provides a comprehensive overview of medical device validation and verification while integrating supplementary services, ensuring a holistic approach to device development and compliance.
Introduction In the rapidly evolving healthcare landscape, medical devices play a pivotal role in enhancing patient care and improving health outcomes. The road to getting these devices from concept to patient use is filled with meticulous checks to ensure safety, efficacy, and compliance with regulatory standards. Central to this journey is the process of validation and verification (V&V), which helps in affirming that the medical device meets its intended requirements and functions safely within the medical environment. Design Validation and Verification The initial phase of medical dev…
Introduction In the rapidly evolving healthcare landscape, medical devices play a pivotal role in enhancing patient care and improving health outcomes. The road to getting these devices from concept to patient use is filled with meticulous checks to ensure safety, efficacy, and compliance with regulatory standards. Central to this journey is the process of validation and verification (V&V), which helps in affirming that the medical device meets its intended requirements and functions safely within the medical environment. Design Validation and Verification The initial phase of medical dev…
The FDA review process for De Novo requests includes a thorough risk assessment of the medical device to determine its safety and effectiveness.
De Novo is an approach for the FDA to classify novel medical devices based on risk for devices whose safety and effectiveness can be ensured through general controls or specific controls (i.e., low and moderate risk). De Novo provides both a pathway to bring innovative devices to market and establishes a new classification standard that will inform the marketing of similar devices in the future. In this article, we will provide an overview of the De Novo request and the application process. What Is De Novo? De Novo is a way used by the FDA to regulate the marketing authorization of certain novel medical devices. These medical devices cannot demonst…
De Novo is an approach for the FDA to classify novel medical devices based on risk for devices whose safety and effectiveness can be ensured through general controls or specific controls (i.e., low and moderate risk). De Novo provides both a pathway to bring innovative devices to market and establishes a new classification standard that will inform the marketing of similar devices in the future. In this article, we will provide an overview of the De Novo request and the application process. What Is De Novo? De Novo is a way used by the FDA to regulate the marketing authorization of certain novel medical devices. These medical devices cannot demonst…
PLGA has been extensively employed as a carrier for drug delivery systems, facilitating the transport of therapeutic agents including proteins, peptides, DNA, and diverse anticancer drugs.
Introduction to PLGA as Microsphere Material Poly (lactic-co-glycolic acid) or PLGA is a co-polymer synthesized from lactic acid and glycolic acid, widely recognized for its exceptional biocompatibility and biodegradability. Owing to these desirable properties, PLGA has been extensively employed as a carrier for drug delivery systems, facilitating the transport of therapeutic agents including proteins, peptides, DNA, and diverse anticancer drugs. The flexibility in its application can be attributed to its modifiable properties. By manipulating the monomer ratio, molecular weight, concentration, and termin…
Introduction to PLGA as Microsphere Material Poly (lactic-co-glycolic acid) or PLGA is a co-polymer synthesized from lactic acid and glycolic acid, widely recognized for its exceptional biocompatibility and biodegradability. Owing to these desirable properties, PLGA has been extensively employed as a carrier for drug delivery systems, facilitating the transport of therapeutic agents including proteins, peptides, DNA, and diverse anticancer drugs. The flexibility in its application can be attributed to its modifiable properties. By manipulating the monomer ratio, molecular weight, concentration, and termin…
The increased development of biopharmaceuticals makes a growing demand for the sensitive and reliable quantification determination of proteins in complex biological matrices such as plasma and serum.
The increased development of biopharmaceuticals makes a growing demand for the sensitive and reliable quantification determination of proteins in complex biological matrices such as plasma and serum. The method for quantifying proteins in biological matrices is based on ligand binding assays (LBAs) before. Currently, liquid chromatography coupled to tandem mass spectrometry (LC–MS/MS) has been demonstrated that can be used for the quantification of proteins. One of the main strengths of the technique lies in the possibility to use internal standards that correct for different sources of analyti…
The increased development of biopharmaceuticals makes a growing demand for the sensitive and reliable quantification determination of proteins in complex biological matrices such as plasma and serum. The method for quantifying proteins in biological matrices is based on ligand binding assays (LBAs) before. Currently, liquid chromatography coupled to tandem mass spectrometry (LC–MS/MS) has been demonstrated that can be used for the quantification of proteins. One of the main strengths of the technique lies in the possibility to use internal standards that correct for different sources of analyti…
Neuro-symbolic AI is a type of AI in which the algorithms mimic the structure and function of neural networks in human brains and recognize symbols associated with representations or relationships. In the pharmaceutical industry, neuro-symbolic AI can be especially helpful by enabling more effective drug repositioning, identifying appropriate patient cohorts more efficiently, and furthering personalized medicine.
Artificial intelligence has transformed many industries and processes, and some decision-makers are exploring how to apply AI to meet specific needs. They are also interested in how different types of AI could help them. Some business leaders have begun relying on neuro-symbolic AI. Its algorithms mimic the structure and function of neural networks in human brains and recognize sym…
Artificial intelligence has transformed many industries and processes, and some decision-makers are exploring how to apply AI to meet specific needs. They are also interested in how different types of AI could help them. Some business leaders have begun relying on neuro-symbolic AI. Its algorithms mimic the structure and function of neural networks in human brains and recognize sym…
13-Jan-2025
Healthcare providers operate in a high-stakes environment where protecting sensitive patient data is critical. With increasing cybersecurity threats and complex compliance requirements, maintaining secure and reliable systems is a priority.
Healthcare providers operate in a high-stakes environment where protecting sensitive patient data is critical. With increasing cybersecurity threats and complex compliance requirements, maintaining secure and reliable systems is a priority. A SOC 2 audit helps healthcare organizations meet these challenges head-on by providing a structured framework for managing data security, privacy, and operational integrity. Here’s why SOC 2 audits are essential for healthcare providers and how they can strengthen security practices while supporting complia…
Healthcare providers operate in a high-stakes environment where protecting sensitive patient data is critical. With increasing cybersecurity threats and complex compliance requirements, maintaining secure and reliable systems is a priority. A SOC 2 audit helps healthcare organizations meet these challenges head-on by providing a structured framework for managing data security, privacy, and operational integrity. Here’s why SOC 2 audits are essential for healthcare providers and how they can strengthen security practices while supporting complia…
The imaging technologies for precision agriculture market is expected to increase at a compound annual growth rate (CAGR) of 11.7% between 2025 and 2035. If the market continues on its current average growth trajectory, revenues are expected to reach USD 4.12 billion by 2035. By 2025, it is anticipated that the global market for imaging technology for precision agriculture will be valued at USD 1.29 billion.
The agriculture industry is undergoing a significant transformation driven by technological innovations. Among these, imaging technologies for precision agriculture stand out as game-changers, enabling farmers to enhance productivity, minimize costs, and adopt sustainable farming practices. The market for imaging technologies in precision agriculture is experiencing rapid growth, driv…
The agriculture industry is undergoing a significant transformation driven by technological innovations. Among these, imaging technologies for precision agriculture stand out as game-changers, enabling farmers to enhance productivity, minimize costs, and adopt sustainable farming practices. The market for imaging technologies in precision agriculture is experiencing rapid growth, driv…
From 2024 to 2034, the global market for circulating fluidized bed boilers is anticipated to develop at a compound annual growth rate (CAGR) of 3.7%. In 2034, the market is anticipated to reach USD 1,463.74 million based on an average development pattern. In 2024, the global market for circulating fluidized bed boilers is expected to generate USD 984.62 million in revenue.
The Global Circulating Fluidized Bed Boilers Market is expected to increase at a compound annual growth rate (CAGR) of 3.7% between 2024 and 2034. Based on an average growth pattern, the market is expected to reach USD 1,463.74 million in 2034. Revenue from the worldwide market for circulating fluidized bed boilers is projected to reach USD 984.62 million in 2024. Circulating Fluidized Bed (CFB) boilers are advanc…
The Global Circulating Fluidized Bed Boilers Market is expected to increase at a compound annual growth rate (CAGR) of 3.7% between 2024 and 2034. Based on an average growth pattern, the market is expected to reach USD 1,463.74 million in 2034. Revenue from the worldwide market for circulating fluidized bed boilers is projected to reach USD 984.62 million in 2024. Circulating Fluidized Bed (CFB) boilers are advanc…
Aurora Pro Scientific is a leader in advanced syringe and piston pump technologies, offering innovative solutions for precise and efficient fluid handling in laboratory and industrial applications. Our product lineup includes:
(1) Programmable Syringe Pumps with touchscreen controls and customizable infusion/withdrawal modes.
(2) Compact OEM Syringe Pumps for seamless integration into specialized analytical systems.
(3) High-Volume Piston Pumps with solenoid valves for automated high-throughput processes.
(4) Fixed-Volume Syringe Pumps with integrated glass syringes for consistent, repeatable dosing.
(5) Stirring Syringe Pumps for applications requiring simultaneous mixing and liquid handling.
(6) Multi-Channel Syringe Pumps for synchronized, parallel fluid handling in complex workflows.
02-Jan-2025
Materials testing is an essential part of research and development in industries such as manufacturing, aerospace, automotive and biomedical engineering.
Materials testing refers to techniques used to study the physical and chemical properties of materials. Materials such as metals, polymers, ceramics, composites and even biological tissues are included. Materials testing is an essential part of research and development in industries such as manufacturing, aerospace, automotive and biomedical engineering. Why Material Testing is Important? Ensure materials meet standards and requirements Firstly, it can help materials meet specific regulatory standards and requirements. For instance, materials used in biomedical devices must be biocompatible and safe in the body. Determine mechanica…
Materials testing refers to techniques used to study the physical and chemical properties of materials. Materials such as metals, polymers, ceramics, composites and even biological tissues are included. Materials testing is an essential part of research and development in industries such as manufacturing, aerospace, automotive and biomedical engineering. Why Material Testing is Important? Ensure materials meet standards and requirements Firstly, it can help materials meet specific regulatory standards and requirements. For instance, materials used in biomedical devices must be biocompatible and safe in the body. Determine mechanica…
Fluoropolymers are a group of specialized polymers characterized by carbon-fluorine bonds, known for their excellent chemical resistance and thermal stability.
What are Fluoropolymers? Fluoropolymers are a group of specialized polymers characterized by carbon-fluorine bonds, known for their excellent chemical resistance and thermal stability. These unique macromolecules are celebrated for their ability to withstand harsh environments that would typically degrade other polymers. They are critical in various industries such as aerospace, automotive, and chemical processing, where a longer lifespan and robustness to extreme conditions are essential. Fluoropolymers are divided into two main categories: fluoroplastics, known for their high resistance to heat and chemicals, and fluoroelastom…
What are Fluoropolymers? Fluoropolymers are a group of specialized polymers characterized by carbon-fluorine bonds, known for their excellent chemical resistance and thermal stability. These unique macromolecules are celebrated for their ability to withstand harsh environments that would typically degrade other polymers. They are critical in various industries such as aerospace, automotive, and chemical processing, where a longer lifespan and robustness to extreme conditions are essential. Fluoropolymers are divided into two main categories: fluoroplastics, known for their high resistance to heat and chemicals, and fluoroelastom…
Active pharmaceutical ingredients (APIs) are biologically active components in pharmaceutical drugs, responsible for the intended therapeutic effects.
Active pharmaceutical ingredients (APIs) are biologically active components in pharmaceutical drugs, responsible for the intended therapeutic effects. APIs are prepared through chemical synthesis or biotechnology, meeting stringent quality standards and regulatory requirements. We maintain a professional attitude and ensures the effectiveness and safety of our APIs product. APIs combine with excipients to create different dosage forms. In general, APIs play a pivotal role in drug therapy, benefiting patients worldwide through enhanced therapeutic efficacy and improved treatments. Anesthetic Analgesia APIs Anesthetics are a class of strong ana…
Active pharmaceutical ingredients (APIs) are biologically active components in pharmaceutical drugs, responsible for the intended therapeutic effects. APIs are prepared through chemical synthesis or biotechnology, meeting stringent quality standards and regulatory requirements. We maintain a professional attitude and ensures the effectiveness and safety of our APIs product. APIs combine with excipients to create different dosage forms. In general, APIs play a pivotal role in drug therapy, benefiting patients worldwide through enhanced therapeutic efficacy and improved treatments. Anesthetic Analgesia APIs Anesthetics are a class of strong ana…
Water for Injection is an essential component of pharmaceutical manufacturing, ensuring the safety and efficacy of products. From injectable drugs to vaccine production, WFI plays a critical role at every stage of the process, underscoring the need for precision, compliance, and innovation in its production and application.
Swjal Process is a leading pharmaceutical-grade water generation and distribution plant manufacturer in India.
The Role of Water for Injection (WFI) in Pharmaceutical Manufacturing Water for Injection (WFI) serves as a cornerstone of pharmaceutical manufacturing, where the highest standards of quality and purity are paramount. Its use spans the production of injectable drugs, vaccines, and other critical healthcare products, requiring utmost precision and control to e…
The Role of Water for Injection (WFI) in Pharmaceutical Manufacturing Water for Injection (WFI) serves as a cornerstone of pharmaceutical manufacturing, where the highest standards of quality and purity are paramount. Its use spans the production of injectable drugs, vaccines, and other critical healthcare products, requiring utmost precision and control to e…
Currently, there are more than 160 PROTAC projects under development worldwide, of which nearly 20 projects are in clinical development. These projects involve a variety of disease targets, including cancer, inflammation, and neurodegenerative diseases.
What Is PROTAC Technology? Proteolytic targeting chimera (PROTAC) is a new type of drug design technology that works by inducing the degradation of target proteins. Unlike conventional small molecules that typically inhibit protein function, PROTACs facilitate the ubiquitination and subsequent degradation of specific proteins. This bifunctional molecule consists of two distinct elements: a ligand that engages a target protein of interest and a second ligand that recruits the E3 ubiquitin ligase, a component of the ubiquitin-proteasome system…
What Is PROTAC Technology? Proteolytic targeting chimera (PROTAC) is a new type of drug design technology that works by inducing the degradation of target proteins. Unlike conventional small molecules that typically inhibit protein function, PROTACs facilitate the ubiquitination and subsequent degradation of specific proteins. This bifunctional molecule consists of two distinct elements: a ligand that engages a target protein of interest and a second ligand that recruits the E3 ubiquitin ligase, a component of the ubiquitin-proteasome system…
16-Dec-2024
Bladder cancer affects the body’s ability to urinate and can inflict pain. Healthcare professionals understand what causes this disease, though researchers are finding new causes. What are the latest findings on bladder cancer risk factors? Recent studies have discussed emerging causes and the continued importance of established reasons.
Bladder cancer affects the body’s ability to urinate and can inflict pain. Healthcare professionals understand what causes this disease, though researchers are finding new causes. What are the latest findings on bladder cancer risk factors? Recent studies have discussed emerging causes and the continued importance of established reasons. The Latest Developments in Bladder Cancer Risk Factors Discovering new causes of cancer helps medical professionals diag…
Bladder cancer affects the body’s ability to urinate and can inflict pain. Healthcare professionals understand what causes this disease, though researchers are finding new causes. What are the latest findings on bladder cancer risk factors? Recent studies have discussed emerging causes and the continued importance of established reasons. The Latest Developments in Bladder Cancer Risk Factors Discovering new causes of cancer helps medical professionals diag…
For life science startups, the road to innovation often begins with accurate and reliable diagnostic tools. Whether it’s identifying diseases or contributing to groundbreaking research, diagnostic testing for life science startups is an essential component of their success.
For life science startups, the road to innovation often begins with accurate and reliable diagnostic tools. Whether it’s identifying diseases or contributing to groundbreaking research, diagnostic testing for life science startups is an essential component of their success. Types of Diagnostic Testing When it comes to diagnostic testing for life sciences startups, understanding the various types is essential to developing innovative solutions. These are some of the most common categories and their applications. Molecul…
For life science startups, the road to innovation often begins with accurate and reliable diagnostic tools. Whether it’s identifying diseases or contributing to groundbreaking research, diagnostic testing for life science startups is an essential component of their success. Types of Diagnostic Testing When it comes to diagnostic testing for life sciences startups, understanding the various types is essential to developing innovative solutions. These are some of the most common categories and their applications. Molecul…
Hemorrhagic fevers (HF) are some of the most dangerous and complex diseases in the world, posing significant challenges to researchers and healthcare systems. They often progress rapidly and have the potential for devastating outbreaks. With traditional methods struggling to keep up, artificial intelligence (AI) has emerged as a game-changing tool in the fight against HF.
Hemorrhagic fevers (HF) are some of the most dangerous and complex diseases in the world, posing significant challenges to researchers and healthcare systems. They often progress rapidly and have the potential for devastating outbreaks. With traditional methods struggling to keep up, artificial intelligence (AI) has emerged as a game-changing tool in the fight against HF. How researchers are using AI to study hemorrhagic f…
Hemorrhagic fevers (HF) are some of the most dangerous and complex diseases in the world, posing significant challenges to researchers and healthcare systems. They often progress rapidly and have the potential for devastating outbreaks. With traditional methods struggling to keep up, artificial intelligence (AI) has emerged as a game-changing tool in the fight against HF. How researchers are using AI to study hemorrhagic f…
Cancer research is integral to advancing treatment options and developing cures for these diseases. With funding, resources, and collaboration, experts can improve their analysis and help patients. How are ECOG-ACRIN and Caris Life Sciences teaming up to fight cancer? Their recent announcement will benefit clinical trials and molecular profiling.
Cancer research is integral to advancing treatment options and developing cures for these diseases. With funding, resources, and collaboration, experts can improve their analysis and help patients. How are ECOG-ACRIN and Caris Life Sciences teaming up to fight cancer? Their recent announcement will benefit clinical trials and molecular profiling. How ECOG-ACRIN and Caris Life Sciences Are Teaming Up In October 2024, the ECOG-ACRIN Cancer Research G…
Cancer research is integral to advancing treatment options and developing cures for these diseases. With funding, resources, and collaboration, experts can improve their analysis and help patients. How are ECOG-ACRIN and Caris Life Sciences teaming up to fight cancer? Their recent announcement will benefit clinical trials and molecular profiling. How ECOG-ACRIN and Caris Life Sciences Are Teaming Up In October 2024, the ECOG-ACRIN Cancer Research G…
Pascal Degen, Vice President of Global Supply Chain Management at Bachem, explains the challenges faced by the CDMOs in a VUCA world
Pharmaceutical supply chains are becoming increasingly vulnerable to a range of disruptions. From geopolitical upheavals to natural disasters, the unpredictability of the modern world demands innovative strategies for maintaining stability in the face of disruption. Contract Development and Manufacturing Organizations (CDMOs) play a critical role in navigating these challenges by ensuring the consistent production and delivery of life-saving medications. There is a pressing need for CDMOs to address these supply chain challenges in a volatile, uncertain, complex, and ambiguous (VUCA) environment, and to implement strategies for resilience in the face o…
Pharmaceutical supply chains are becoming increasingly vulnerable to a range of disruptions. From geopolitical upheavals to natural disasters, the unpredictability of the modern world demands innovative strategies for maintaining stability in the face of disruption. Contract Development and Manufacturing Organizations (CDMOs) play a critical role in navigating these challenges by ensuring the consistent production and delivery of life-saving medications. There is a pressing need for CDMOs to address these supply chain challenges in a volatile, uncertain, complex, and ambiguous (VUCA) environment, and to implement strategies for resilience in the face o…
29-Nov-2024
Scientific breakthroughs are the catalyst to developing new treatments for diseases. From the rapid development of COVID-19 vaccines to a single-dose breast cancer treatment, novel science has been central. After releasing its novelty scores feature, DeSci Labs has enabled the public to compare the novelty scores of more than 250 million articles in the scientific literature. Here, Philipp Koellinger, co-founder and CEO, explains what the novelty scores are, and the effect they can have on the pharmaceutical sector.
Scientific breakthroughs are the catalyst to developing new treatments for diseases. From the rapid development of COVID-19 vaccines to a single-dose breast cancer treatment, novel science has been central. After releasing its novelty scores feature, DeSci Labs has enabled the p…
Scientific breakthroughs are the catalyst to developing new treatments for diseases. From the rapid development of COVID-19 vaccines to a single-dose breast cancer treatment, novel science has been central. After releasing its novelty scores feature, DeSci Labs has enabled the p…
