Research and development - Articles

In microbial ecology, metagenomic techniques are now widely utilized to research microbial communities in greater depth, including many strains that cannot be produced in the lab. Microbial bioinformatics may now be used to mine large metagenomic datasets for broad patterns that govern microbial communities. Typical metagenomic and bioinformatic investigations, on the other hand, do not fully characterize the ecology and evolution of microorganisms in their habitats. The majority of analyses still rely on basic sequence similarity searches against reference databases.
Introduction to Bioinformatics for Microbial Metagenomics In microbial ecology, metagenomic techniques are now widely utilized to research microbial communities in greater depth, including many strains that cannot be produced…

It is of great significance to study the stability of pharmaceutical preparations to ensure product quality, safety, and effectiveness.
The basic requirements of pharmaceutical preparations are safety, efficacy, and stability. Drug stability means that a drug product should maintain the same properties and characteristics as it was at the time of production and within the specified time frame. The stability of pharmaceutical preparations directly affects the effectiveness and safety of drugs. Therefore, it is of great significance to study the stability of pharmaceutical preparations to ensure product quality, safety, and effectiveness. Research Scope on Drug Stability Analysis Chemical stability refers to changes in drug content (or potency) due to chemical reactions such as hydrolysis and…

Enzyme engineering is an enzyme technology. With the rapid development of enzymology research, especially the promotion of enzyme application, the basic principle of enzymology is combined with chemical engineering, thus forming enzyme engineering. Enzyme engineering is a technology for the mass production and application of enzyme preparations. Starting from the purpose of application, it combines the theory of enzymology with chemical engineering to study enzymes, and uses the catalytic properties of enzymes in a certain reaction device to convert raw materials into products. As far as the development of enzyme engineering itself is concerned, it includes the following main aspects.
Enzyme engineering is an enzyme technology. With the rapid development of enzymology research, especially t…

Lactase is a disaccharidase present on the surface of mammalian small intestinal mucosal microvilli, and many beneficial intestinal bacteria have the ability to produce lactase. Lactase deficiency is present in most of the world's population, affecting nearly 2/3 of the world's population.
Lactase is a disaccharidase present on the surface of mammalian small intestinal mucosal microvilli, and many beneficial intestinal bacteria have the ability to produce lactase. Lactase deficiency is present in most of the world's population, affecting nearly 2/3 of the world's population.   Polylactose is composed of glucose and galactose, these two monosaccharides are easily absorbed by the intestinal lumen and are an important source of human tissue structure and energy. The precondition for lacto…

Excipients are designed to interact with and enhance the properties of APIs. Excipients have various functions.
Pharmaceutical excipients are substances formulated together with active pharmaceutical ingredients (APIs) of the drug, and excipients account for most of the drug composition. Excipients are designed to interact with and enhance the properties of APIs. Excipients have various functions. In addition to acting as carriers, and improving stability, pharmaceutical excipients are also conducive in terms of solubilization, sustained release, and controlled release. Overall, they are important components that may affect the quality, safety and effectiveness of drugs. Excipients can be classified by source, function, route of administration, and the like. By Source They can be divided in…

If a crisis is recognised, it can be a powerful accelerator of change. But do we always spot a crisis when we see it? Often there needs to be a key event (or series of events) to highlight the situation and signal that a turning point has been reached. Here are three crises—two that have been widely seen, and a third that needs more attention.
Crises can’t be dealt with until they are recognised By Robert Hewitt, MB BS, PhD, Biosample Hub If a crisis is recognised, it can be a powerful accelerator of change. But do we always spot a crisis when we see it? Often there needs to be a key event (or series of events) to highlight the situation and signal that a turning point has been reached. Here are three crises—two that have been widely seen, and a third that needs more attention. A Quality Cr…

Chymotrypsin is a typical serine protease. As an endopeptidase that catalyzes the hydrolysis of protein peptide bonds, its realization form is mainly for the cleavage of the peptide bond formed by the carboxyl end of the aromatic amino acid-tryptophan, phenylalanine or tyrosine. Chymotrypsin is a typical serine protease and is currently one of the digestive enzymes of most vertebral animals.
Chymotrypsin is a typical serine protease. As an endopeptidase that catalyzes the hydrolysis of protein peptide bonds, its realization form is mainly for the cleavage of the peptide bond formed by the carboxyl end of the aromatic amino acid-tryptophan, phenylalanine or tyrosine. Chymotrypsin is a typical serine protease and is currently one of the digestive enzymes of most vertebral animals.   Simi…

The United States Pharmacopeia (USP) requires that all new drugs and generic drugs, whether they are on the market or under review or to be declared, must meet the requirements of the General Principles for the Control of Elemental Impurities Limits (USP).
From January 1, 2018, the United States Pharmacopeia (USP) requires that all new drugs and generic drugs, whether they are on the market or under review or to be declared, must meet the requirements of the General Principles for the Control of Elemental Impurities Limits (USP<232>). To perform elemental impurity analysis, below are some necessary steps that should be considered. The first step: Determine which elements to be verified Before all verification work begins, the element impurities that need to be tested must first be cla…

Microbial limit test is performed to determine whether drug products comply with an established specification for microbial quality.
Microbial limit test is performed to determine whether drug products comply with an established specification for microbial quality. USP <61> and USP <62> for objectionable organisms are usually the guidelines for testing as specified by FDA requirements. In most cases, the microbial limit test covers the following three test items: Total Aerobic Microbial Count In this step, the total number of aerobic organisms is determined, which is an important indicator to measure the hygienic quality of medicines. Total Combined Yeasts and Mold Count In this step, the number of contaminated viable bacteria (yeasts and mold) in the unit mass, volume…

The quantitative analysis of a small amount of amorphous existence plays a vital role in the process of drug development and production.
In industrial production, the surface of the compound may become amorphous due to a small amount of structural damage. It is difficult for conventional instruments to detect this small amount of amorphous substance. Although the content of this amorphous substance is very low, it is very likely to affect the stability of the drug in the production and storage process, resulting in the failure of the entire development. Therefore, even the quantitative analysis of a small amount of amorphous existence plays a vital role in the process of drug development and production. Amorphous content determination and identification The qualitative and quantit…

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your clinical trials. This article explores the features that a clinical MDR software should have.
It’s tough trying to choose and implement new software and systems. And clinical metadata repositories (MDRs) are no exception. But, they’re a must these days. Everything’s moving towards efficiencies and automation. You don’t want to get left behind. So what should you expect as a given when it comes to a clinical metadata repository? Well if the clinical metadata repository you’re looking at doesn’t meet these basic specifications, find another one that does! Or you could be wasting your time – and potentially a lot of money too. Here’s…

Automation is used to improve the accuracy of results in the clinical trial process from study setup through to submission. It removes manual processes such as creating forms and annotations by hand or entering data manually onto a spreadsheet. Results are accurate as human error is reduced. Automation also makes it easier to comply with the standards required by regulatory authorities, such as the FDA.
Many companies in the life sciences industry are slow to adopt new technologies. This is down to greater costs, greater operational burden, and uncertainty with meeting the complex regulatory requirements put in place. However, there has been a lot of advancement in new and emerging technologies for automating clinical trials in recent years. The FDA has recognized their benefits a…

Microbial limit test is performed to determine whether drug products comply with an established specification for microbial quality.
Microbial limit test is performed to determine whether drug products comply with an established specification for microbial quality. USP <61> and USP <62> for objectionable organisms are usually the guidelines for testing as specified by FDA requirements. In most cases, the microbial limit test covers the following three test items: Total Aerobic Microbial Count In this step, the total number of aerobic organisms is determined, which is an important indicator to measure the hygienic quality of medicines. Total Combined Yeasts and Mold Count In this step, the number of contaminated viable bacteria (yeasts and mold) in the unit mass, volume…

There are non-functional excipients and functional excipients. The choice of excipients for oral solid preparations is affected by factors such as the pharmacological and chemical properties of the raw materials, the preparation process and the price of excipients.
Excipients are the general term for all materials in the prescription except the main active ingredients, such as binders, disintegrants, lubricants, fillers, etc. The choice of excipients for oral solid preparations is affected by factors such as the pharmacological and chemical properties of the raw materials, the preparation process and the price of excipients. There are non-functional excipients and functional excipients. Let’s take a look at the non-functional excipients that are commonly used in solid oral preparations. Dis…

No sooner than medical device manufacturers have completed their MDR compliance project, they must prepare to adapt products, labelling and artwork to comply with upcoming IVDR counterpart legislation. Bob Tilling, VP Global Sales at Kallik, reveals the top compliance challenges manufacturers must address and how digital solutions are now set to play a leading regulatory role.
The EU’s In Vitro Diagnostic Regulation is set to be implemented in May 2022, but for many in vitro medical device manufacturers, the follow-on UDI implementation deadlines – Class D in 2023, Class C and B in 2025, and Class A in 2027 – will have greater repercussions. Over 80% of devices not requiring certification under the previous IVDD (In Vitro Diagnostic Directive) will now require IVDR certification, affecting…

They may have been developed to better manage fluids on production lines, but transparent pressure vessels are increasingly being seen as ideal testing environments for research and development. With orders from blue chip companies including Apple research organisations like Boston Scientific and major universities, engineer Loris Medart from SR-TEK discusses how vessels designed for use in industry are revolutionising R&D.
Fluids have long been seen as one of the most difficult substances to manage on a production line. Movement, pressure, temperature, and humidity are just a few of the factors that can drastically alter fluid performance. As a result, when creating the world’s only commercially available transparent pressure vessel we had to ensure it enabled complete control of the inter…

Leukemia cell lines are important and widely used research tools. Their usefulness is mainly connected with their ability to provide an indefinite source of biological material for experimental purposes. Due to their high relevance for human disease, easy manipulation, and relative low costs, leukemia cell lines continue to represent vital in vitro model systems for a large range of ongoing investigations, especially basic leukemia research and drug discovery.
Leukemia cell lines are important and widely used research tools. Their usefulness is mainly connected with their ability to provide an indefinite source of biological material for experimental purposes. Due to their high relevance for human disease, easy manipulation, and relative low costs, leukemia cell lines continu…

Human primary cardiomyocyte-based models are superior to whether artificial cellular models or animal models due to their native physiological and pharmacological properties. Therefore, human primary cardiomyocytes have the potential to become the most clinically relevant model for developing novel cardiac drugs and predicting safety assessment of new drugs.
What are Human Cardiomyocytes? The heart is one of the first organs formed in the embryo, which highlights its crucial function in pumping blood to carry oxygen and nutrients to other tissues of the organism whether during development or in later life. Human primordial heart starts to beat at around 22 days after fertilization. It is the presence of cardiomyocytes that results in the early beating of the heart. Cardiomyocytes,…

Animal primary cells are isolated directly from healthy or diseased tissue via an enzymatic, chemical, or mechanical process. These cells can be taken from the animal’s kidney, liver, skin, or another organ. Once removed from the in vivo environment, these cells are then placed in an artificial (in vitro) environment for propagation.
Animal Primary Cells Animal primary cells are isolated directly from healthy or diseased tissue via an enzymatic, chemical, or mechanical process. These cells can be taken from the animal’s kidney, liver, skin, or another organ. Once removed from the in vivo environment, these cells are then placed in an artificial (in vitro) environment for propagation.   When in an in vitro environment, animal cells must be carefully cultured. This includes ensu…

Stem cells are primitive, undifferentiated cells that can potentially turn into a wide variety of cell types. Liver cells, blood cells, and muscle cells are only a few of the specialized types that have their origin in stem cells. Aside from their ability to differentiate into cells with specific functions, they can also divide or renew themselves indefinitely.
Stem cells are primitive, undifferentiated cells that can potentially turn into a wide variety of cell types. Liver cells, blood cells, and muscle cells are only a few of the specialized types that have their origin in stem cells. Aside from their ability to differentiate into cells with specific functions, they can also divide or renew themselves indefinitely.     Because they can repair and regenerate damaged tissue…