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Biological Safety Articles & Analysis
106 articles found
For decades, USP Class VI testing (USP 88) has been a recognized benchmark for assessing the biological safety of polymers and other materials used in medical and pharmaceutical applications. It has offered manufacturers a way to demonstrate compliance and reassure customers about the safety of their ...
In highly regulated industries such as pharmaceuticals, biotechnology, and advanced manufacturing, contamination control is non-negotiable. Airborne particle monitoring plays a central role in ensuring cleanroom environments meet strict regulatory requirements like EU GMP Annex 1: 2022 and ISO 14644. One of the most effective tools for achieving continuous, reliable oversight is remote ...
This testing is essential for ensuring the safety and purity of biological products. Here are several commonly used HCP coverage testing methods:1. ...
Various microbial, viral, and viroid pathogens of cannabis can result in economic loss in commercial cultivation settings. While starting off with uninfected stock material is a crucial first step in combating this, tool and surface sanitation practices in the grow facility are also very important to reduce the chance of spread of any undetected, or newly environmentally acquired pathogens. While ...
This may cause allergic reactions or reduce the efficacy of biopharmaceuticals.2. Safety IssuesSome HCPs may have unknown biological activity or toxicity. ...
By conjugating PEG chains to drug molecules, pharmaceutical companies can create formulations that dissolve more readily in biological fluids, ensuring that the active ingredient reaches its target site in the body. ...
Glycosylation identification of protein drugs is a crucial step in the fields of biotechnology and drug development. It concerns the safety, stability, and biological activity of protein drugs. In the following, we will delve into the importance, methods, and applications of protein drug glycosylation identification in drug development.Importance of Protein Drug ...
At present, genetic diseases are a large category of diseases that affect human health. So far, we can only treat a small part of them, and most of the treatment methods are "treating the symptoms but not the root cause". Therefore, gene therapy that can "cure the root cause" is highly anticipated. Gene therapy is a treatment method that uses modern molecular biology methods to repair ...
Microfluidic technology should not only comply with the general rules of scientific and technological development, but it should also achieve no cross-contamination and high biological safety. At present, there is still a certain gap between microfluidic flow methods and traditional flow methods in terms of flow rate, sorting flux, and number of sorting channels. ...
Compared with other carrier materials, PLGA nanocarriers have the following advantages: It is polymerized by glycolic acid and lactic acid, and the synthesis process is relatively mature; The nanoparticle size is controllable, uniform in size and small in dispersion; It can achieve long-term sustained release of carrier drugs (several weeks or months), reduce the frequency of medication, and ...
In laboratory settings, airflow management plays a vital role in ensuring the safety of personnel, maintaining equipment functionality, and obtaining accurate experimental results. ...
To optimize LNP and increase the yield to enhance the safety of mRNA vaccine, research teams from the New Jersey Institute of Technology and Shanghai Jiao Tong University designed an enzyme-catalyzed one-step method to synthesize ionizing cationic lipids. ...
IRTA has one of the largest and most modern biosafety building level 2 facility in Europe. With more than 500 m2 of surface area and 10 IRTAmar recirculation units where challenge and pathology assays are carried out, developing new vaccines. The plant is equipped with a double system of sterilization and disinfection of the reject water, which guarantees environmental safety. ...
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Why do manufacturers like ESCO, ThermoFisher Scientific, and Nuaire adopt different air speed values for 2A2 and 2B2 biological safety cabinets compared to the suggested range of 0.36 m/s to 0.54 m/s? ...
A biosafety cabinet (BSC) is a type of laboratory equipment that provides a controlled environment for handling potentially infectious biological materials. Biosafety cabinets are designed to protect the user, the environment, and the samples being handled from exposure to biological hazards.BSCs are classified into three categories based on the level of ...
Most biological agents enter the body directly without passing through the gastrointestinal tract, so in addition to biological activity, relevant authorities have very strict requirements on impurities in drugs. Among them, the host cells residual DNA has always been the focus of regulatory agencies because of its special potential safety risks. ...
The primary purpose of a fume hood is to provide protection to lab workers while working with toxic fumes, gases, and chemicals by filtering the air inside the laboratory. But how exactly do fume hoods achieve that? Do fume hoods have HEPA filters? Chemical Fume Hoods There are several different types of fume hoods and the type that will work best for your workspace will depend on several ...
Temperature monitoring during biomedical low-temperature transportation and storage is widely used in drugs, hospitals, pharmacies, CDCs, testing centers, and biopharmaceutical companies to ensure the safety and effectiveness of biological samples, drugs, blood products, vaccines, and testing reagents. ...
Viral vector manufacturing During process development/optimization, the FDA mandates that overall product characterization under cGMP (current Good Manufacturing Practice) follows SISPQ (Safety, Identity, Strength/Potency, Purity, and Quality). l Safety: The product does not elicit unexpected side effects when used appropriately in the patient. ...
While laminar flow hoods are similar to fume hoods and biological safety cabinets, it is extremely important to note that they have separate functions. Before making an investment, you’ll want to be aware of which piece of equipment will be the right choice for your lab. Fume Hoods and Biological Safety Cabinets The ...