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Clinical Laboratory Improvement Amendments, more commonly known as CLIA, are federal regulations (in the US) that apply to any clinical laboratory that performs testing on humans, with the exception of clinical trials and basic research. A clinical laboratory...
The US Food and Drug Administration defines biologics as "a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins...composed of sugars, proteins, or nucleic acids...
The field of toxicology is a branch of science that "helps us understand the harmful effects that chemicals, substances, or situations, can have on people, animals, and the environment." The field of toxicology has evolved from focusing on chemicals and poisons to...
Anthrax Bacteria is a gram-positive, rod-shaped bacteria known as Bacillus anthracis. It causes a serious infectious disease in humans that come in contact with infected animals or contaminated animal products. To prevent the spread, Infectious Disease Laboratories...
Imperative to the drug and product development process, toxicity testing exposes the toxic effects of products on living organisms. A substance's toxicity can be observed through in-vivo and in-vitro tests which establish safe exposure levels. Toxicity testing is...
Residual DNA testing, or host cell DNA analysis, is the examination of products for traces of DNA that have been unintentionally left on a product during the manufacturing of biological products such as biosimilars or immunotherapeutic products. For customer health...
Pharmacogenetics is a branch of science that studies how a person's genetics influence their response to pharmaceuticals (read an entry to pharmacogenetics, here). Adverse Drug Reactions (ADRs) are one of the biggest influences in the study of pharmacogenetics, as...
Medical Device Sterilization Validation is imperative for invasive sterile medical products such as implants and reusable surgical instruments. ContractLaboratory.com routinely helps manufacturers, distributors, and healthcare facilities with their sterilization...
Need a laboratory for cancer research? Today, the US National Science Foundation issued a Press Release that the New York University Tandon School of Engineering has created a new synthetic hybrid molecule that delivers a blow to breast cancer cells. The hybrid...
What is Flow Cytometry? Flow cytometry is a technique employed to analyze cells in a solution allowing researchers to obtain very specific information regarding the chemical and physical characteristics of cells, such as their size, count, cycle, etc. The solution...
Best and easiest methods to distinguish diseases and tumor types Immunohistochemistry (IHC) is a technique used to diagnose, or even differentiate, different types of cancers or other diseases. This lab test uses fluorescently dyed antibodies to selectively test...
Biological purity and potency assays are procedures used by laboratories studying medicine, pharmacology, or other biological process, to assess or measure the presence of a substance, referred to as an analyte, whether it be a drug, a cell, or another organism....
Proteomics is a part of molecular biology that studies proteins. A proteome is a set of proteins that are either produced or modified by an organism and proteomics helps us understand things like the structure and function of the protein in an organism. The first...
How PFGE and WGS are used to detect illness outbreaks? DNA fingerprinting is often performed on bacteria isolated from people who are sick by using techniques called pulsed-field gel electrophoresis (PFGE) and whole-genome sequencing (WGS). These techniques provide...
Looking for liposome research? According to the US Food and Drug Administration (USFDA) Guidance Document entitled "Liposome Drug Products", a liposome is a microvesicle composed of a bilayer of lipid amphipathic molecules enclosing an aqueous compartment. It...
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