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Immunogene therapy is a combination of two different treatment methods: gene therapy and immunotherapy. In immunogene therapy, a protein/antibody, gene, or nucleic acid molecule is
Immunogenicity assays are designed to determine the immune response to biotherapeutics such as protein, peptide, antibody, oligonucleotide or DNA/RNA-based drugs and its clinical impact. In
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected hundreds of millions of individuals worldwide, disrupting public health and the economy. Post-COVID (or Long-COVID), the
As new cases of COVID-19 soar, experts warn about the newly emerged COVID subvariant BA.5, a sub-lineage of BA.2. Subvariants of Omicron BA.1 emerged in
Why have Lot Release Potency Testing? The US FDA requires that manufactured drug lots pass critical analysis before release by the manufacturer for clinical use.
Why Do STABILITY Studies / Testing? Stability studies are performed to ensure that pharmaceutical products will be at the acceptable level of quality throughout the
Now that Christmas and many other celebrations gather people around a table, it is important to know about the risks we take and the science
Regeneron’s antibody cocktail for treatment of COVID-19 infection (REGEN-COV, comprised of monoclonals casirivimab and imdevimab) was approved by the FDA in October 2020 for mild-to-moderate
In a classic case of Darwinian selection, the successful Delta variant (B.1.617.2) has largely displaced all other forms of the coronavirus underlying the ongoing global
Recombinant Monoclonal Antibodies for Therapeutic Use Recombinant monoclonal antibodies are one of the most promising drugs (immunotherapy) for human diseases, including infectious diseases, cancer, and
Efficacy of mRNA vaccines on SARS-CoV-2 variants (UK and South Africa) Detection of mutations arising in the genome of the SARS-CoV-2 virus responsible for COVID-19
Potential Multiple Sclerosis mRNA Vaccine BioNTech in Germany is one of two companies (the other being Moderna in the US) that have successfully developed mRNA
Different types of vaccines work in different ways to offer protection, but with all types of vaccines, the body is left with a supply of
SARS-CoV-2 is more virulent than SARS-CoV (identified in 2003), because it binds to host cells with greater affinity, and more recently (see below) uses another
Some kits are suitable, but will they fit your purpose? Should you use a kit for an ELISA, cell based assay, and enzyme assay or even
Cytokines are a broad and loose category of small proteins (5-20 kDa molecular weight) important in cell signaling, particularly in the regulation of immune system
Innate Immunity and Adaptive Immunity Innate immunity is the initial immune response to infectious agents, carried out mainly by granulocytes and macrophages. These include a variety
T Cell and Innate Immune Responses to Viral Infection – Implications for the Pandemic While much of the focus on treating COVID-19 and preventing its
Vaccine development is protracted and risky. On average, vaccines take more than 10 years to move from the preclinical phase to approval, and the probability
The unprecedented scale of scientific effort being applied to countering the pandemic is already beginning to bear fruit. Current estimates of the infection fatality rate
There are two principal immunological test formats used to check for the presence of anti-SARS-CoV-2 antibodies in blood as evidence of a previous COVID-19 infection.
Two types of COVID-19 tests There are two types of tests being conducted in addressing the COVID-19 disease pandemic. The more commonly administered test is
HISTORY OF INITIATING THE FDA Early drug development in Europe rested with the people who tanned hides. They tasted their chemicals and sometimes treated malady’s
BACKGROUND: With the discovery of DNA polymerase in 1956, an enzyme that replicates DNA, a new world of science was opened. The next big discovery
The diagram above represents the infiltration from the blood vessels of the immune cells (see below) into the lung alveoli sack with a cytokine storm
ELISA is a quantitative and ultra-sensitive plate-based assay designed to detect and quantify substances such as antibodies, hormones, proteins (e.g. cytokines) and peptides, receptors on cells
Flow cytometry can differentiate different cell populations based on cell size by forward and side scatter measurements. Specific cell types are also be identified by
Often times we get questions about cell based assays (bioassays) that seemed like they should have performed better than they did. Since we perform bioassays
Cell death, overt death or inhibition of growth, occurs by several mechanisms, including necrosis and programmed cell death, most notably apoptosis. Necrosis is generally caused