Biological potency assays. Medical search. Frequent questions

Positive hits in this screen were tested for specificity and potency in luciferase dose-response assays, and biological activity was tested in ex vivo Mullerian duct regression bioassays. (nih.gov)
Rapid and sensitive biomarkers and bioassays, both in vitro (e.g. protein binding assays, enzyme induction assays) and in vivo (e.g. zebrafish embryo assay) methods to measure the exposure, bioavailability, and effects of chemicals with endocrine disrupting potency are available. (vu.nl)
Reliable potency assays are arguably the most important cell-based bioassays, as these assessments are needed to characterize the ability of a drug to drive biologic activity in accordance with the intended therapeutic function, per ICH Q6B for biological drug substances and products. (element.com)
Bioassays are used to demonstrate that a biological product performs per the stated function and potency. (onlinecomplianceexperts.com)

Not only are reliable and accurate methods for determining drug potential and efficacy early in development essential, but cell-based bioassay development and biological assay validation must be accomplished quickly, given the highly competitive biologic industry, particularly for cell and gene therapy modalities. (element.com)
Many biologic drug developers rely on CDMOs to meet bioassay demands, and a reliable and credible contract partner for your cell-based assay can be the difference between struggle and success. (element.com)
Our scientists are adept at rapidly executing stage-appropriate, custom cell-based bioassay development and validation, in addition to other more routine cellular assays to assess biologic drugs robustly and accurately, regardless of modality, mechanism of action and target. (element.com)
Accelerate your program by leveraging our history of success and accumulated knowledge with our "off-the-shelf" bioassay solutions for various applications, also known as "platform methods," saving precious time by eliminating the need to seek out and develop assays for specific purposes from scratch. (element.com)
The cAMP Hunter™ CHO-K1 LHCGR Bioassay Kit an easy-to-use cell based assay to measure drug potency and detect neutralizing antibodies. (discoverx.com)
Bioassay kits are a convenient, ready-to-use format which contains all materials needed to run the assay, including single-use vials of cryopreserved cells, cell plating media, control agonist, detection reagent, and assay plates. (discoverx.com)
What is a bioassay or biological assay? (pharmacologycorner.com)
The biological indicators in bioassay are the reactions of living organisms or tissues. (pharmacologycorner.com)
The Bioassay team aims to develop and validate CMC biological potency assays from phase I readiness to phase III and beyond. (casss.org)
These values have structural relationships to substances with known biological activities, not values based on empirical bioassay. (cdc.gov)

Typically, site-directed and random mutagenesis are used to elucidate biological processes, determine protein structure, and develop screening assays, research reagents, and protein drugs. (codondevices.com)

Two original products, Eprex (epoetin alfa) and Dynepo (epoetin delta), and two biosimilar products, Binocrit (epoetin alfa) and Retacrit (epoetin zeta), were compared using (1) high performance size exclusion chromatography, (2) ELISA, (3) SDS-PAGE, (4) capillary zone electrophoresis and (5) in-vivo potency. (springer.com)
Selected candidates were further evaluated in ex vivo follicle/ovary culture assays and in vivo in mice and rats. (nih.gov)
This can be achieved from a consideration of physicochemical properties and data obtained from in vitro assays with human-derived material and in vivo animal studies. (europeanpharmaceuticalreview.com)

CGT products present specific challenges for developing in vitro potency assays due to their complex mechanisms of action, complicated manufacturing processes, variable critical quality attributes (CQAs) and reduced preclinical and early stage clinical data with which to inform development. (absorption.com)
Developing in vitro potency assays for CGT products must include at least two steps: demonstration of the vector's ability to transfer genetic material into a cell and demonstration of function. (absorption.com)
The development of an in vitro potency assay to accompany an approved CGT product involves a series of activities that can be divided into four key stages. (absorption.com)
Element's complete suite of CMC testing services include in vitro potency testing, in vitro cellular uptake, MTS assays, permeability studies and large molecule characterization, as well as IND/BLA submission support and regulatory consulting. (element.com)

A mechanistically relevant cytotoxicity assay based on the detection of cellular green fluorescent protein. (scienceblog.com)
The ethanolic extracts of the plant were examined for the presence of bioactive components and their total flavonoid content, with focusing on quercetin detection using thin layer bioautography (TLB) and brine shrimp lethality assay (BSLA) for cytotoxicity. (who.int)

From a regulatory perspective, an understanding of viral vector critical quality attributes that impact product safety, purity, and potency, mean that specific, robust analytical assays are needed. (intertek.com)
Approved biological products are required to be accompanied by analytical tests to demonstrate safety, purity and potency that are validated and performed under current Good Manufacturing Processes (cGMP) conditions. (absorption.com)

A ligand binding assay (LBA) is an assay, or an analytic procedure, which relies on the binding of ligand molecules to receptors, antibodies or other macromolecules. (wikipedia.org)
There are numerous types of ligand binding assays, both radioactive and non-radioactive. (wikipedia.org)
As such, ligand binding assays are a superset of radiobinding assays, which are the conceptual inverse of radioimmunoassays (RIA). (wikipedia.org)
Some newer types are called "mix-and-measure" assays because they do not require separation of bound from unbound ligand. (wikipedia.org)
Ligand binding assays are used primarily in pharmacology for various demands. (wikipedia.org)
Historically, ligand binding assay techniques were used extensively to quantify hormone or hormone receptor concentrations in plasma or in tissue. (wikipedia.org)
The ligand-binding assay methodology quantified the concentration of the hormone in the test material by comparing the effects of the test sample to the results of varying amounts of known protein (ligand). (wikipedia.org)
The foundations for which ligand binding assay have been built are a result of Karl Landsteiner, in 1945, and his work on immunization of animals through the production of antibodies for certain proteins. (wikipedia.org)
The first successful ligand binding assay was reported in 1960 by Rosalyn Sussman Yalow and Solomon Berson. (wikipedia.org)
As a direct result of these monumental findings, researchers have continued the advancement of ligand binding assays in many facets in the fields of biology, chemistry, and the like. (wikipedia.org)
Ligand binding assays provide a measure of the interactions that occur between two molecules, such as protein-bindings, as well as the degree of affinity (weak, strong, or no connection) for which the reactants bind together. (wikipedia.org)

Specifically, despite the human body's endogenous receptors, hormones, and other neurotransmitters, pharmacologists utilize assays in order to create drugs that are selective, or mimic, the endogenously found cellular components. (wikipedia.org)
From determining candidates and making initial investment decisions to lot release and stability testing, cellular assays are critical throughout biologic drug development. (element.com)
Leverage the experience and expertise of our team of skilled cell biologists to design cellular assays that carefully assess biologic activity to produce valuable data for product efficacy analysis, internal decision-making, and regulatory processes. (element.com)
If you need advanced characterization of biologic drug molecules, potency assay development, cellular response data, lot release support, or more, Element's cell culture expertise is at your disposal. (element.com)
In a PKN3 NanoBRET cellular target engagement assay established in our lab the inhibitory activity of literature compounds 1 - 6 , and synthesized molecules 10 , 11 , 15 , 16 , and 19a - f towards PKN3 was measured. (openlabnotebooks.org)

This lactone ring is a Michael acceptor that is known to affect biological processes such as cell proliferation, death/apoptosis, and cell migration, by interfering with nucleophilic sites in cell signalling pathways. (lu.se)

For the other two compounds, little usable data is available, and the magnitude of human risk associated with these compounds is based on biological activities and likely mechanisms of action. (cdc.gov)
The material from each step isscreened using acellular and in vitro assays for evaluating general toxicity, mechanisms of toxicity, and macrophage function. (cdc.gov)

Because a limited amount of EPO products was available, we were restricted to the common assays used for quality control: high performance size exclusion chromatography (HP-SEC) to assess monomer and aggregate content, ELISA to determine EPO protein content, SDS-PAGE under non-reducing conditions to detect possible fragmentation and covalent protein aggregates, capillary zone electrophoresis (CZE) for isoform profiling and a normocythemic mouse assay to test for potency. (springer.com)
Using a bone morphogenesis protein (BMP)-response element luciferase reporter cell-based assay, we screened 5,440 compounds from a repurposed drug library. (nih.gov)
In addition to adequate potency against the target protein and an acceptable safety profile, a balance of optimised PK parameters and minimised drug-drug interaction (DDI) potential maximises the chance of a candidate drug becoming a successful therapy. (europeanpharmaceuticalreview.com)
As detailed in an article posted online this week in Assay and Drug Development Technologies,* the new NIST assay uses a commercially available cell line genetically engineered to produce large amounts of green fluorescent protein (GFP). (scienceblog.com)
These opioid drugs produce their biological actions through three receptor types, μ, δ and κ, belonging to the family of seven transmembrane G protein-coupled receptors. (biomedcentral.com)
However, although Michael acceptors are reactive, the Michael addition is reversible and it can be assumed that also other parts of the molecules will moderate the binding to and the release from any given nucleophilic site in a protein, and thereby moderate a specific biological activity. (lu.se)

Analgesic potencies were evaluated after subcutaneous administration to mice using tail-flick and hot-plate tests. (biomedcentral.com)

The inherent complexity of viral vector-based products makes their physical and biological characterization highly challenging. (intertek.com)

FDA recommends a matrix approach - the examination of multiple assays or methods to explain the product potency. (redica.com)
In Pharmacopoeia, the two methods for performing microbial potency determinations are defined as the Diffusion (Cylindrical Plate) Method and the Turbidimetric Method. (hopetribune.com)
There are good arguments it has become apparent that in addition to hazard that the standard against which new methods are identification, the dose-response data available being judged is much higher than those in place from the LLNA also permit further characteriza- when existing assays were adopted. (cdc.gov)
This extension is the measurement of the scientific and regulatory community charged with relative skin sensitizing potency of a substance, the acceptance of new methods has to make prag- usually expressed as the estimated concentration matic decisions. (cdc.gov)

Release testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine. (biopharminternational.com)
Engineer therapeutic proteins to improve properties such as stability, potency, binding affinity, and immunogenicity. (codondevices.com)

In addition, contrary to the high affinity of compounds 4e , 8c and 10e for TNF in vitro , the potency of these compounds was determined to be low. (rsc.org)
The goal of the MLP is to screen compounds in the Small Molecule Repository in target-based and phenotypic assays to identify and subsequently optimize small molecule s as research probes. (nih.gov)
The IC50 values in the two cell lines were found to depend on the overall structure of the assayed compounds, although less in this subset of compounds compared to a previous investigation. (lu.se)

Potency is determined by means of a biological assay and interpreted by the first International Low Molecular Weight Heparin Standard as units of anti-factor Xa (anti-Xa) activity per milligram. (rxlist.com)

Quantitative activation suppression assay to evaluate human bone marrow-derived mesenchymal stromal cell potency. (ctsicn.org)
While many assays are qualitative, it is recommended to have at least one that is quantitative. (redica.com)

The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. (nih.gov)
Their relative activity in initiating cancer is likely to be roughly in proportion to their relative alkylation activity and mutagenic potency. (cdc.gov)
Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products. (xeominaesthetic.com)
Potency is a measure of a relevant biological activity as it relates to the clinical outcome and mechanism of action. (redica.com)
Microbial potency assays measure the biological activity or efficacy of antibiotics by growth repression on susceptible microorganisms at different concentrations. (hopetribune.com)
The structure-activity relationship observations, combining physicochemical and biological data, will be discussed. (biomedcentral.com)
Structure-activity relationships that may explain the observed differences in potency and selectivity are discussed. (lu.se)
SOR), hydrogen peroxide, and 2, 2-Diphenyl-2-picrylhydrazyl (DPPH) radical activity by a model (most biological y active) of the anticancer plant was also evaluated. (who.int)

In one run of the assay M molecules are tested, generating 2 M N data points. (physicsforums.com)
The assay is often repeated multiple times on certain molecules. (physicsforums.com)

STEMart introduced new Antibiotic Potency Tests to assess the bioactivity or potency of various antibiotics for medical devices. (hopetribune.com)
New York, USA - June 28, 2022 - STEMart, a provider of CRO services dedicated to integrated medical device and diagnostic clinical development, introduced new Antibiotic Potency Tests to assess the bioactivity or potency of various antibiotics for medical devices. (hopetribune.com)
More recently, information from LLNA dose-response analyses has been used to assess the relative potency of skin sensitizing chemicals. (cdc.gov)
The 'gold standard' method to assess humoral antibody responses fol owing vaccination is the neutralization assay. (who.int)

Toward this goal, we performed a comparative study on physicochemical properties and biological activities of well-known opioid morphinans such as the naturally occurring alkaloid morphine, and semisynthetic analogues e.g. oxymorphone. (biomedcentral.com)

and the flexibility to measure the potency of other ribosome inhibitors, even nanoparticles, with the same precision as ricin. (scienceblog.com)

Having a robust potency assay will be important when inevitable manufacturing changes occur. (redica.com)

The validation of potency assays for CGT products is difficult, as they are highly variable. (redica.com)
And in the BLA, the potency assay should be validated, and the validation report should be included. (redica.com)
Thorough validation of the assay based on pre-defined criteria included linearity, LOD/LOQ, accuracy, precision, selectivity and ruggedness. (shengsci.com)
It is concluded that the LLNA does provide a valuable assessment of relative sensitizing potency in the form of the estimated concentration of a chemical required to produce a threefold stimulation of draining lymph node cell proliferation compared with concurrent controls (EC3 value) and that all reasonable validation requirements have been addressed successfully. (cdc.gov)

Studies so far have shown that the spectral changes seen with solvatochromic dyes in the presence of potencies are the combination of a primary dye-potency interaction followed by subsequent dye p K a changes and dye aggregation processes. (thieme-connect.com)
6 ] By achieving this, the effect of potency on the dye intramolecular charge transfer process[ 7 ] can be examined in detail and any extraneous complicating processes removed. (thieme-connect.com)
Many technologies are used to characterize biological products, manufacturing processes, and raw materials. (bioprocessintl.com)

The current study aims to address these questions and provide the beginnings of an answer by separating out the initial dye-potency interaction free of any subsequent solute and solvent-mediated effects. (thieme-connect.com)

Essential aspects of binding assays include, but are not limited to, the concentration level of reactants or products (see radioactive section), maintaining the equilibrium constant of reactants throughout the assay, and the reliability and validity of linked reactions. (wikipedia.org)
To compare the quality of therapeutic erythropoietin (EPO) products, including two biosimilars, with respect to content, aggregation, isoform profile and potency. (springer.com)
Tested EPO products differed in content, isoform composition, and potency. (springer.com)
The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. (xeominaesthetic.com)
According to Article 2 of the WHO Constitution, WHO is required to "develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products. (who.int)
Meanwhile, all antibiotic products must be tested for potency before they are marketed. (hopetribune.com)
Both the EP and the USP require the use of microbiological assays on certain products. (hopetribune.com)

Consequently, the recommendation made here is that LLNA EC3 measurements should now be regarded as a validated method for the determination of the relative potency of skin sensitizing chemicals, a conclusion that has already been reached by a number of independent expert groups. (cdc.gov)

Our results show that small structural changes produce ligands with similar binding affinities ( K d ) for TNF , but significantly different potencies in a L929 cell-based assay . (rsc.org)
Cell-based assay Dev. (genscriptprobio.com)
Gwen Wise-Blackman , Ph.D. has over 20 years of combined experience in Cell-Based Assays and Quality Systems. (onlinecomplianceexperts.com)
Multidisciplinary bench scientist having worked in various roles and companies, from isolating rare and underrepresented cancers at the Broad Institute to automating cell-based toxicology assays in a CRO setting. (idbs.com)
Prior to joining IDBS, she worked at Allergan/AbbVie where she developed cell-based potency assays. (idbs.com)

In this commentary, the utility and validity of these relative potency measurements are reviewed. (cdc.gov)

Therefore, clinical data acquired from the original biological cannot necessarily be extended to its biosimilar(s). (springer.com)
The biological properties and clinical potential of stem cells elicit that are generated must not be unduly sensitive to small fluctu- continued scientific, commercial, and public interest. (lu.se)

The purpose of this approach is to de-couple the primary dye-potency interaction from any subsequent aggregation effects. (thieme-connect.com)

In addition, microbiological potency testing can also measure the effectiveness of the antibiotic directly on living microorganisms. (hopetribune.com)

the understanding of MSC biology, their mechanism of action (MoA) in different biological contexts, and their targeted and routine use in the clinics is limited ( Hoogduijn and Lombardo, 2019 ). (frontiersin.org)

Especially, the potency of originals may significantly differ from the value on the label. (springer.com)

4. the parameters that are returned are the so-called 'potency', which mathematically corresponds to the abscissa of the inflection point (KA in the Wiki article), the Hill slope (n) and the maximal %R (because Rmax is often defined based on a standard, independently from the individual molecule tested, so the asymptotic %R at the right plateau of the curve can often be different from 100%, greater or smaller). (physicsforums.com)
Can the 'standard deviation' or the assay itself be calculated from these data, as if they were direct, repeated measurements? (physicsforums.com)
The potency of one preparation (the "unknown") can be measured only in relationship to the potency of a second preparation (the "standard" or "reference drug") that elicits a similar biologic response. (pharmacologycorner.com)
When the absolute amounts of standard used in the assay are known, the results of the assay can be used to estimate the amount - in absolute units - of biologically active material contained in the unknown preparation. (pharmacologycorner.com)
Typically, the potency of an antibiotic product is determined by comparison with a standard or biological reference. (hopetribune.com)
Furthermore, tion of skin sensitization hazards that confers existing assays cannot necessarily be regarded as additional important benefits compared with the representing a `gold standard dataset' against standard guinea pigs tests, which it has tended to which novel tests are evaluated (1). (cdc.gov)
Recently, standard procedures were adopted for conducting neutralization assays. (who.int)

Assay cells exposed to the toxin will quickly stop synthesizing GFP. (scienceblog.com)
Biological weapons include any organism or toxin found in nature that can be used to incapacitate, kill, or otherwise impede an adversary. (medscape.com)

Through the development of RIA technology, researchers have been able to move beyond the use of radioactivity, and instead, use liquid- and solid-phase, competitive, and immunoradiometric assays. (wikipedia.org)
A major step toward this goal - the development of a rapid, reliable and precise assay of the potency of a ricin sample - has now been achieved by NIST scientists. (scienceblog.com)
The development of these new tests strictly follows the Antibiotics-Microbial Assays in USP General Chapter 81 to ensure the highest efficacy. (hopetribune.com)
If you have additional questions about Antibiotic Potency Tests for medical devices or if you would like to know more about STEMart's medical device development service, please visit https://www.ste-mart.com . (hopetribune.com)

the precision of the estimate should always be determined, using the data of the assay. (pharmacologycorner.com)
Early dose predictions provide a means of integrating biological and PK data and thus provide a holistic assessment of overall compound quality. (europeanpharmaceuticalreview.com)
It has been shown also, by several independent groups, that EC3 values correlate closely with data on relative human skin sensitization potency. (cdc.gov)

In vitro binding affinities and selectivities to opioid receptors were determined in rodent brain membranes using binding assays. (biomedcentral.com)

Conclusions The conditions used in this and previous studies to investigate the interaction of potencies with solvatochromic dyes preclude increased polarity of solvent as being responsible for the observed effects and that an explanation in which potencies carry an electric field (or electric field-like) component is by far the more likely. (thieme-connect.com)
3 ] To understand more about how potencies are acting, it is therefore important to de-couple the primary interaction from these latter consequential effects. (thieme-connect.com)
In other words, it is possible to study the initial dye-potency interaction in its pure form. (thieme-connect.com)
e) The nature, direction and magnitude of a biological interaction, if any, between substances in a mixture will remain uncertain until ATSDR develops an evaluation process based on experimental evidence. (cdc.gov)

This process has already been undertaken we have examined critically the relevance to several years ago for the local lymph node assay humans, the robustness and the reliability of (LLNA) (2). (cdc.gov)

Sandy's comment: Do you ever wonder why some scientists, having discovered an important biological fact that connects other things in biology that had hitherto not been connected to it, begin to try to explain everything in terms of that newly discovered connection. (life-enhancement.com)
Since then, this area of biology has rapidly expanded in clinics: The FDA approved an average of 15 new biological entities every year between 2006 and 2011 (2). (bioprocessintl.com)

Hi everyone, I have a question about the error on certain biological results. (physicsforums.com)
Results Despite large differences in molecular structure between dyes, results show that potencies affect all dyes according to the same fundamental principles. (thieme-connect.com)
These results illustrate the combined impact of genetic, lifestyle, and environmental factors in modulating immunological responsivity and emphasize the importance of the exposome in shaping biological responses. (cdc.gov)

Potency is a property of the material to be measured, e.g., the drug, not a property of the response. (pharmacologycorner.com)
Ordinarily, the relationship between changes in behavior of the indicator and differences in drug dose - (a dose-effect curve) - must be determined as a part of each assay. (pharmacologycorner.com)

An advanced toxicology laboratory is available for highly specialized toxicological work such as genomics, metabolomics and molecular biological studies (e.g. qPCR). (vu.nl)
Several studies have shown that homeopathic potencies interact with a large range of π-conjugated push-pull, or solvatochromic, molecular systems. (thieme-connect.com)

Compared with measuring the potency chemically, assessing antibiotic potency microbiologically can verify the ability of the antibiotic to destroy selected organisms and the concentrations at which the antibiotic can work effectively. (hopetribune.com)

The potency assay should be developed early on and qualified before the start of the phase three study. (redica.com)
If the potency assay is not qualified prior to the start of the phase three study, that can be a reason to place an IND on hold," Eacho cautioned. (redica.com)

Anatomy1

Chemicals and Drugs4

Analytical, Diagnostic and Therapeutic Techniques and Equipment4

Phenomena and Processes6

Information Science3

Bioassays4

Bioassay10

Develop screen1

Vivo3

Vitro potency4

Cytotoxicity2

Analytical2

Ligand11

Cellular5

Apoptosis1

Mechanisms2

Protein6

Subcutaneous1

Characterization1

Methods4

Stability2

Compounds3

Means of a biological1

Quantitative2

Activity8

Molecules2

Assess4

Physicochemical properties1

Inhibitors1

Robust1

Validation4

Processes3

Aims1

Products7

Determination1

Cell5

Validity1

Clinical2

Aggregation1

Measure1

Mechanism of act1

Significantly1

Standard7

Toxin2

Development4

Data3

Receptors1

Interaction4

Reliability1

Biology2

Results3

Drug2

Molecular2

Concentrations1

Study2