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Eagle Biosciences is excited to highlight our product series for Host Cell Protein Detection!

Host cell proteins (HCPs) are a major class of impurities produced during biotherapeutic manufacturing. They must be removed from the final drug product to both assure patient safety and maintain drug efficacy. Our wide range of Host Cell Protein Detection Kits are easy to use and highly sensitive.


What are HCPs and why must they be removed from biologic drugs?

HCPs are proteins produced or encoded by the host organisms used to produce recombinant therapeutic proteins. Genetic engineering allows the host organism cells to be transformed to produce a protein of interest. During the recombinant protein production, host cells also coproduce proteins related to the normal cell functions such structural proteins, as well as proteins required for normal cellular growth and function, and vary in both number and concentration depending on the chosen host species and the manufacturing process being used. In general, apart from the therapeutic protein of interest, all endogenous proteins co-expressed by the host cells are called host-cell proteins.

Why must HCPs be removed from biologic drugs?

HCPs must be removed from the final biotherapeutic product to avoid adverse effects. Almost all HCPs carry safety risks as foreign proteins due to the potential to elicit immune response in humans (e.g, cytokine storm). In addition, some HCPs can also act to enhance the immune response to a drug product. Certain HCPs can also affect drug product stability and efficacy if not adequately removed or inactivated.

How are HCPs detected?

ELISAs are widely used for detecting HCPs, where they are generally configured in a sandwich assay format for improved specificity. In this scenario, a microplate-bound antibody is used for analyte capture, then a second analyte-specific antibody (that binds a different epitope on the target molecule) is added to enable detection. By incorporating a reference standard (e.g., a purified protein) into the assay design, it is possible to quantify the analyte of interest and confirm that its concentration meets regulatory requirements. Advantages of ELISA are that it is sensitive and compatible with high sample throughput – key considerations for biopharmaceutical manufacturing.


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The measurement of cell proliferation and cell toxicity is fundamental in biomedical research, especially in fields such as cancer biology, pharmacology, and toxicology. These parameters provide essential information about cell health, growth dynamics, and the effects of external agents such as drugs, environmental toxins, or genetic modifications.

Biomedica’s EZ4U ELISA Assay Kit (BI-5000) was highlighted in a recent study that investigated the development of novel chemosensitizers targeting therapy-resistant cancer stem cells (CSCs). The metabolic activity of cells was assessed using various cell lines. The study shows that telmisartan derivatives serve as effective chemosensitizers and offer an innovative approach for targeting CSCs in different types of malignant diseases. Click below for the full publication, where you can find the abstract and key findings!

Eradication of Therapy-Resistant Cancer Stem Cells by Novel Telmisartan Derivatives. Schoepf Anna M. et al., J Med Chem. 2025; 68(1):287-306


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The DHEA ELISA Assay Kit was highlighted in recent publication that explored how low psychological resilience and physical fitness predict attrition from US Marine Corps Officer Candidate School training! For more details, reference the abstract and access the full text below.


Abstract

The objective is to examine the predictors of attrition in male and female candidates undergoing a 10-week early career military training program. 1006 candidates (79.5% male, 24.7 ± 3.2 years) consented to participating in a larger study examining predictors of injury during US Marine Corps Officer Candidates School (OCS). Participants completed a blood draw, demographic and psychological characteristics questionnaires, and two fitness tests. Participants were then grouped based on successful completion of OCS or not. Associations between potential predictors and attrition were analyzed using simple logistic regression analyses, followed by a backward stepwise elimination method. Area under the curve (AUC) of the receiver operating characteristic (ROC) curve was used to determine the accuracy of the attrition prediction model. 260 candidates (25.8%) attritted over the 10-week training, with the highest number of discharges during week 5. Musculoskeletal injury (MSKI) was the most common cause of attrition (30%), followed by non-MSKI medical (21.5%), and volitional withdrawals (19.6%). Sex, body mass index (BMI), resilience, initial physical fitness test score, combat fitness test (CFT) score, and prior military service were all significantly associated with attrition from OCS (all p < .05). The final prediction model of attrition included CFT score (p = .027) and resilience (p = .018). Multiple demographic, psychological, and fitness characteristics are associated with attrition from an early career military training course (OCS) and may be utilized as part of early screening procedures to identify and provide guidance for individuals at risk for not completing OCS.


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The H. pylori Qualitative ELISA Kit was utilized in recent study! Scientists explored if Helicobacter pylori infection is a risk factor for developing non-alcoholic fatty liver disease in children. Check out the details and access the full findings below.


Abstract

Helicobacter pylori infection has been investigated as a potential risk factor for non-alcoholic fatty liver disease (NAFLD). Some studies suggest a possible link between the two conditions. The purpose of this study is to study the relationship between H. pylori infection and NAFLD in pediatrics and its relation to NAFLD grades. A case–control study to identify predictors of NAFLD and a comparative cross-sectional approach to determine factors affecting NAFLD grades were adopted. One hundred NAFLD children (ultrasound-based) and a control group of 100 non-NAFLD children were recruited. Both groups were evaluated by detecting H. pylori stool antigen. Immunoglobulin G antibodies to Cag A (cytotoxin-associated gene A), Vac A (vacuolating cytotoxin A), Gro EL (chaperonin Gro EL), HCPC (Helicobacter cysteine-rich protein C), and Ure A (Urease subunit A) were assessed in the serum of those with positive stool antigen. H. pylori infection was significantly higher in NAFLD children compared to the control group (64% versus 25%, p-value < .001). (NAFLD children showed higher Cag A and Vac A positivity (34, 10%) versus (2%, 0%) in the control group, respectively, p-value < .001). The regression model showed that H. pylori positivity (OR (odds ratio) = 5.021, 95% CI (confidence interval): 1.105–22.815), homeostatic model assessment of insulin resistance (Homa IR) (OR = 18.840, 95% CI: 3.998–88.789), waist percentile (OR = 1.184, 95% CI: 1.044–1.344), and triglycerides (OR = 1.029, 95% CI: 1.012–1.047) were predictors for NAFLD. Cag A positivity (OR = 2.740, 95% CI: 1.013–7.411) was associated with higher NAFLD grade (grade 2 fatty liver).

Conclusions: H. pylori infection could increase the risk of NAFLD in children. Triglycerides, waist circumference, and Homa IR are significant independent predictors of NAFLD.

Barakat, Sana, et al. “Is helicobacter pylori infection a risk factor for non-alcoholic fatty liver disease in children?” European Journal of Pediatrics, vol. 184, no. 1, 27 Nov. 2024, https://doi.org/10.1007/s00431-024-05867-y.


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iLite Assay Ready Cells

iLite® Assay Ready Cells are developed by our partners at Svar Life Science. The cell based solutions are based on the iLite technology, a cleverly engineered cell-based assay system with a dual reporter gene readout. They offer the ease of use and robustness of a Ligand Binding Assay and can be developed for virtually any pharmaceutical target and allows an easy, rapid and accurate test format for measurement and quantification of drug activity and immunogenicity.


Key Benefits

Assay Ready Format:
iLite cells are delivered as Assay Ready Cells, and stored at -80°C. There is no need for cell culturing and continuous maintenance of cells – just thaw and dilute before use in the assay.

Normalization Gene:
A second reporter gene used as an internal control will compensate for differences in cell number. In addition, it can be used to compensate for serum matrix effects, other complex matrices or if luciferase is sensitive to the compound you are analyzing.

Sensitivity and Specificity:
The sensitivity of iLite cells is enhanced through up-regulation of key components, such as the receptor and certain signaling pathway proteins. The up-regulation of receptors also confers a higher specificity, and this is enhanced through the use of chimeric transcription factors and synthetic reporter gene promoters.

These elements are used as a lock and key to transcription of the reporter gene – only the chimeric transcription factor can bind to the synthetic promoter, and endogenous transcription factors are thereby unable to trigger expression of the reporter gene. In this way, pathway cross-talk can be effectively minimized.

Precision:
The Assay Ready Format reduces assay variability in comparison with cells in culture. Traditionally, cell-based assays are known for their high variability, with %CV often over 25%. Robustness assays of iLite assays have shown that repeatability and intermediate precision are in the range of 4-11% CV, and sample accuracy between 92-107%.


Find all of the iLite products offered on the iLite Assay Ready Cells product page.


Free soluble RANKL (sRANKL), the unbound and bioactive form of the receptor activator of nuclear factor kappa-Β ligand, has gained attention for its roles beyond bone remodeling and immune responses. In the context of male reproductive physiology, free sRANKL interacts with its receptor RANK, which is expressed in testicular cells, including Sertoli and Leydig cells. This interaction influences several critical processes such as Sertoli cell maturation, germ cell survival, and testosterone synthesis. Sertoli cells provide essential support and nutrients to developing sperm cells, while Leydig cells are responsible for androgen production. Therefore, the presence and activity of free sRANKL in the testicular microenvironment are essential for maintaining optimal spermatogenesis and endocrine function.

Biomedica’s Free Soluble RANKL (sRANKL) ELISA Assay Kit was highlighted in 2 recent studies! Both studies identified RANKL (receptor activator of NF-kB ligand) signaling as a regulator of male reproductive function and discovering that Denosumab stimulates spermatogenesis in infertile men. Click below for the full publications, where you can find the abstracts and key findings!

Andreassen, Christine H., et al. “Denosumab stimulates spermatogenesis in infertile men with preserved Sertoli cell capacity.” Cell Reports Medicine, vol. 5, no. 10, Oct. 2024, p. 101783, https://doi.org/10.1016/j.xcrm.2024.101783.

Blomberg Jensen, Martin, et al. “Rankl regulates male reproductive function.” Nature Communications, vol. 12, no. 1, 23 Apr. 2021, https://doi.org/10.1038/s41467-021-22734-8.


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The Dopamine ELISA Assay Kit was featured in a new study that focused on the role of Vitamin D3 in the mitigation of sodium arsenite induced neurotoxicity in male rats. Check out the abstract and full text!


Abstract

Arsenic is associated with various neurological disorders, notably affecting memory and cognitive functions. The current study examined the protective effects of vitamin D3 (Vit. D3) in countering oxidative stress, neuroinflammation and apoptosis induced by sodium arsenite (SA) in the cerebral cortex of rats. Male Wistar rats were subjected to a daily oral administration of sodium arsenite (NaAsO2, SA) at a dosage of 5 mg/kg, along with 500 IU/kg of Vit. D3, and a combination of both substances for four weeks. The results indicated that Vit. D3 effectively mitigated the SA-induced increase in oxidative stress markers, thiobarbituric acid reactive substances (TBARS) and nitric oxide (NO), the decrease in antioxidants (reduced glutathione; GSH, superoxide dismutase; SOD, catalase; CAT, and glutathione peroxidase; GPx), as well as the increase in pro-inflammatory markers including, tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and amyloid-beta (Aβ)1–42. Furthermore, Vit. D3 reversed the alterations in the neurochemicals acetylcholinesterase (AchE), monoamine oxidase (MAO), dopamine (DA), and acetylcholine (Ach) and ameliorated the histopathological changes in the cerebral cortex. Moreover, immunohistochemical analyses revealed that Vit. D3 reduced the SA-induced overexpression of cerebral cysteine aspartate-specific protease-3 (caspase-3) and glial fibrillary acidic protein (GFAP) in the cerebral cortex of male rats. Consequently, the co-administration of Vit. D3 can protect the cerebral cortex against SA-induced neurotoxicity, primarily through its antioxidant, anti-inflammatory, anti-apoptotic, and anti-astrogliosis effects.

Abdou, Heba Mohamed, et al. “Role of vitamin D3 in mitigating sodium arsenite-induced neurotoxicity in male rats.” Toxicology Research, vol. 13, no. 6, 5 Nov. 2024, https://doi.org/10.1093/toxres/tfae203.


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The Progesterone ELISA Assay Kit was utilized in a recent publication! The publication explored menstrual effects on thermoregulation while exercising in the heat.  Check out the abstract and full text!


Abstract

Women may be challenged to maintain thermoregulation due to hormonal changes associated with the menstrual cycle. The purpose of this study was to assess the effect of the menstrual cycle phase on core temperature, hydration status, and perceived exertion while exercising under uncompensable heat gain. Eleven eumenorrheic women (24.4 ± 1.1 yrs, 65.7 ± 2.4 kg, 22.7 ± 1.5% body fat) walked for two 180-min trials in a heat chamber (35 °C and 30% relative humidity) during early-follicular (EF) and mid-luteal (ML) phases. Subjects completed three intervals of 50 min of exercise at 50% VO2max. Physiological strain index (PSI), core temperature (TC), perceived heat (PH), and rating of perceived exertion (RPE) were measured throughout both trials. Nude body weight (NBW) and blood samples were collected pre- and post-trial. Blood samples were analyzed for hematocrit (Hct), hemoglobin (Hb), serum estrogen, progesterone, and aldosterone. NBW showed a main effect of time (p = 0.002, ηp2 = 0.62). Aldosterone showed main effect of time (p = 0.004, ηp2 = 0.59) and phase (p = 0.014, ηp2 = 0.47), peaking post exercise in both EF and ML (527.6.1 ± 89.0 pg·mL−1 vs 827.4 ± 129.5 pg mL−1 respectively, p = 0.014). Estradiol and progesterone showed main effects of phase (p = 0.007, ηp2 = 0.53; p = 0.045, ηp2 = 0.30) but not time (p = 0.68, p = 0.32). TC showed main effect of time (p < 0.001, ηp2 = 0.89) and phase, peaking at 170 min (EF: 37.8 ± 0.1 °C vs. ML: 38.0 ± 0.1 °C, p = 0.032, ηp2 = 0.38). Main effect of time was seen for PSI (p = 0.002, ηp2 = 0.88), PH (p = 0.004, ηp2 = 0.66), and RPE (p = 0.026, ηp2 = 0.80). Sweat rate, Hct, Hb, and percent dehydration were not different between the phases. In conclusion, subjects demonstrated elevated Tc and basal aldosterone in ML corresponding with elevations in estrogen and progesterone. Aldosterone significantly increased following exercise in the heat but remained elevated in ML. These results indicate that elevated Tc during ML is maintained during exercise in the heat despite similar perceived heat and effort between phases.

Christison, Katherine S., et al. “Menstrual cycle effects on thermoregulation while exercising in the heat.” Journal of Thermal Biology, vol. 127, Jan. 2025, p. 104036, https://doi.org/10.1016/j.jtherbio.2024.104036.


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Osteoprotegerin (OPG) is a glycoprotein that plays a crucial role in regulating bone metabolism. It is a decoy receptor for the receptor activator of nuclear factor-kappa B ligand (RANKL), which is involved in the process of bone resorption. OPG is primarily produced by osteoblasts (bone-forming cells) but can also be found in other tissues like endothelial cells, smooth muscle cells, and certain immune cells.

OPG is an important regulator not just for bone metabolism but also in inflammation. It modulates immune cell activity, cytokine production, and tissue remodeling in response to inflammation. Elevated OPG levels can be a sign of ongoing inflammatory processes in diseases such as rheumatoid arthritis, atherosclerosis, and other autoimmune disorders.

Biomedica’s Osteoprotegerin ELISA Assay Kit (BI-20403) was highlighted in a recent study! The study assessed serum OPG levels during acute inflammatory states induced by a bacterial or viral infection in children. The researchers investigated whether OPG increases during acute inflammatory states and if its levels correlate with other biomarkers. Click below for the full publication, where you can find the abstract and key findings!

Giannakopoulos, Aristeidis, et al. “Osteoprotegerin in infection-induced acute inflammatory states in children.” Heliyon, vol. 10, no. 6, Mar. 2024, https://doi.org/10.1016/j.heliyon.2024.e27565.


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Fibroblast Growth Factor 23 (FGF-23) is a hormone primarily produced by osteocytes and osteoblasts in bones, playing a key role in regulating phosphate and vitamin D metabolism. It lowers serum phosphate levels by reducing phosphate reabsorption in the kidneys and suppresses the activation of vitamin D, thereby decreasing intestinal phosphate and calcium absorption. FGF-23 requires the co-receptor Klotho to bind to fibroblast growth factor receptors (FGFRs) and exert its effects, primarily in the kidneys. Dysregulation of FGF-23 is associated with several pathological conditions, making it a valuable biomarker for assessing phosphate balance and mineral metabolism.


image credit: https://www.kidney-international.org/


Why Measure FGF-23?

Measuring FGF-23 is essential for advancing research on phosphate metabolism, bone biology, and endocrine regulation. It provides insights into the mechanisms underlying phosphate homeostasis and the complex interplay between FGF-23, Klotho, and fibroblast growth factor receptors. FGF-23 is also a valuable marker for studying how mineral metabolism affects systemic processes, including cardiovascular function and aging. In experimental models, FGF-23 measurements help elucidate the effects of genetic mutations, dietary phosphate intake, and novel therapeutic interventions on phosphate regulation. Additionally, FGF-23 serves as a biomarker to explore the broader effects of mineral dysregulation on inflammation, oxidative stress, and metabolic disorders, enhancing our understanding of its role in health and disease.


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