November 8, 2024

Developing and validating a neutralizing Ab assay to AAV9 based on cell-based platform

China Bioanalysis Forum 2024 -- Gene therapy brings the promise of a one-time treatment option that will fix the errors in patient genetic coding. Recombinant viruses are highly efficient vehicles for in vivo gene delivery. Adeno-associated virus (AAV) is one of the most actively investigated delivery tool in clinical gene therapy owing to its minimal pathogenicity and ability to establish long-term gene expression in different tissues. Assessment of the neutralizing antibodies (NAbs) of AAV in patients prior to/after systemic gene therapy administration is an important consideration regarding efficacy and safety of the therapy.
November 8, 2024

Minimizing target interference in PK assays: An approach for sample heat pre-treatment

China Bioanalysis Forum 2024 -- Quantitation of total levels of monoclonal antibody (mAb) biotherapeutics in serum using ELISA may be hindered by soluble targets. Interfering molecules can form complexes with the analyte and inhibit the specific binding characteristics used for either capture or detection of the analyte in an assay. Based on Bead-Extraction and Heat-Dissociation (BEHD) which uses heat pre-treatment to minimize drug interference in ADA assay when the drug with lower melting temperature than full 150-kDa antibody (Xu et al. Immunological Methods, 2018), we hypothesized that target interference in PK assay can be dissociated or removed by sample heat pre-treatment. 
November 8, 2024

Quantitative bioanalysis of oligonucleotides in tissue

China Bioanalysis Forum 2024 -- An antisense oligonucleotide (ASO) is a single-stranded ribonucleotide therapeutic, typically 16-20 nucleotides long, designed to bind complementary to the target RNA via Watson-Crick base pairing. Determination of oligonucleotides in biological tissues yields information which assists investigators in pharmacokinetic studies and may help to avoid potential organ toxicity. Compound A, a novel unconjugated ASO was designed to treat chronic hepatitis B for a functional cure. Through a global development strategy, Compound A is advancing rapidly towards the goal of HBV cure. To support a toxicity study of Compound A, a robust method was set up for the quantification of Compound A in different types of tissue homogenate, including kidney, liver, spleen, placenta, milk and in different species including mouse, monkey and rabbit.
October 23, 2024

Clinical considerations of drug testing in the primary care setting

Drug testing plays a critical role in monitoring patients who are prescribed controlled substances, including opioid pain medications, anti-anxiety medications, stimulants and drugs to treat substance use disorder. Testing choices have expanded in recent years and choosing the most appropriate drug testing involves considering many factors. Join Labcorp’s toxicology experts to gain insights into the fundamentals of clinical drug testing to help inform patient treatment decisions.
November 5, 2024

What to know about ocular cell and gene therapies

Cell and gene therapy (CGT) development for the eye differs from CGT development for other parts of the body. Discover more of the unique traits, regulatory guidelines and strategies necessary for ocular CGTs in our new Cell and Gene Therapy Answers video.
November 6, 2024

Assessing infiltrating lymphoid activation state in human samples via a new 30-color spectral flow cytometry panel

SITC 2024 -- Flow cytometry is a common method to assess immune cell infiltration into tumors. Spectral flow cytometers are now being used to develop larger antibody panels to increase the number of immune markers analyzed. With a focus on immunotherapy and adoptive cell therapy, we have developed the 30-color Spectral CompLymphocyte™ Panel using the Cytek® Aurora Spectral Flow Cytometer. The panel backbone includes viability and 10 lineage markers to measure live T, NK and B cell subsets. Nineteen additional functional markers enable the characterization of activation, exhaustion, cytotoxicity and proliferation in each subset, plus memory T cell subset delineation.
November 3, 2024

Replenishment of nutrients via iron-rich treats after blood collection in canines

National AALAS 2024 -- In the realm of animal research, the process of blood collection is a crucial step for obtaining necessary data required in the drug development process. Although each individual collection may seem relatively small, the cumulative impact may become significant when multiple time points or multiple blood samples are required. This rapid accumulation may result in a continuous loss of red blood cells (RBC) without adequate replenishment, ultimately leading to acute anemia in animals. This could potentially influence study data. The consequences of anemia and/or iron deficiency, stemming from continuous blood loss, manifest in various clinical observations such as lethargy, fatigue, pale mucous membranes and more. It is noteworthy that the stress induced by repeated collections alone can contribute to these symptoms. Most importantly, these clinical signs may erroneously be attributed to the test article rather than recognizing them as outcomes of the routine demands for data collection. Larger study designs, such as toxicokinetic (TK) studies may require higher blood volumes collected more frequently, increasing the possibility of these consequences. To address this issue and uphold the optimal health and safety of laboratory animals, we propose the implementation of an evidence-based approach. Specifically, we advocate for supplementing animals with an iron-rich treat immediately after blood collection. This implementation serves a dual purpose – rewarding the animals for positive behavior during the collection process and efficiently replenishing the lost RBC. By doing so, we aim to mitigate the possible adverse effects of repeated blood collections, ensuring accurate research outcomes while prioritizing the well-being of the laboratory animals. 
November 3, 2024

Artificial intelligence: A new tool to enhance animal welfare and research outcomes?

National AALAS 2024 -- Timely provision of veterinary care, through proactive monitoring conducted by knowledgeable and skilled research professionals, is an essential element of all high-quality animal care and use programs. To complement these activities, we have successfully developed and validated a nonhuman primate (NHP) welfare monitoring tool that uses artificial intelligence (AI) technology to identify when an animal may need veterinary care.