At Accurant, we specialize in bioanalysis services that focus on three key areas: safety, exposure, and efficacy. Our team is dedicated to helping our clients assess the safety of their compounds, measure the level of exposure in various biological matrices, and evaluate their efficacy. Whether it’s large molecule bioanalysis, cell and viral-based therapy, oligonucleotide analysis, or small molecule bioanalysis, our expertise and cutting-edge technology ensure that we deliver the most accurate and reliable results. Trust us to provide you with the comprehensive bioanalysis services you need to make informed decisions about your drug development process.
We offer exposure assessment services for large molecule therapies to determine drug concentrations in biological matrices such as plasma, serum, or tissue. Our PK/PD analysis helps in determining the optimum dosing regimen for your drug candidates.
Our safety assessment services for large molecule therapies include the analysis of immunogenicity. We perform immunogenicity assays to detect and quantify the presence of anti-drug antibodies (ADA) that can affect drug efficacy and safety.
For a detailed overview of our services related to large molecule efficacy, please visit our efficacy page. Here we offer a comprehensive suite of assays and analyses to support your drug development programs.
Retroviral and lentiviral vectors are commonly used in CAR-T cell generation because of their high transduction rates and ability to achieve long-term stable transgene expression in T cells. We provide extensive exposure PK analysis for these therapies, which includes immunotyping and quantification of CAR-T cells using flow cytometry. We also use ddPCR and qPCR to quantify the transgene copy number for PK analysis.
Our services also include the analysis of laboratory modified oncolytic viruses, a promising form of immunotherpay that uses viruses to infect and destroy cancer cells. We can help assess the drug PK of oncolytic viruses using reliable techniques such as qPCR and ddPCR, ensuring the safety and efficacy of these therapies in clinical trials and commercialization. Trust us to provide accurate and comprehensive analysis of your oncolytic virus drug PK, so you can move forward with confidence.
Our bioanalysis team can help you evaluate the pharmacokinetics of your AAV-transgene drug. AAVs are small viruses that have become popular vectors for gene therapy because they are not known to cause disease in humans. By delivering transgene to target cells, AAV gene therapy aims to treat a variety of genetic and acquired diseases. At our laboratory, we use advanced methods such as qPCR and ddPCR to accurately quantify the PK of your AAV-transgene drug.
Our testing services encompass a board range of safety assessment, including viral and vector shedding studies, and viral titer assays.
We offer testing for humoral immunity. Explore our immunogenicity page for more information.
We offer cytokine release testing, which is a critical component in assessing the safety of CAR-T treatments.
Cytokines play a crucial role in mediating the efficacy of treatments, but can also lead to adverse effects if released in excess. Our testing is performed in both preclinical and clinical stages using a range of methods, including electrochemiluminescence, ELISA, and CBA using FACS. Our use of electrochemiluminescence is widely recognized in the clinical stage and is utilized by leading organizations such as Kite, NCI, and Juno to monitor cytokine storms for CAR-T cell therapy.
Our team utilizes the ELIspot assay to measure cellular immune responses, providing critical insights into the effectiveness of cell-based therapies and vaccine candidates.
We provide replicative competent lentivirus testing for retroviral vector therapies, as recommended by the FDA. Our testing is designed to detect any evidence of RCL occurrence during patient monitoring after infusion of the vector drugs or vector transduced cells. We utilize the most sensitive available methods, including qPCR and ddPCR, to detect RCR or RCL. For CAR-T drugs, we employ highly sensitive qPCR or ddPCR to detect the VSV-G gene, which serves as an indicator for potential RCL.
We offer insertion site analysis using next generation sequencing, which allows for precise localization of foreign DNA insertions in the genome and provides longitudinal assessment of clonality in engrafting cell populations after gene modification and transplantation. This analysis is a key tool to assess the biosafety of gene therapy vectors and the clonal tracking fate of genetically modified cells.
For a detailed overview of our services related to cell & viral based therapy efficacy, please visit our efficacy page. Here we offer a comprehensive suite of assays and analyses to support your drug development programs.
We offer PK analysis services for siRNA, a powerful tool in gene regulation and potential treatment for many human diseases. Our services include LC-MS/MS analysis and more sensitive stem-loop RT qPCR/ddPCR methods for accurate quantification of siRNA biological samples. Our expertise in siRNA PK analysis allows us to provide valuable insights into the pharmacokinetics of siRNA molecules, including their distribution, metabolism and excretion, and help guide the development of safe and effective siRNA-based therapies.
We offer PK analysis services for mRNA vaccines or drugs, which can be quantitated indirectly using RT qPCR/ddPCR. Our approach involves extracting mRNA from human or animal samples and synthesizing complementary DNA (cDNA) from it. The cDNA is then measured using qPCR/ddPCR to generate corresponding copy numbers of mRNA in the samples. With our expertise in mRNA PK analysis, we can provide accurate and reliable measurements of mRNA levels in biological matrices and help guide the development of mRNA-based therapies.
Our oligonucleotide bioanalysis services offer a range of analytical techniques to support the development and evaluation of antisense oligonucleotide (ASO) therapeutics. ASOs are short, synthetic, chemically modified single-stranded nucleotides that have the potential to target any gene product of interest, modulating the expression of problematic genes. To quantify oligonucleotides in human or animal samples, we offer several analytical methods, including LC-MS/MS, hybridization ELISA, and stem-loop RT qPCR/ddPCR, which provide high sensitivity and specificity. Our expert team can work with you to design and implement a customized assay that meets your specific needs and requirements.
For a detailed overview of our services related to oligonucleotide efficacy, please visit our efficacy page. Here we offer a comprehensive suite of assays and analyses to support your drug development programs.
We offer exposure assessment services for smallmolecule therapies to determine drug concentrations in biological matrices such as plasma, serum, or tissue. Our PK/PD analysis helps in determining the optimum dosing regimen for your drug candidates.
For a detailed overview of our services related to small molecule efficacy, please visit our efficacy page. Here we offer a comprehensive suite of assays and analyses to support your drug development programs.
New Jersey
259 Prospect Plains Rd
Cranbury, NJ, 08512
732.783.7398
bd@accurantbiotech.com
Shanghai
Room 505, Floor 5
No. 8, Jiafeng Rd.
Free Trade Zone
Shanghai, China
Ningbo
Floor 4, Building A5
No. 587, Juxian Rd.
High-Tech Zone
Ningbo, China
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