Analytical Assays

Introduction

Virovek offers a comprehensive suite of cutting-edge analytical assays designed to support the development, characterization, and quality control of viral vectors and gene therapies. Our services include:

AAV Aggregation Assay via Dynamic Light Scattering (DLS)
Determine the stability of your AAV vectors using our DLS-based aggregation assay. This cutting-edge method measures particle size distribution and detects aggregates in real-time, thus ensuring that your viral vectors maintain optimal integrity and performance for downstream applications.

AAV Capsid ELISA
Measure AAV capsid titers with exceptional sensitivity and reproducibility using our enzyme-linked immunosorbent assay (ELISA). This robust method detects capsids of multiple serotypes, thus providing critical data for vector quantification and quality control in gene therapy workflows.

AAV Sequencing
Verify the genetic accuracy of your AAV vectors through high-throughput next-generation sequencing. This assay delivers sequence confirmation, identifies potential mutations and ensures that your therapeutic constructs are error-free.

AAV TCID50 Assay
Determine the infectious titer of you AAV vectors using the Tissue Culture Infectious Dose 50 (TCID50) assay. This cell-based method quantifies the number of functional viral particles, which provides a reliable metric for the infectivity and potency of your products.

Adenoviral Titer Assessment (Quantitative PCR, Plaque Assay)
Accurately quantify adenoviral titers using two complementary approaches: quantitative PCR (qPCR) for rapid genome copy number determination and the classic plaque assay for infectious unit measurement. Together, these assays provide a comprehensive profile of your adenoviral preparations.

Agarose Gel Electrophoresis
Visualize and assess the integrity of nucleic acids using our agarose gel electrophoresis service. This straightforward yet powerful technique ensures that your samples meet genomic size and integrity criteria with clear, interpretable results.

Baculoviral Titer Determination (Quantitative PCR, Infectivity Using A Baculovirus-Inducible GFP Cell Line)
Precisely measure baculovirus titers using qPCR for genome quantification and assess infectivity with the help of a baculovirus-inducible GFP-expressing cell lines. These methods are ideal for optimizing baculovirus-based AAV production systems.

dPCR (Digital PCR)
Achieve absolute quantification of nucleic acids using the unmatched accuracy of digital PCR. This cutting-edge technology partitions samples into thousands of reactions and delivers precise copy number data without relying on standard curves. It is perfect for low-abundance targets.

Empty/Full Capsid Analysis via Capillary Electrophoresis
Distinguish between empty and genome-containing AAV capsids using our advanced analytical platform. This assay provides critical insight into vector quality and packaging efficiency, thus enhancing the therapeutic potential of your AAV products.

Endotoxin Assay
Ensure the safety of your products by utilizing our sensitive endotoxin detection assay. Using the gold-standard Limulus Amebocyte Lysate (LAL) method, we quantify bacterial endotoxins to meet stringent regulatory requirements.

Flow Cytometry
Analyze cellular responses and vector transduction efficiency with our state-of-the-art flow cytometry service. This high-resolution technique offers multi-parameter analysis of cell populations, thus advancing your research and quality control efforts.

Lentiviral p24 Titer Determination
Quantify lentiviral particles using our p24 ELISA assay. By determining the concentration of p24 capsid proteins, this method delivers rapid and reliable measurement of lentiviral titers for consistent production and application.

qPCR (Quantitative PCR)
Amplify and quantify DNA or RNA targets in real time using our qPCR assay. This highly sensitive and versatile tool supports a range of applications, from viral genome quantification to gene expression analysis, with short turnaround times.

Residual Host Cell DNA
Detect and quantify residual host cell DNA in your products using our highly sensitive assay. This critical test ensures compliance with regulatory standards, safeguarding the quality of your therapeutic products.

Residual Host Cell Protein
Monitor host cell protein impurities with our precise detection assay. Using advanced immunological and/or mass spectrometry-based methods, we can help you meet safety and quality benchmarks for clinical products.

Replication Competent AAV (rcAAV)
Assess the presence of replication-competent AAV (rcAAV) in your vector preparations using our rigorous testing methods. This essential safety evaluation minimizes clinical risks by confirming the absence of replication competent virus.

SDS-PAGE & Western Blot
Characterize protein profiles and confirm target expression using SDS-PAGE and Western Blot analysis. This dual approach separates proteins by size and verifies their identity with the help of specific antibodies, ensuring the purity and identity of your biological samples.

Whole Plasmid Sequencing
Validate your plasmid constructs using comprehensive whole plasmid sequencing. This assay provides an end-to-end sequence confirmation, detecting insertions, deletions, or mutations to guarantee the integrity of your genetic tools.

Collectively, these assays offer a robust toolkit for characterizing viral vectors, ensuring product quality, and meeting regulatory requirements, thus making Virovek your trusted partner in achieving your gene therapy goals.

The World’s Most Efficient Large-Scale AAV Manufacturing System

Virovek’s patented BAC-TO-AAV technology has the capability of generating up to 1E+17vg of adeno-associated virus in a single run. Learn more about our technology platform and explore a wide range of applications.

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