Advance Bioanalytical Research With Us
Customized Bioanalytical Solutions
NorthernBio offers customized bioanalytical assays for molecular biology services and ligand binding assays for immunogenicity and biomarker analysis to support all phases of therapeutic development. Collaborating scientist-to-scientist, NorthernBio develops tailored solutions to accelerate the advancement of next-generation therapeutics.
Consult a Scientist
We are a team of scientists who value open communication and collaboration. We work closely with our sponsors to provide customized solutions and expert support.
Advanced Molecular Biology for Drug Development
Capabilities and Instrumentation
qPCR
Amplifies and quantifies specific DNA sequences in real-time using fluorescent dyes or probes to monitor the amplification process.
RT-qPCR
Quantifies RNA levels by reverse transcribing RNA to cDNA, followed by real-time qPCR amplification and detection.
dPCR
Partitions DNA samples into thousands of individual reactions to provide absolute quantification of target nucleic acids without relying on standard curves.
Stem-loop RT-qPCR for miRNA
Uses a stem-loop primer to reverse transcribe microRNAs (miRNAs) into cDNA, followed by qPCR for sensitive and specific quantification of small non-coding RNAs.
Methods
Methods are used for quantification of cell and gene therapeutics such as viral vector, LNP mRNA, small RNA (e.g. miRNA, siRNA), and cells (e.g., stem cell, CAR-T cells).
Instrumentation
QuantStudio 7 Flex Real-Time PCR Systems
QIAcuity One & Four - 5plex system for digital PCR
QIASymphony for automated DNA/RNA extraction
Nanodrop Spectrophotometer 8000
QIAgility Liquid Handling Robot
Precellys Tissue Homogenizer
Agilent Bioanalyzer
Azure 200 Imaging System
Method Development Timelines
Our expert team specializes in developing and validating advanced PCR-based assays, delivering customized solutions to meet your research needs. Consulting with one of our experienced study directors, a tailored timeline for method development can be proposed, accounting for assay complexity, analyte characteristics, and project requirements to ensure flexibility and precision. With a steadfast commitment to regulatory compliance and scientific rigor, we craft high-performance assays to deliver reliable results, advancing your research with efficiency and accuracy.
Immunoassays for Nonclinical Research
The NorthernBio team excels in immunoassay development and validation across a wide range of methodologies in support of nonclinical programs. We utilize several platforms to provide customizable solutions for immunoassay development and biomarker testing.
Capabilities and Instrumentation
Anti-Drug Antibody (ADA) assays for capsid or protein
Detect and quantify antibodies generated against therapeutic proteins or viral capsids, assessing immunogenicity in drug development.
Biomarker analysis - Neurofilament Light Chain
Assay measures neurofilament levels in biofluids, serving as a biomarker for neuronal damage in neurodegenerative diseases.
Biomarker analysis - Cytokine Multiplex Analysis
Simultaneously quantifies multiple cytokines in a sample, enabling comprehensive immune response profiling.
Biomarker analysis - Complement Analysis
Evaluates the activity or levels of complement system proteins, aiding in the study of immune-related disorders or therapeutic effects.
Custom ligand binding PK assays
Detect unique analytes in a variety of biofluids and tissues.
Instrumentation
Meso Sector 600MM
Spectramax iD5
Luminex 200
Frequently Asked Questions (FAQs) about Bioanalytical Services
What sort of assays does NorthernBio support?
NorthernBio routinely develops customized assays for molecular biology (qPCR, RT-qPCR, dPCR, stem-loop RT-qPCR) and ligand binding assays for immunogenicity, PK, and biomarker analysis (ADA, NfL, cytokines, and complements).
What instrumentation does NorthernBio utilize to support assay development and analysis?
NorthernBio operates on advanced technologies for bioanalytical support. For molecular biology assays, NorthernBio is equipped with QuantStudio 7, QIAcuity, QIASymphony, and Nanodrop Spectrophotometer platforms. For immunoassay development and analysis, NorthernBio works on Meso Sector 600MM, Spectramax iD5, and Luminex systems.
How long does PCR method development and validation take?
NorthernBio completes method development in about two weeks, or three weeks for a duplex RT-qPCR. Add roughly 1.5 weeks for method qualification or two weeks for core method validation. Unaudited reports follow in about four weeks and audited reports in about five, depending on assay complexity and analyte characteristics.
How is AAV biodistribution (qPCR) and Vector-derived gene expression (RT-qPCR) measured in preclinical studies?
NorthernBio uses qPCR, RT-qPCR, and digital PCR to measure vector DNA and transgene expression across tissues and biofluids, which is what most gene therapy biodistribution and persistence packages require. Sample processing can be tailored to each tissue type so the data holds up in a regulatory submission.
qPCR vs digital PCR: which is better for vector copy number?
Digital PCR partitions a sample into thousands of individual reactions and gives absolute quantification without a standard curve, which makes it the stronger option for low copy targets and vector copy number. qPCR is faster and less expensive and works well with a validated standard curve and adequate signal. NorthernBio runs both and will recommend the fit for your samples.
How are anti-drug antibodies measured?
NorthernBio develops, qualifies, and validates anti-drug antibody (ADA) assays for viral capsids, therapeutic proteins, and other formulation components such as PEG. Assays can be run on Meso Sector 600MM, SpectraMax iD5, and Luminex 200 platforms, with in-house biotin and SulfoTAG labeling of target molecules, including AAVs and proteins. Depending on assay requirements, NorthernBio can support formats ranging from homogeneous bridging assays to more complex approaches such as ACE, SPEAD, and PandA.
The same immunoassay group covers neurofilament light chain, cytokine multiplex, and complement biomarkers, as well as PK assays to quantitate administered or expressed therapeutic proteins and enzymatic activity.
Can you run bioanalysis if the in-life study is at another CRO?
Yes. Sponsors can ship samples to our Portage, Michigan laboratory for molecular biology and immunoassay analysis, regardless of where the in-life phase was conducted. Our team coordinates shipping conditions and chain of custody with the originating site before samples move.
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