Bioanalytical Services
NorthernBio’s laboratory provides gene therapy bioanalysis, immunogenicity testing, manufacturing QC, and oligonucleotide bioanalysis for sponsors advancing gene, cell, and RNA programs, whether or not the in-life phase of your study is with us.
Gene Therapy Bioanalysis
NorthernBio measures biodistribution, shedding, vector genome levels, and transgene expression across tissues and biofluids using qPCR, RT-qPCR, and digital PCR. Digital PCR partitions each sample into thousands of reactions for absolute quantification without a standard curve, which makes it the stronger choice for low copy targets. Method development typically takes about two weeks, and sample processing is tailored to each tissue type so the data holds up in a regulatory submission.
Capabilities:
- Biodistribution
- Shedding
- Vector genome quantification
- Transgene expression
- qPCR
- dPCR
Ship Samples From Any CRO
Sponsors can send samples to our Portage, Michigan laboratory regardless of where the animal phase was conducted. Our team coordinates shipping conditions and chain of custody with your originating site before samples move.
Gene Therapy Immunogenicity
NorthernBio develops, qualifies, and validates anti-drug antibody assays against viral capsids, transgene products, and therapeutic proteins. In-house biotin and SulfoTAG labeling of AAVs and proteins supports formats from homogeneous bridging assays to ACE, SPEAD, and PandA approaches.
Capabilities:
- ADA assays
- Anti-capsid antibodies
- Anti-transgene antibodies
Consult a Scientist
Tell us about your program and our bioanalytical team will walk you through assay selection, timelines, and what a validated method looks like for your samples.
Manufacturing QC Testing
NorthernBio supports gene therapy manufacturing with residual DNA and residual plasmid testing, mycoplasma testing, stability studies, and adventitious agent testing, using the same PCR platforms and scientific team behind our bioanalytical work.
Capabilities:
- Residual DNA
- Residual plasmid
- Mycoplasma
- Stability studies
- Adventitious agent testing
Oligonucleotide Bioanalysis
NorthernBio quantifies ASOs, siRNAs, and miRNAs and tracks therapeutic RNA biodistribution using RT-qPCR and stem-loop RT-qPCR. Duplex RT-qPCR method development typically completes in about three weeks.
Capabilities:
- ASO analysis
- siRNA analysis
- miRNA analysis
- Therapeutic RNA biodistribution
- RT-qPCR
Biomarker Sciences
The same immunoassay group runs neurofilament light, cytokine multiplex, complement activation, and protein biomarker assays on MSD and Luminex platforms, alongside PK assays for administered or expressed therapeutic proteins.
Capabilities:
- Neurofilament light
- Cytokines
- Complement activation
- Protein biomarkers
- MSD and Luminex assays
Instrumentation & Capabilities
Molecular Biology Platforms
- QuantStudio 7
- QIAcuity (digital PCR)
- QIASymphony
- Nanodrop
- Spectrophotometer
Immunoassay Platforms
- Meso Sector 600MM
- SpectraMax iD5
- Luminex 200
Timelines
- Method development in about two weeks (three for duplex RT-qPCR)
- Method qualification in about 1.5 weeks
- Core method validation in about two weeks
- Audited reports in about five weeks
Partner With Us
Let’s work together to get
your program the data it needs.
Join us in the pursuit of better lives through scientific innovation. Learn how NorthernBio’s bioanalytical team can support your program, from method development through validated, regulatory-ready data.