Deep Immuno-Oncology & Rare Disease Therapeutic Expertise

Q: Do you have experience in our indication?

Almost certainly at the platform level, which is where bioanalysis lives: 200+ investigational drugs have run here across oncology, immunology, cardiovascular, CNS, rare disease, ophthalmology and more. Name the molecule, matrix and readout, and we will tell you plainly what we have run that is closest.

Q: Our rare disease study has tiny sample volumes. Can you work with that?

Yes, and it starts at design: assays tuned for minimal volume, feasibility runs before commitments, and scheduling built around patient visits. Scarce samples get one chance, and the plan is written to respect that.

Q: Can you support combination and multi-analyte oncology studies?

Yes. Multiplexed cytokine panels, parallel PK assays and tiered immunogenicity run side by side under one LIMS, so a combination protocol reads as one dataset rather than three vendors’ spreadsheets.

Q: What can you measure for cell and gene therapy programs?

Biodistribution and vector shedding by qPCR and droplet digital PCR, transgene expression, immunogenicity against vector and transgene, and cytokine safety panels. If the readout is unusual, use the feasibility form above; we will say what it takes, or say no fast.

De-Risk Your Bioanalysis, Whatever The Therapeutic Area.

If your compound is not on the published lists, ask; we may have run it already.

Ten Therapeutic Areas Running In The Lab Today, With The Historic Depth In Oncology
Named Methods Already Built And Run, From Oncology Drugs And ADCs To CNS Agents
200+ Investigational Drugs Supported, Discovery Screens Through Pivotal Trials
Central Lab Support Under The Same Roof, Study Kit Builds, PBMC Processing, Sample Logistics And Storage

“NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism.”

Co-Founder, Biotech & University PI

Regulated And Inspected By:

Therapeutic Areas Already Covered

500+ Small Molecules And Peptides Run

50+ Large Molecule Therapeutics Run

200+ Investigational Drugs

Oncology The Deepest Of The Ten Areas

Why A Bioanalytical Lab Can Honestly Say Any Indication

Ten areas run through the lab today; the historic depth is oncology, aligned with our sponsors’ research interests.

Oncology
Immuno-oncology
Infectious disease
Autoimmune and inflammation
Metabolic
Rare disease
Neurology
Vaccines
Cardiovascular
Ophthalmology

An assay does not know what disease it serves. What changes across indications is the molecule, the matrix, the sensitivity floor and the sample logistics, and those are platform problems this lab solves daily across twelve LC-MS/MS systems and a full ligand binding, molecular and cell-based fleet. That is why the honest claim is agnostic: if the molecule and matrix are in range, the indication rarely adds analytical risk. What an indication does change is study design pressure, and that is where the deliberate focus below comes in.

Rare Indication? We Match the Bioanalysis to It.

Tell us the disease and the readout.

Immuno-Oncology, Multiplexed Readouts On Unforgiving Timelines

Cytokine panels, tiered immunogenicity, receptor occupancy and cell-based potency carry checkpoint and combination programs, where multiplexed readouts meet unforgiving timelines.

Representative work · A low-abundance cytokine that read below LLOQ on standard panels, rebuilt as a custom ELISA for the CRS call.

Rare Disease, Precious Samples And Feasibility First

Small cohorts and precious samples change the math: feasibility-first design, sensitivity tuned to tiny volumes, and scheduling built around patient visits rather than instrument convenience.

Representative work · Nine drugs and four metabolites validated in plasma and breast milk, whose fat varies feed to feed.

Cell & Gene, The Molecular Floor Was Built For This

qPCR and droplet digital PCR carry biodistribution and shedding, immunogenicity work watches the response to vector and transgene, and cytokine panels watch safety. The molecular floor was built with this class in mind.

Representative work · Biodistribution and shedding for a gene therapy IND, with vector copy number in lentivirus-transduced T cells.

Bioanalytical Methods That Follow Your Molecule, Blood To Brain

Our platforms adapt to the matrix and the chemistry, and every species and matrix below is one we have handled ourselves, hands on, not in principle.

SpeciesHuman samples from Phase I to IV, plus mouse, rat, rabbit, dog, cat, pig and minipig, goat, sheep, cow, horse, deer, prairie dog, chicken and non-human primate.

Blood and cellsPlasma, serum, whole blood, dried blood spots, red blood cells and PBMC.

TissueTumor, liver, lung, kidney, brain, colon, skin, lymph node, arterial and ocular tissue, and bone allograft.

FluidsUrine, CSF, breast milk, tears, synovial fluid, aqueous humor, nasal swab extract, vaginal fluid and excreta.

Ex vivo organsPerfusate, bile, dialysate and tissue from ex vivo perfused human and porcine organs.

Cell systemsCell lysates, culture media, 3D and co-culture models, cell therapy products, and DNA and RNA extracts.

Methods extend to new species and matrices during development.

Run Already, From Abemaciclib To Cas9

Named methods across small molecules, biologics, new modalities and biomarkers; ask about yours.

Small molecules

Oncology and supportive care

abemaciclib · anastrozole · azacitidine · bendamustine · capecitabine · carboplatin · cisplatin · copanlisib (with M1) · cytarabine · doxorubicin (with doxorubicinol) · everolimus · exemestane · floxuridine · fludarabine · 5-fluorouracil (with DHFU, FUR) · gefitinib · gemcitabine · ibrutinib (with M37) · idelalisib · irinotecan (with SN-38, SN-38G) · letrozole · leucovorin · mesna · methotrexate · niraparib · oxaliplatin (with DACH-Pt) · paclitaxel · pemetrexed · plerixafor · regorafenib · romidepsin · ruxolitinib · selinexor · sorafenib · tamoxifen · umbralisib · vemurafenib · venetoclax · vinorelbine · vorinostat · zanubrutinib

CNS, pain and anesthesia

acetaminophen (with glucuronide, sulfate, NAPQI) · alfentanil · baclofen · bupivacaine · buprenorphine (with norBUP, glucuronides) · clonidine · cyclobenzaprine · dexmedetomidine · fluoxetine · gabapentin · guanfacine · haloperidol · indomethacin · ketamine · lidocaine · lurasidone · meloxicam · morphine (with M3G, M6G) · naproxen · nicotine · omaveloxolone · quetiapine (with 4 metabolites) · rocuronium · THC (with hydroxy-THC) · venlafaxine (with O-desmethyl)

Anti-infectives

acyclovir · amodiaquine (with desethyl-AQ) · brincidofovir · ciprofloxacin · dolutegravir · efavirenz · emtricitabine · enrofloxacin · famciclovir · gentamicin · ivermectin · lamivudine · lumefantrine · moxifloxacin · nevirapine · penciclovir · pyrvinium · remdesivir (with GS-441524) · tenofovir · valacyclovir

Cardiovascular, hematology, metabolic and GI

adenosine · aminocaproic acid · aprepitant · aspirin (with salicylic acid) · digoxin · dofetilide · elafibranor · losartan · low-molecular-weight heparin · metformin · omeprazole · osilodrostat · rosuvastatin · sacubitril/valsartan (with sacubitrilat) · sildenafil (with N-desmethyl) · tetrahydrobiopterin · tranexamic acid · valsartan · vardenafil

Immunology, transplant, respiratory and dermatology

baricitinib · cyclosporine · desloratadine · dutasteride · loratadine · minoxidil · nintedanib · pimecrolimus · pirfenidone · pseudoephedrine · sirolimus · tacrolimus · tofacitinib · tretinoin

Probe drugs, imaging agents, excipients and natural products

caffeine (with paraxanthine) · dextromethorphan (with dextrorphan) · midazolam (with 1-OH-midazolam) · diatrizoate · gadoterate · iodixanol · iopromide · Ca-DTPA · DOTA chelator · HP-β-cyclodextrin · curcuminoids · EGCG · triptolide · glycyrrhetinic acid

Biologics and new modalities

Antibodies, bispecifics and conjugates

alemtuzumab · atezolizumab · bevacizumab · cetuximab · daratumumab · denosumab · durvalumab · eculizumab · golimumab · infliximab · ipilimumab · natalizumab · nivolumab · obinutuzumab · pembrolizumab · ranibizumab · rituximab · tocilizumab · trastuzumab · anti-hMPV antibody · cytokine-targeting mAb · enzyme-targeting mAb · growth factor-targeting mAb · anti-oxLDL mAb · interleukin-targeting bispecific · T-cell engager bispecific · antibody-based degrader · peptide-drug conjugate with free MMAE · ligand-protein conjugates

Proteins and peptides

abatacept · aflibercept · anakinra · erythropoietin · pegfilgrastim · Nogo receptor Fc fusion · half-life-extended protein · renin · insulin lispro · liraglutide · semaglutide · octreotide · oxytocin · palmitoyl peptides · collagen types I to VII

Oligonucleotides, cell and gene therapy

antisense oligonucleotide · mipomersen · avacincaptad pegol (aptamer, hybridization assay) · peptide nucleic acid · SM-102 LNP lipid · AAV capsid · lentiviral vector · anti-CD19 CAR (scFv) · anti-CD20 CAR (scFv) · Cas9

Biomarkers and cytokines

Interleukins

IL-1α · IL-1β · IL-2 · IL-4 · IL-5 · IL-6 · IL-8 · IL-10 · IL-12p70 · IL-13 · IL-17A · IL-21 · IL-23

Chemokines

MCP-1 · MIP-1α · MIP-1β · RANTES · eotaxin · IP-10 · MIG · GRO-α (KC) · SDF-1α · TARC

Interferons, TNF and growth factors

IFN-α · IFN-β · IFN-γ · TNF-α · sTNF-RI · GM-CSF · G-CSF · LIF · VEGF-A · TGF-β1 · EGF · BDNF

Immune markers, antibodies and viral antigens

TSLP · BAFF · granzyme B · CRP · tryptase · autoantibodies to insulin · autoantibodies to TSHR · cardiac autoantibodies · HAMA · antibodies to SARS-CoV-2 spike · HIV p24

Metabolic and endocrine

insulin · proinsulin · C-peptide · GLP-1 (active and total) · GIP · PYY · ghrelin · leptin · pancreatic polypeptide · IGF-1 · aldosterone · cortisol · cortisone · melatonin (with 6-OH-melatonin)

Cardiovascular, kidney and coagulation

NT-proBNP · BNP · cardiac troponin I · CK-MB · cGMP · endothelin-1 · angiotensin II · ICAM-1 · KIM-1 · NGAL · clusterin · β2-microglobulin · cystatin C · creatinine · uric acid · D-dimer · fibrinogen · thrombin-antithrombin complex · FXIIa

Neurology, fibrosis, stress and PD markers

NfL · GFAP · Aβ1-40 · phospho-tau (Thr217) · hyaluronic acid · TIMP-1 · PIIINP · MMP-9 · hydroxyproline · uPA · 4-HNE · 3-nitrotyrosine · 8-OHdG · allantoin · DNA adducts · ferritin · HSP70 · GRP78 · lactic acid · H3K27me3 · RYK

Endogenous small molecules

dopamine · epinephrine · DOPAC · homovanillic acid · thromboxane B2 · 11-dehydro-TXB2 · 2,3-dinor-6-keto-PGF1α · cholesterol · 7-dehydrocholesterol · 4β-hydroxycholesterol · 27-hydroxycholesterol · vitamin D · retinol · folates · riboflavin · vitamin E metabolites · omega-3 fatty acids · free fatty acids · sphingoid bases · amino acids · methylmalonic acid · homocysteine · UDP-galactose

Biomarker panels run on MSD V-PLEX, U-PLEX, S-PLEX and R-PLEX, Luminex, ELISA and ELISpot, in human, mouse, rat and canine serum, plasma, PBMC supernatant and tissue. These lists are not exhaustive, and some assays are research use only.

What Sponsors Say Across Indications, Verbatim

Quoted with permission, names withheld. Yours would be too.

Unusual Endpoint? We Check Bioanalytical Feasibility.

Share the readout. We say what it takes.

VP, PK PD Analysis
★★★★★
NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.
Sr. Dir., Bioanalytical Development & QC
★★★★★
NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms.
Director, PK
★★★★★
We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.
Dir., Bioequivalence Testing
★★★★★
Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.
SVP Quality & Compliance, Biotech
★★★★★
We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.
VP, Development Operations
★★★★★
NorthEast BioLab’s scientists deliver high-quality data on time and within budget.