Small & Large Molecule Bioanalysis Services

Q: How is this page different from Bioanalytical Assay Development and Validation?

This page routes: molecule in, mapped program out. That page builds: once the routing names a method, its development, validation and transfer happen there, with the regulatory detail and timelines that belong to it. If you already know exactly which assay you need, go straight there or to the platform page; if you are holding a molecule and a deadline, start here.

Q: We are not sure which platform our molecule needs. Is that a problem?

It is the normal starting point and the reason this page exists. Modality, matrix, species and the decision the data feeds are enough for a senior scientist to map the endpoints and platforms, and the quote names the reasoning rather than hiding it.

Q: Can one lab really cover both our small molecule and our biologic?

This year the work here splits nearly evenly between small and large molecules, and about a fifth of it comes from sponsors running multiple streams at once. One accession feeding LC-MS, immunoassay, flow and PCR endpoints is routine practice, not a brochure claim.

Q: What about novel modalities?

ADCs, bispecifics, oligonucleotides, LNPs, AAV programs and cell therapies all have routed homes here: hybrid LC-MS for conjugates, ion-pair and hybridization methods for oligos, ddPCR for vectors, flow for cellular kinetics. The modality cards above link each one to its platform page.

Q: Which quality tier will our work run under?

The tier follows the decision the data feeds: fit-for-purpose for exploratory work, GLP for regulated nonclinical studies, GCLP for clinical samples and CLIA where a result drives an individual patient decision. The tier is named per endpoint in the quote, and the GLP and Quality pages carry the detail.

Q: Are you Northeast Bioanalytical Laboratories?

We are NorthEast BioLab, the bioanalytical CRO in Hamden, Connecticut, founded in 2003, and this is the page sponsors usually mean when they search the name. The company story lives on the About Us page; the lab itself is on the Facility & Equipment page.

De-Risk Your Bioanalysis, Small or Large Molecule.

Brief PhDs on your modality, matrix and study.

Nearly Half Small Molecule, Nearly Half Large: This Year’s Work Splits Down The Middle
PK, Immunogenicity, Biomarker And Molecular Endpoints Routed From A Single Accession
Twelve LC-MS, MSD, Luminex, ELISA, Flow, ELISpot And ddPCR Under One Set Of SOPs
700+ Sponsor Studies And 500+ Custom Methods Across Every Modality Sponsors Make

Regulated And Inspected By:

Start From Your Molecule, And The Program Follows From That

Choosing between MSD and LC-MS is our job, not yours. Describe the program, and every endpoint gets a platform, a tier and a clock.

Small Molecules, Metabolites And Prodrugs

PK and TK by LC-MS/MS in plasma, urine, CSF and tissue, metabolites quantified alongside
From discovery exposure checks to regulated bioequivalence, the same fleet carries all of it

Monoclonal Antibodies, Proteins And Peptides

PK by MSD and ELISA, immunogenicity tiers beside it, hybrid LC-MS when antibodies limit
From first in human through pivotal, the endpoint family grows without changing buildings

Antibody Drug Conjugates And Bispecific Formats

Total and conjugated antibody with free payload by hybrid LC-MS, domain-specific formats
The hardest routing case there is, which is why the worked example below walks one through

Gene And Cell Therapies, AAV, LNP And CAR-T

Vector copy number, biodistribution and shedding by ddPCR, transgene expression by qPCR
Pre-existing anti-capsid serostatus and cellular kinetics by flow, routed from one draw

Oligonucleotides: siRNA, ASOs, PMOs, Aptamers

Ion-pair LC-MS and hybridization ligand binding, matched to length, chemistry and matrix
Biodistribution in tissue panels when the program needs it, on the same accession chain

Biomarkers Routed To Their Own Discipline

Endogenous analytes have their own tiering and their own page: our Biomarker CRO practice
The 851 item assay menu is checked first there, so existing methods never rebuild at cost

How A Molecule Gets Routed Through Our Building, In Order

We map endpoints to platforms, name the tier plainly in the quote and keep one custody chain for every modality.

Name The Molecule And The Decision

Modality, matrix, species and the decision the data feeds, told to us in plain sentences
All Services
Endpoints Mapped To Platforms

PK, immunogenicity, biomarker and molecular endpoints matched to the platform each needs
All Platforms
The Tier Named Honestly

Fit-for-purpose, GLP, GCLP or CLIA, set by what the data must defend, stated in the quote
GLP Laboratory
The Method Built Or Transferred

New build, kit qualification or transfer-in, handed to the assay development team
Bioanalytical Assay
Samples Flow On One Custody Chain

Kits, accession, aliquoting and storage through the central lab, one Watson LIMS record
Central Lab Services
The Study Runs, Preclinical Or Clinical

IND enabling work or trial support picks up the routed program without a second vendor
Preclinical CRO

Ready To Start? Scope Your Bioanalysis.

Tailored bioanalysis quote in 2 days.

Four Endpoints Routed Through One Building Instead Of Four Vendors

Split-vendor programs fail at the handoffs: transfer files, unit conventions and timing. One lab, one LIMS and one QA unit close those gaps.

Talk Science First? Ask Our Bioanalysis Experts.

Discuss modality, platform and matrix.

Nearly half of this year’s work is small molecule and nearly half large, with a fifth of it from sponsors running multiple streams at once, so cross-modality routing is the daily norm.
Twelve LC-MS systems beside immunoassay, flow and PCR fleets mean a program that spans modalities never spans vendors, so no second lab or second courier chain enters your study.
Quality is the floor across every route: five FDA inspections, an independent QAU and 85+ SOPs on one eQMS, so switching platforms mid-program never means switching quality systems.

700+Sponsor Studies Across Small And Large Molecules Alike

500+Custom Methods Spanning Small, Large And Novel Modalities

What Does Bioanalysis Cost Here?

Per assay and per sample with no minimum batch size, quoted per endpoint at the tier each endpoint actually needs, so a two-endpoint pilot and a four-endpoint pivotal are priced on what they use. Small projects run signature to results in two to four weeks, and a senior scientist replies within two business days.

Your Cost Cannot Move Mid-Study

The quote you approve is the price you pay. Cost cannot move mid-study without an SOW addendum you have already approved, which matters most when one routed program spans platforms, tiers and years.

Sponsors Who Brought One Molecule And Stayed For The Program

Of the 100+ sponsors we serve each year, one in three stays past a third year, across 700+ studies and counting.

VP, Bioanalytical Development

NorthEast BioLab is the most responsive and thorough bioanalysis lab services CRO.
VP, Clinical Stage Biotech

The ability to work with our timelines to meet deadlines is very much appreciated.
VP, Clinical Stage Biotech

The services are customized to our specific needs as opposed to standard packages.
President & CSO, Biotech

We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data
Executive, Clinical Stage Biotech

There was an issue with half-life extrapolation, and NorthEast BioLab brought in the right experts to find the solution.
VP, PK PD Analysis

NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.

Small, Large or Novel Modality? We Pick the Platform.

Share the modality and matrix. We'll design it.

Why Do Sponsors Route Whole Programs Through One Bioanalytical Lab?

Our 20+ years of regulated bioanalysis run from small molecule to cell therapy, and scientists rather than a sales sheet make the routing call.

What You Receive

A routed program map: endpoints, platforms, tier and logistics named before you commit
One accession feeding every endpoint family, aliquoted in house on one custody chain
Data packages reconciled across platforms under one Watson LIMS record and one report
A quote that names the tier per endpoint, so nothing is billed above what it defends

What We Need From You

The molecule and what is known about it, modality, matrix and species in plain terms
The decision each endpoint feeds, because that sets the tier honestly per endpoint
Your stage and dates, discovery through pivotal, so routing lands on your calendar
Prior methods or data if any exist, since transfer-in beats rebuild whenever it can

Basics Of Bioanalysis | NorthEast BioLab

The Basics of Bioanalysis: How Do We Develop and Validate Your Bioanalytical Method?

Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites as well as various pharmacodynamics biomarkers in biological fluids….

Bioanalytical CRO Video Read More

One Bispecific Antibody Through The Building: A Representative Routing

The program spans four endpoint families and four platforms, with one custody chain and one point of contact. A two-armed molecule is a demanding test of that map.

Why Do Program Heads Consolidate Their Bioanalysis With Us?

Because your whole program answers to one scientific lead and one quality system, whatever the molecule.

Get Your Bioanalysis Plan Reviewed By PhD Scientists.

Send your plan. We'll flag pitfalls before they cost you.

Every platform a modality can need under one roof, one QAU and one set of 85+ SOPs
US based analysis and storage, so your molecule and samples never leave the country
700+ sponsor studies with a near even small and large molecule split this very year
About 70% of our work is emerging biotech, so routing advice comes from scientists

Regulated And Inspected By: