Bioanalytical Method Development Services

Q: How long does method development take?

A feasibility read lands in days, and a typical small molecule LC-MS/MS build completes in two to four weeks. Ligand binding builds follow their reagent timelines, since antibody pair sourcing can outweigh the lab work. Hard analytes take longer, and the feasibility read is where we say so, instead of letting you discover it on an invoice.

Q: What is the difference between development and validation?

Development makes the method exist: extraction, separation, detection and formats chosen, tested and documented. Validation proves it formally against stated acceptance criteria, and it has its own page, its own plan and its own report. Building to those criteria from day one is why our methods treat validation as a step rather than a gamble.

Q: Can you finish a method we started?

Yes. A literature method, a compendial method or your own draft becomes a working method here without starting over. That is different from transferring a validated method between labs, which is its own discipline with its own page. If the file is thin, development quietly fills the gaps and the report says exactly what changed.

Q: What if no reference standard exists yet?

We can source reference and internal standards, or work directly with your chemistry vendor while the build is scoped. For ligand binding methods, calibrator material and critical reagents drive the plan, and we manage lots so the method does not die when a reagent batch does.

Q: Should my molecule run on LC-MS or ligand binding?

Small molecules and most peptides usually run LC-MS/MS; proteins, immunogenicity and many biologics run ligand binding; some programs use both for different questions. The feasibility discussion settles it with data rather than preference, since we run twelve LC-MS systems and the full immunoassay fleet under one roof and have no platform to protect.

Q: Do we own the method?

Yes. The method file and development report are yours, written so any qualified lab could run them. Sponsors stay because more than 90% of methods built here go on to run study samples here, not because anything holds them.

Q: Do you develop biomarker methods too?

Endogenous analytes are their own discipline, where context of use decides the rigor, and they have their own page under Biomarker CRO. This page is the build for drugs and their metabolites. The same benches run both, which is exactly why the boundary is worth keeping clean.

De-Risk Your Method Development, Draft to Validated.

Brief PhDs on your analyte, matrix and target LLOQ.

Extraction, Chromatography And MRM Transitions Engineered Around Your Molecule
Capture And Detection Antibody Pairs, Formats And MRD For Ligand Binding Builds
500+ Custom Methods Built In House, With 90%+ Going On To Run Study Samples Here
Feasibility Read In Days And Small Builds Done In Two To Four Weeks, Documented

Regulated And Inspected By:

What A Method Build At Our Lab Includes

A method is a chain of choices: extraction, separation, detection, and how the run proves itself. Development makes those choices deliberately and targets the criteria validation will grade against.

Small Molecule LC-MS/MS Builds, From Tune To Matrix

Protein precipitation, LLE or SPE chosen against recovery, cleanliness and runtime cost
Column chemistry, gradient and MRM transitions tuned until the peak defends itself

Difficult Analytes: Unstable, Sticky, Interfered

Stabilizers, derivatization and cold-chain sample handling for analytes that fall apart
Nonspecific binding tamed for oligos, metabolite interference chromatographed away

Ligand Binding Builds: Pairs, Format And MRD

Capture and detection pairs screened head to head, sandwich or bridging format chosen
Minimum required dilution, hook effect and calibrator matrix settled before QC runs

Draft Methods Finished, Library Methods Adapted

A literature or sponsor draft becomes a working method here without ever starting over
Adaptations from 500+ in-house methods often reach a feasibility read within days

Sensitivity Engineering Down To The Study LLOQ

When the PK model predicts troughs your current method cannot see, we go get them
AB Sciex 7500 headroom, concentration steps and smarter extraction, traded deliberately

Documented So Validation Is A Step, Not A Redo

Development targets the acceptance criteria validation will grade the method against
The development report hands validation a method with its reasoning already on the record

Where Your Method Starts

You can start from scratch, from our library of 500-plus prior methods, from a kit or from your incumbent's file. Reusing prior work saves weeks before validation begins.

From Scratch

No method exists anywhere: built from first principles around molecule and matrix
From Our 500+ Library

An in-house method adapted to your analyte, weeks saved before validation begins
From A Kit

A commercial kit qualified and hardened for your matrix instead of trusted blind
From Your Incumbent's File

A working method transfers in with bridging, faster and cheaper than rebuilding
Method Transfer
From A Failed Method

A rescue: the failure diagnosed, the chemistry fixed, the history preserved
Method Transfer
Toward Validation

Every start ends at the same door: a development report written for validation
Method Validation

Ready To Start? Scope Your Method Development.

Tailored method development quote in 2 days.

A Method Built Twice Costs Double, So Ours Are Scoped To Pass Once

Development drifts on undefined sensitivity targets and unlimited optimization. The SOW names the LLOQ, the matrix and the finish line.

Talk Science First? Ask Our Method Dev Experts.

Discuss analyte, matrix and target LLOQ.

A feasibility read lands in days and a typical small molecule build completes in two to four weeks, so the method is never the reason a study start or an IND meeting date has to move.
More than 90% of methods developed here go on to run study samples here, which means every build is done with the next two years of your program in mind, not as a deliverable that ships.
Senior scientists carrying 18+ years in the industry run the builds on twelve LC-MS systems plus MSD, Luminex, ELISA, flow and PCR platforms, with duplicate instruments protecting your calendar.

500+Custom Methods Built Here Before Yours Ever Arrives

90%+Of Methods Developed Here Go On To Run Study Samples Here

What Does Method Development Cost?

Builds are quoted per method with the feasibility read priced separately, so you never commit a full budget before data exists. Typical small molecule builds complete in two to four weeks, ligand binding follows reagent timelines, and a senior scientist replies within two business days.

Your Cost Cannot Move Mid-Study

The quote you approve is the price you pay. Scope can only change through an SOW addendum you have already approved, which matters most on development work, where other labs treat every surprise as a change order.

What Sponsors Say About Methods We Built

One in three of the 100+ sponsors we work with every year is in at least a fourth consecutive year, and most of those relationships began with one method that worked.

VP, PK PD Analysis

NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.
VP, Head of Clinical Operations

Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.
Director, PK

We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.
Sr. Dir., Bioanalytical Development & QC

NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms
President & CSO, Biotech

We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data
Executive Director, Pharmacokinetics

We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects

Need a Method Built From Scratch? Any Matrix.

Share the analyte class and LLOQ. Keep your structure.

Why Programs Start Their Method With Us

The build is the cheapest moment to get your program right, and the feasibility read means you never commit a full budget before data exists.

What You Receive

A development report carrying final conditions, performance data and the reasoning
The method file itself, yours to keep, written so validation can grade it cleanly
A feasibility read early enough to change course before the budget is fully committed
An itemized quote naming the tier, the target LLOQ and what the build actually includes

What We Need From You

The molecule: structure or sequence, salt form, and whatever is already known about it
Reference standard and internal standard if you have them; we can also source both
The matrix and species, since a plasma method is not a brain homogenate method yet
The LLOQ the study needs, since sensitivity is what sets the full price of the build

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….

LC-MS Video Read More

A Molecule With No Method: One LC-MS/MS Build, Step By Step

From reference standard in hand to validation-ready, with every choice made in the open: extraction, transitions, gradient, acceptance targets.

1. Standard In Hand

Reference standard logged, stock plan set, internal standard chosen
2. Tune And Transitions

Parent and product ions selected on the AB Sciex fleet, MRM pairs ranked
3. Extraction Chosen

Protein precipitation, LLE and SPE compared on recovery and cleanliness
4. Chromatography Locked

Column, gradient and runtime settled against peak shape and carryover
5. Matrix Challenge

Multiple matrix lots screened, hemolyzed and lipemic where the study needs them
6. Report And Hand-Off

Development report out, validation plan drafted next door

Why Do Sponsors Choose Our Lab To Build A New Method?

Because development ends on purpose, at exit criteria we both signed, with validation already on the calendar.

Get Your Method Plan Reviewed By PhD Scientists.

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

500+ custom methods built in house, so your molecule rarely starts from a blank page
Senior scientists with 18+ years in the industry, the people who actually run your development
More than 90% of methods built here stay here for validation and study sample analysis
Twelve LC-MS systems plus the full immunoassay fleet, duplicated where downtime hurts

Regulated And Inspected By: