APPLICATIONS · DISEASE AREA · VACCINES AND IMMUNOGENICITY

Vaccine and biologic programmes are judged on the immune response they can demonstrate

A vaccine programme has to show how much antibody was raised, whether it neutralises, how long it lasts and how much it varies between people. A biologic programme has to show what the immune system did to the drug. Both come down to antibody measurement that will still stand up when the data is read by someone who was not there.

We run vaccine immunogenicity, anti-drug antibody and neutralising antibody work alongside cytokine endpoints and discovery-scale immune profiling, in one laboratory, with data in two weeks.

Talk to a scientist

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APPLICATIONS · DISEASE AREA · VACCINES AND IMMUNOGENICITY

Vaccine and biologic programmes are judged on the immune response they can demonstrate

A vaccine programme has to show how much antibody was raised, whether it neutralises, how long it lasts and how much it varies between people. A biologic programme has to show what the immune system did to the drug. Both come down to antibody measurement that will still stand up when the data is read by someone who was not there.

We run vaccine immunogenicity, anti-drug antibody and neutralising antibody work alongside cytokine endpoints and discovery-scale immune profiling, in one laboratory, with data in two weeks.

Talk to a scientist

Request a quote

APPLICATIONS · DISEASE AREA · VACCINES AND IMMUNOGENICITY

Vaccine and biologic programmes are judged on the immune response they can demonstrate

A vaccine programme has to show how much antibody was raised, whether it neutralises, how long it lasts and how much it varies between people. A biologic programme has to show what the immune system did to the drug. Both come down to antibody measurement that will still stand up when the data is read by someone who was not there.

We run vaccine immunogenicity, anti-drug antibody and neutralising antibody work alongside cytokine endpoints and discovery-scale immune profiling, in one laboratory, with data in two weeks.

Talk to a scientist

Request a quote

Antibody and cytokine response

measured on the same samples

Antibody and cytokine response

measured on the same samples

Antibody and cytokine response

measured on the same samples

Data in two weeks

Data in two weeks

Data in two weeks

4 platforms in 1 laboratory:

NULISA, Simoa, MSD and Element AVITI sequencing

4 platforms in 1 laboratory:

NULISA, Simoa, MSD and Element AVITI sequencing

4 platforms in 1 laboratory:

NULISA, Simoa, MSD and Element AVITI sequencing

HTA licensed, GCP compliant

HTA licensed, GCP compliant

HTA licensed, GCP compliant

WHY IT MATTERS

Two programmes, one measurement problem

Vaccine development and biologic immunogenicity look like different fields, but they share the same core requirement.

Vaccine programme

Measures a response it wants: titre after dosing, neutralising activity, persistence over time and variation between subjects. That means many timepoints across cohorts and often sites, so the numbers have to be comparable with each other and with published data in the field.

Biologic programme

Both depend on analytical decisions made before samples run, not after. Sensitivity, matrix, cut-point strategy and validation scope are agreed against the regulatory framework your programme reports to – and written down. Immunogenicity data gets expensive when that conversation happens after the first plate.

They share a second need, too.

Antibody measurement tells you how big the response is, but nothing about its character. The cytokine and inflammatory signalling around vaccination or dosing sits at concentrations conventional immunoassays cannot resolve – which is why immune response characterisation and titre work usually end up in the same study design.

They share a second need, too.

Antibody measurement tells you how big the response is, but nothing about its character. The cytokine and inflammatory signalling around vaccination or dosing sits at concentrations conventional immunoassays cannot resolve – which is why immune response characterisation and titre work usually end up in the same study design.

They share a second need, too.

Antibody measurement tells you how big the response is, but nothing about its character. The cytokine and inflammatory signalling around vaccination or dosing sits at concentrations conventional immunoassays cannot resolve – which is why immune response characterisation and titre work usually end up in the same study design.

what we measure

What we measure for vaccine and immunogenicity programmes

Vaccine-induced antibody response

Anti-drug antibody and neutralising antibody

Immune response characterisation

Low-abundance and early response markers

Transcriptomic response signatures

Assays that do not exist yet

Talk to a scientist

Where we fit

A single immunogenicity programme can need three things at once: a defensible antibody endpoint, the immune context around it, and the sensitivity to catch early signals the endpoint assay would miss. We run all three here.

The titre or ADA endpoint and the immune response characterisation come from the same aliquot set, in one laboratory, under one chain of custody. So when the immune profile and the antibody result disagree – and sometimes they do – you are looking at biology, not at differences between two suppliers.

It also means the study can change shape without changing supplier.

Broad NULISA profiling identifies the immune signals that separate high responders from low. The markers carrying that signal then move onto MSD or Simoa for validated or ultra-sensitive measurement, with the antibody endpoint running alongside both.

Assay design, cut-point strategy and validation scope are agreed against the regulatory framework your programme reports to. We work to GCP-compliant workflows under HTA licence 12818 and are aligned to ISO 15189, with accreditation in progress. All work described on this page is for research use only.

Talk to a scientist about your programme

Where we fit

A single immunogenicity programme can need three things at once: a defensible antibody endpoint, the immune context around it, and the sensitivity to catch early signals the endpoint assay would miss. We run all three here.

The titre or ADA endpoint and the immune response characterisation come from the same aliquot set, in one laboratory, under one chain of custody. So when the immune profile and the antibody result disagree – and sometimes they do – you are looking at biology, not at differences between two suppliers.

It also means the study can change shape without changing supplier.

Broad NULISA profiling identifies the immune signals that separate high responders from low. The markers carrying that signal then move onto MSD or Simoa for validated or ultra-sensitive measurement, with the antibody endpoint running alongside both.

Assay design, cut-point strategy and validation scope are agreed against the regulatory framework your programme reports to. We work to GCP-compliant workflows under HTA licence 12818 and are aligned to ISO 15189, with accreditation in progress. All work described on this page is for research use only.

Talk to a scientist

Where we fit

A single immunogenicity programme can need three things at once: a defensible antibody endpoint, the immune context around it, and the sensitivity to catch early signals the endpoint assay would miss. We run all three here.

The titre or ADA endpoint and the immune response characterisation come from the same aliquot set, in one laboratory, under one chain of custody. So when the immune profile and the antibody result disagree – and sometimes they do – you are looking at biology, not at differences between two suppliers.

It also means the study can change shape without changing supplier.

Broad NULISA profiling identifies the immune signals that separate high responders from low. The markers carrying that signal then move onto MSD or Simoa for validated or ultra-sensitive measurement, with the antibody endpoint running alongside both.

Assay design, cut-point strategy and validation scope are agreed against the regulatory framework your programme reports to. We work to GCP-compliant workflows under HTA licence 12818 and are aligned to ISO 15189, with accreditation in progress. All work described on this page is for research use only.

Talk to a scientist about your programme

Typical applications

Vaccine development

Immunogenicity of biologics

Immune response characterisation

Correlates of protection

  • Preclinical and clinical vaccine development

  • Antibody titre and neutralising activity after dosing

  • Persistence of response across a longitudinal time course

Vaccine development

Immunogenicity of biologics

Immune response characterisation

Correlates of protection

  • Preclinical and clinical vaccine development

  • Antibody titre and neutralising activity after dosing

  • Persistence of response across a longitudinal time course

Tell us what you need to measure

Tell us the antigen or the therapeutic, the matrix, your timepoints and your cohort size, and the regulatory framework your programme reports to. We will tell you which platform covers the work, what sensitivity you can expect, what validation scope the study needs, and whether an assay has to be built.

That reply comes within one working day.

Send us your requirement

Vaccines and Immunogenicity

When the assay has to be built first

A proprietary biologic has no off-the-shelf ADA assay. A novel antigen has no off-the-shelf titre assay. In both cases the assay is part of the programme, and it has to be built to a specification that survives review: sensitivity, drug tolerance, cut-point, and a validation scope matched to the framework the study reports to.

That work is the Custom assay development capability, and it is where most immunogenicity programmes with a new molecule start. We are one of only five laboratories worldwide certified by Alamar for NULISA custom assay development, and the only one in the UK. We develop on Simoa Homebrew and MSD U-PLEX as well, so the format follows the requirement.

Conceptual feasibility costs nothing. Send us the target and the intended use and we will tell you whether a catalogue assay already covers it, which is sometimes the answer, before anyone quotes development.

More about Custom assay development

Talk to us about a decentralised design

The practical detail

Turnaround

Two weeks from sample receipt, confirmed in writing at quote

Quote

Within one working day of receiving your requirement

Up to 1,000-fold greater than conventional ELISA.

Femtogram-per-millilitre for many targets.

SR-X performance figures confirmed per assay at scoping

Sample confirmation

Receipt and condition confirmed within two working days, before anything is consumed

Receipt and condition confirmed within two working days, before anything is consumed

Sample volume

NULISAseq needs 25 µL of sample and NULISAqpcr needs 35 µL. Ship about 10 µL more than the assay requires, so 35 µL for NULISAseq and 45 µL for NULISAqpcr, which covers dead volume and leaves enough for a repeat. MSD and Simoa requirements are assay-dependent

NULISAseq needs 25 µL of sample and NULISAqpcr needs 35 µL. Ship about 10 µL more than the assay requires, so 35 µL for NULISAseq and 45 µL for NULISAqpcr, which covers dead volume and leaves enough for a repeat. MSD and Simoa requirements are assay-dependent

Matrices

Plasma, serum, CSF, urine, cell-culture supernatant and tissue lysate. Specialist matrices including BAL, sputum, nasal lining fluid, EBC and interstitial fluid scoped for feasibility

Plasma, serum, CSF, urine, cell-culture supernatant and tissue lysate. Specialist matrices including BAL, sputum, nasal lining fluid, EBC and interstitial fluid scoped for feasibility

Cohort size

Dozens to tens of thousands of samples

Dozens to tens of thousands of samples

Data output

Relative quantification in NPQ units for NULISAseq panels. Absolute concentrations in pg/mL for MSD, Simoa and the 250 AQ panel

Relative quantification in NPQ units for NULISAseq panels. Absolute concentrations in pg/mL for MSD, Simoa and the 250 AQ panel

Assay design and validation

Design, cut-point strategy and validation scope agreed upfront against the regulatory framework your programme reports to

Design, cut-point strategy and validation scope agreed upfront against the regulatory framework your programme reports to

Deliverables

Normalised concentrations, QC metrics and run documentation as standard. Statistical analysis is not included as standard. Bioinformatic analysis is available and scoped separately

Normalised concentrations, QC metrics and run documentation as standard. Statistical analysis is not included as standard. Bioinformatic analysis is available and scoped separately

Quality framework

HTA licence 12818. GCP-compliant workflows. Aligned to ISO 15189, with accreditation in progress

HTA licence 12818. GCP-compliant workflows. Aligned to ISO 15189, with accreditation in progress

Regulatory status

For research use only. Not for use in diagnostic procedures

Regulatory status

For research use only. Not for use in diagnostic procedures

For research use only. Not for use in diagnostic procedures

The right platform for every antibody question

ADA and neutralising antibody work runs on MSD, the platform with the deepest regulatory acceptance for it, with design and validation scope agreed against your framework in writing.


Where the assay has to be built, we hold one of five worldwide Alamar certifications for NULISA custom assay development. And the immune response around the antibody endpoint can be characterised to approximately 340 proteins from the same small-volume sample.

We run Simoa on the SR-X alongside NULISA, MSD and sequencing.

All of them are ours, so the recommendation you get is a scientific one. If your target is better served by NULISA or MSD we will say so, and the work stays with us either way.



Homebrew development means we are not limited to the catalogue.


Where no commercial Simoa assay exists for your target, we can build one.

THE ALTHEOME DIFFERENCE

Why infection programmes work with us

The endpoint and the immune context in one place

Assays built where none exist

Design decisions made before the first plate

Time course designs handled as designs

Speed as a design principle

Senior scientific oversight

Analysis by the people who ran the assay

Quality framework

Antibody measurement, validated cytokine endpoints, discovery-scale immune profiling, femtogram-level single-marker assays and RNA sequencing, on one sample set.

Talk to a scientist

THE ALTHEOME DIFFERENCE

Why infection programmes work with us

The endpoint and the immune context in one place

Assays built where none exist

Design decisions made before the first plate

Time course designs handled as designs

Speed as a design principle

Senior scientific oversight

Analysis by the people who ran the assay

Quality framework

Antibody measurement, validated cytokine endpoints, discovery-scale immune profiling, femtogram-level single-marker assays and RNA sequencing, on one sample set.

Talk to a scientist

THE ALTHEOME DIFFERENCE

Why infection programmes work with us

The endpoint and the immune context in one place

Assays built where none exist

Design decisions made before the first plate

Time course designs handled as designs

Speed as a design principle

Senior scientific oversight

Analysis by the people who ran the assay

Quality framework

Antibody measurement, validated cytokine endpoints, discovery-scale immune profiling, femtogram-level single-marker assays and RNA sequencing, on one sample set.

Talk to a scientist

Tell us about your study

Send us the antigen or the therapeutic, your matrix, your timepoints and your cohort size. A senior scientist will tell you which platform fits, what the validation scope should be, and whether an assay needs building.

Talk to a scientist

Request a quote

You will hear from us within one working day.

You will hear from us within one working day.

Related plataforms
Related capabilities
Related matrices
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Still curious? Find answers in our FAQ's.

FAQ page

Related plataforms
Related capabilities
Related matrices
Related research areas
Related disease areas

Still curious? Find answers in our FAQ's.

FAQ page