Immunogenicity Services from ProImmune

understand the mechanisms that can lead to immunogenicity risk
through focussed experimental investigation

 
Unwanted immunogenicity to biotherapeutics is a complex and multifactorial challenge. When developing any protein product, it is a potential problem that must be addressed. Unwanted immune responses that target your drug can lead to neutralization and subsequent therapy failure, or worse-still are cross-reactive to essential endogenous proteins, leading to fatal consequences.

Detailed characterization of your product and understanding the level of risk of immunogenicity is not a simple process. You need to deploy the best science, the most rigorous assays and the broadest experience to make the right choices.

We work with clients who are at a range of developmental stages. Our tools are deployed by some as part of their Lead Selection strategy, whereas others may have a final product and want to compare it to a competitor product against the same target or biosimilar. Some clients perform these assays as a routine element of their bioanalysis repertoire during product development; others may need answers to address specific questions that regulatory authorities have posed. ProImmune provides a suite of services for understanding immune responses that can be used together as part of your immunogenicity risk management programme, or as stand-alone assays.
 

We are the world’s leading independent immunogenicity services provider

Over the past two decades ProImmune has established a proven track record in working with every type of client organization, across all major disease areas and with all significant classes of test entity.
 

Summary of Actual Experience at ProImmune

Customer Type
Disease Area
Test Article
Program Stage

Large pharma

Virtual, small, medium and large biotech

Universities

Government institutes

FDA

National health institutes

Military

Consumer products

Crop science

Oncology

Neurology

Hematology

Rheumatology

Autoimmunity

Diabetes

Allergy

Infectious diseases

Transplantation

Rare diseases

Eye disease

Cardiology

Antibody therapeutics

Bi-/multi-specific antibodies

Antibody-drug conjugates

Biosimilars

Novel protein scaffolds

RNA and DNA therapies

Vaccines

Food and crop proteins

Enzyme replacement therapies

Blood factor proteins

Peptide therapeutics

Viral gene therapies

Oncolytic viruses

Viral vector vaccines

CAR-T

Assessment of novel delivery systems:

Nanoparticles

Liposomes

Exosomes

Small molecules

Discovery:

Reverse immunology

Antigenicity profiling

Deimmunization

Validation of rational design

Lead selection

IND

Clinical trial evaluation through phase III

Manufacturing / CMC

Formulation

Many of our customer’s studies have been published or presented at conferences including our own Mastering Immunity Conference Series.

Our assay suite covers all main elements of adaptive and innate immune responses, with specialist assays available to deconvolute the involvement of T cells, B cells and antigen presenting cells. Depending on the project requirement our assay services can be deployed alone or in combination depending on the specific project needs.
 

What it’s like to work with ProImmune

  • Discuss your project requirements with our highly trained Immunology Sales Specialists
  • We ensure that the project scope is fully defined at the outset which is reflected in our quotation
  • Wherever possible we always quote on a fixed fee basis for our work so the client knows from the outset what the project cost will be
  • Sample reports are available for all standard assay service types so you know exactly how we will report data to you

Please navigate through the product and services offering menu from our homepage to explore our products and services in detail.
 

Further reading in relation to the regulatory landscape around preclinical immunogenicity risk assessment

Join the ‘Mastering Immunogenicity’ LinkedIn Group for topical discussions and updates.

Join our Mastering Immunogenicity LinkedIn Group