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SUPPORTING THERAPEUTIC DRUG MONITORING OF MONOCLONAL ANTIBODIES BY MASS SPECTROMETRY 

Promise Proteomics has developed the mAbXmise® range of products for monitoring both therapeutic monoclonal antibodies (t-mAbs) concentrations and corresponding Anti-Drug Antibodies (ADAs) levels using Mass Spectrometry (MS). The proteotypic peptides, i.e. signature peptides, issued from trypsin digestion of the t-mAbs and their labelled forms (internal standards) are measured by LC-MS.

Promise focalizes its Expertise in tdm

Promise Proteomics is a French provider of quantification solutions for t-mAbs and ADAs and innovates by using the analytical performance of MS to support their quantitative monitoring.

* Analytical precision is evaluated in accordance with the requirements and recommendations of CLSI standards, in particular EP05, which relates to the evaluation of measurement procedure precision.

** Trueness and reliability of quantification are supported by the evaluation of mAbXmise kits metrological traceability in accordance with the requirements of ISO 17511, ensuring appropriate traceability of measurement results to recognized references.

 

The analytical performance mentioned above are reported in the corresponding Instructions for Use (IFU). The IFUs are available in the Customer Area. Please reach us for any question regarding the analytical performance.

Our Range of mabxmise kits

mAbXmise® is a range of products based on MS and incorporating Stable-Isotopically Labelled (SIL) t-mAbs as internal standards. mAbXmise kits are designed to perform Liquid Chromatography coupled with Mass Spectrometry (LC-MS) quantification of specific t-mAbs.

Our range of
diagnostic kits

mAbXmise is a unique commercial ready-to-use kit approach, based on mass spectrometry, including stable-labelled mAbs as Internal Standards, and CE-IVD. The solution is designed to monitor the concentration of therapeutic mAbs in samples from patients treated with these mAbs. The kit enables quantitative analysis to be performed on plasma and serum. The kit is an in vitro diagnostic medical device intended for professional laboratory use. The results of the analysis are intended for use by healthcare professionals.

There are numerous benefits to using mAbXmise kit technology:

  • Drug monitoring helps reduce the chance of toxicity: Overexposure can be anticipated by monitoring drug concentration in blood[2]

  • This multiplex LC-MS/MS method outperforms other methods for patient receiving combination therapies (or treated conjointly with 2 monoclonal antibodies), saving time and money[3]

  • Mass spectrometry produces an analytical robustness compared to immunoassays[4]

 

Contact us

 

OUR EASY TO USE KITS

Our mAbXmise kits are complete read-to-use solutions for facilitating the quantification of monoclonal antibodies using mass spectrometry in the laboratory.

SIL-mAbs are incorporated in our mAbXmise kits for ensuring quantification performances.

The solution provided enables to perform the pre-analytical steps before LC-MS analysis, and is compatible with most of the LC-MS configurations and brands.

To ensure a satisfaying experience, technical support is provided and our application team wil be at your side during the implementation phase.

INCLUDED IN EACH KIT :

-96 well plate coated with stable labelled mAbs (internal standards)

-6 Calibrators

-2 Quality Controls

-Suited buffers and solutions

-Specific consumables

-Protease

Our PRODUCTS

The range developed by Promise Proteomics includes 13 products.

3 kits are CE-IVDD*, 4 kits are CE-IVDR** and 6 kits are still in the pipeline to obtain CE-IVDR marking. Meanwhile, they can be already used as Research Use Only products.

 

DISCOVER OUR MABXMISE SALES CATALOGCONSULT OUR SAFETY DATASHEETS

Our technology step-by-step

Key assets

From the patient’s blood sample to the monitoring of therapeutic antibodies,
mAbXmise diagnostic kits are:

EASY-TO-USE

sample preparation with mAbXmise labelled

internal standards added to blood sample

MULTIPLEX

quantitative analysis

using mass spectrometry,

measuring simultaneously

several therapeutic mAbs

ACCURATE

measurement of therapeutic mAbs

with 100% accuracy and

specificity according to

the peptide signature

CONTACT US

“Current treatment regimens are still either single-dose or calculated on the basis of patient weight, whereas there is increasing evidence of inter-patient variability due to several factors such as age, gender, pathological state and others.

With mAbXmise, we hope we can facilitate the adoption of this practice in the hospital, to allow individualized medicine by personalizing the frequency of administration, compensate for inter-individual variability and reducing treatment costs.”[3]

Dorothée LEBERT, Chief Scientific Officer, Promise Proteomics

mAbXmise monoclonal antibodies quantification kits are In Vitro Diagnostic Medical Devices for laboratory professional use and CE-IVD labeled for Europe by BSI. Assay results are intended to be used by healthcare professionals. The kits are designed to perform absolute quantification by LC-MS (Liquid Chromatography – Mass spectrometry) of specific therapeutic monoclonal antibodies (mAbs) in a patient sample. Assay results are intended to be used by healthcare professionals. Before use, it is important to carefully read the instructions provided with the product. The products are non-refundable. The mAbXmise Kit described has not been cleared by any regulatory entity for diagnostic purposes outside of Europe. Proteomics mAbXmise Kits are not available for sale in all countries.

Our company

Promise Proteomics was created in 2010 as a spin-off of CEA Grenoble (France). This medtech company is currently wholly owned by the Aguettant group.

 

Since 2013, Chief Scientific Officer of Promise, Dorothee Lebert, has led ambitious and collaborative R&D programs which have allowed to develop the technology, on which the diagnostic kits for personalized medical applications are based.

 

Capitalizing on its unique know-how in the production of internal standards for protein assays and its recognized expertise in mass spectrometry-based quantification methods, Promise Proteomics is placing its skills at the service of healthcare professionals through its mAbXmise kits.

Importantly, we are an integrated research & diagnostics company, meaning that we have the capabilities and experience to manage innovation, development or research & IVD products, manufacturing and market access.

Currently, the company holds 2 ISO certifications: ISO9001 and ISO13485, its QMS is CE-IVDR certified.

mAbXmise range counts already 3 CE-IVDD and 4 CE-IVDR products.

 

Lean more about Promise Proteomics

 

10

clinical articles published citing mAbXmise kits

10

clinical articles published citing mAbXmise kits

> 20

clinical reseach studies ongoing in Europe using our kits

> 20

clinical reseach studies ongoing in Europe using our kits

4

patents

4

patents

11

multiplex kits
available

11

multiplex kits
available

39

mAbs available in our solutions (kits and SIL-mAbs)

39

mAbs available in our solutions (kits and SIL-mAbs)

7

therapeutic areas

7

therapeutic areas

Our references & awards

KEY REFERENCES

Discover our references in our Resource Library

AWARDS

>Awardee of the Proof-of-concept program for ambitious R&D programs in public-private partnership, addressing a medical need in Oncology (2017)

> Semifinalist of AACC’s disruptive technology award session rewarding the next innovative testing solution that will transform patient care (2018)

 

The related patents numbers are :

US11543416, US11053303, US11630111, EP3165928, EP3165922, EP3457139 and EP4231017

[1] Puszkiel, A.; et al. Extending the dosing intervals of nivolumab: model-based simulations in unselected cancer patients. (2024). British Journal Of Cancer, 130(11), 1866‑1874. https://doi.org/10.1038/s41416-024-02659-x

[2] Broué, F. Advantages of monitoring biotherapies in oncology. La Lettre du Cancérologue, 90-91. 2022

[3] Marin, C.; et al. Cross-Validation of a Multiplex LC-MS/MS Method for Assaying mAbs Plasma Levels in Patients with Cancer: A GPCO-UNICANCER

Study. Pharmaceuticals 2021, 14, 796. https://doi.org/10.3390/ph14080796

[4] Millet A, Khoudour N, Guitton J, Lebert D, Goldwasser F, Blanchet B, Machon C. Analysis of Pembrolizumab in Human Plasma by LCMS/HRMS.  Method Validation and Comparison with Elisa. Biomedicines. 2021 May 30

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    Promise Proteomics

    7, parvis Louis Néel • BHT 52 A • CS 20050

    38040 Grenoble Cedex 9 • FRANCE

    PHONE: +33 4 38 02 36 50

    promise-proteomics.com

     

    Last update: September, 2024 – Internal code: PROM-0023.V01-09.24

     

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