Excellence in Manufacturing and Beyond

Responsibility for manufacturing clinical-grade reagents does not end upon shipment

Immudex® stands behind every reagent produced with rigorous quality control and procedures for every step of the manufacturing process included within our Quality Management System (QMS).

Ensuring high-quality in production, prior to release, and during use

The manufacturing of our Clinical-Grade Dextramer® reagents is validated according to GMP, demonstrating a track record of robust manufacturing. Having an established shelf life, the products are also provided with an expiry date.

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MANUFACTURING

In accordance with
ISO 13485 and 21 CFR 820

IN-PROCESS QUALITY CONTROL

Starting materials’ performance
MHC-peptide integrity
Biotinylation degree

FINAL QUALITY CONTROL

MHC Dextramer® integrity

PRODUCT RELEASE

Labeling review 
Batch record review 
Certificate of Analysis 
Expiry date

Quality that Meets Authoritative Standards and Requirements

Immudex Clinical-Grade Dextramer® (GMP) reagents meet numerous requirements in accordance with quality system requirements for medical devices defined by ISO 13485 and 21 CFR 820 to be used as:

Components for laboratory-developed tests (LTD)
Reagents for medical devices governed by the Clinical Laboratory Improvement Amendments (CLIA), the US Food & Drug Administration (FDA), and the EU In Vitro Diagnostic Directive (IVDD)
Tools for clinical investigations in accordance with good clinical (laboratory) practice (GC(L)P) and in compliance with ethical principles of medical research involving human subjects as set forth by the Declaration of Helsinki
Materials in manufacturing and quality control of investigational and commercial pharmaceutical products in compliance with good manufacturing practices (GMP)

Learn more about Immudex’s Quality

Why Choose Clinical-Grade MHC Dextramer® (GMP)

Immudex® commits to keep you updated in the event of any changes affecting the product and offers the option to perform a site audit.

We recommend Clinical-Grade Dextramer® (GMP) reagents to comply with regulatory requirements and in long projects that involve several research sites:

Clinical trials
Manufacturing or quality control of investigational or commercial pharmaceutical products
GMP manufacturing of cell-based immunotherapeutics
Monitoring antigen-specific T cells in patients following a therapeutic intervention

Example of the Certificate of Analysis

An example of the Certificate of Analysis provided with Clinical-Grade Dextramer® (GMP) reagents

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Example of the Specification Sheet 

See an example of the ‘spec sheet’ provided with Clinical-Grade Dextramer® (GMP) reagents

Download

Clinical-Grade MHC Monomers (GMP) 

Immudex® also offers MHC Monomers as GMP. Discover our Clinical-Grade MHC Monomers (GMP) offering

Clinical-Grade MHC Monomers (GMP)

Order Clinical-Grade Dextramer® Reagents

Find a broad selection of already available Clinical-Grade Dextramer® reagents in the table below.
If you are interested in other specifications, please contact us to process your request.
You can find a list of our current available MHC alleles.

To order your off-the-shelf Clinical-Grade Dextramer® reagent, please send an email to ordering@immudex.com specifying:

Cat. no
Test size (50, 150 tests)

Immudex has updated the catalog numbers. To learn more about it, please consult the document here

Cat. No.	Allele	Peptide
WB03247G	HLA-A*0201	SLLMWITQV
WB04198G	HLA-A*0201	KVLEHVVRV
WB02696G	HLA-A*0201	SLLMWITQC
WB03578G	HLA-A*0201	GVYDGREHTV
WB03723G	HLA-A*0201	FMNKFIYEI
WB03474G	HLA-A*0201	KVLEYVIKV
WB03246G	HLA-A*0201	GLYDGMEHL
WB04074G	HLA-A*0201	SLLQHLIGL
WB02162G	HLA-A*0201	ELAGIGILTV
WB03429G	HLA-A*0201	WLSLLVPFV
WB04315G	HLA-A*0201	RMSAPSTGGV
WB04313G	HLA-A*0201	FLLDGSANV
WB03823G	HLA-A*0201	YMLDLQPET
WB02666G	HLA-A*0201	Neg. Control
WA02131G	HLA-A*0101	VTEHDTLLY
WB02132G	HLA-A*0201	NLVPMVATV
WC02197G	HLA-A*0301	KLGGALQAK
WF02133G	HLA-A*2402	QYDPVAALF
WH02135G	HLA-B*0702	RPHERNGFTVL
WH02136G	HLA-B*0702	TPRVTGGGAM
WI02137G	HLA-B*0801	ELRRKMMYM
WK02138G	HLA-B*3501	IPSINVHHY
WI03233G	General	Neg. Control

Test Size	Price (EUR)	Price (USD)
50 tests	1,860	2.135
150 tests	3,720	4.275