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.

 

Download the product flyer

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

Example of the Specification Sheet 

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

Clinical-Grade MHC Monomers (GMP) 

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

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 at customer@immudex.com 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

1.760

2.035

150 tests

3.520

4.070