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BIOMEX:
Europe’s Leading Provider for Human Biospecimens for the Diagnostics and Life Sciences Industries

What sets us apart?

Our consistent and dependable supply of both positive and negative plasma has established us as a valued partner in the diagnostic industry for many years. Our reputation for finding solutions to even the most challenging requests has been well-established.

Key to your success!

We offer the best of both worlds: the stability and expertise of a larger organization combined with the agility and adaptability of a smaller one. Our professional infrastructure and proven processes are matched by our willingness to take on new challenges.

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BIMEX in Short

Our mission: To solve the sourcing problem for our customers
We solve problems for our customers that go far beyond the pure supply of products. We procure clinical samples worldwide, such as chikungunya samples from freshly infected people in Africa, all the HIV subtypes and also progressive samples from Lyme disease patients.
Unique infrastructure
We sample over 90% of the plasmas ourselves in our plasma centers in Heidelberg and Munich, as well as in our mobile donation center in Cameroon (Africa). As a customer, you have real-time online access to our entire sample inventory via our SampleShop, consisting of over 600,000 blood and plasma samples, as well as more than 50,000 FFPE tissue blocks.
Quality services
In addition, we also offer a wide range of services including the complete implementation of tests according to CTS / CS for products in List A (IVDD) or Class D and C (IVDR), the creation of test protocols and reports, the determination of stability data, the manufacture of lot release panels, and much, much more.

Since 2019, BIOMEX has had a special permit to export Disease State Plasma and patient samples to China.
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„Every brilliant experiment, like every great work of art, starts with an act of imagination.“

Our Customers

We have a strong presence in Europe, but we see the development of global markets as a key success factor – for ourselves and for progress in the service of health. Geographically, our focus is on Europe, Asia and North America. For customers based there, we source and supply human samples and conduct studies for the approval of products in Europe in accordance with the IVDR.

For our Chinese customers, we have opened a branch office in Shanghai to provide the best possible local support.

InVitro diagnostics has represented our largest customer segment to date. In 2021, we have expanded our business segment to serve the Life Sciences industry with high quality products and services.

BIOMEX
Milestones

2016

Monitoring audit according to ISO 9001 & ISO 13485. Customer audit by ESfEQA GmbH.

Monitoring audit according to ISO 9001: 2008 by the Notified Body mdc for BIOMEX with the Munich plasma center. Monitoring audit according to ISO 13485: 2012 by the Notified Body mdc for BIOMEX in the field of in vitro diagnostics.
Customer audit by ESfEQA GmbH.
2017

Recertification, Monitoring, WCA & Customer audits.

Recertification audit according to ISO 9001: 2008 by the Notified Body mdc for BIOMEX with the plasma centers in Heidelberg and Munich. Monitoring audit according to ISO 13485: 2012 by the Notified Body mdc for BIOMEX in the field of in vitro diagnostics.
Customer audit by Abbott USA. WCA audit (Workplace Condition Assessment) by Intertec Certification GmbH commissioned by our customer Abbott USA. Customer audit by ESfEQA GmbH in the area of “Cooling equipment”. Customer audit by ESfEQA GmbH in the area of “Production of round robin test samples”.
2018

Monitoring, Surveillance & Customer audits.

Monitoring audit according to DIN EN ISO 9001: 2015 by the Notified Body mdc. Monitoring audit according to DIN EN ISO 13485: 2012 by the Notified Body mdc. Surveillance audit according to EU Directive 98/79/EC by the Notified Body mdc. Customer audit by Roche Diagnostics GmbH in the area of “Plasma for controls/clinical studies”. Customer audit by ESfEQA GmbH in the area of “Production of round robin test samples”.
2019

Monitoring audit according to ISO 9001, Multi-day audit by the Chinese Supreme Customs Authority & Customer audits.

Monitoring audit according to DIN EN ISO 9001: 2015 by the Notified Body mdc, part 1 (divided in two due to the covid pandemic). A multi-day audit by a delegation from the Chinese Supreme Customs Authority with the result: BIOMEX receives an export permit for plasma products to China. Customer audit by Bio-Rad Laboratories GmbHR for qualification as a supplier. Customer audit by Roche Diagnostics GmbH in the area of “Plasma for controls/clinical studies”. Customer audit by ESfEQA GmbH in the area of “Production of round robin test samples”.
2020

Monitoring, Surveillance & Customer audits.

Monitoring audit according to DIN EN ISO 9001: 2015 by the Notified Body mdc, part 2. Customer audit by Abbott (UK). Surveillance audit according to DIN EN ISO 9001:2015 by the notified body mdc. Customer audit by Roche (Switzerland) on the subject of SHE (Safety, Health, Environmental). Customer audit by ESfEQA GmbH in the area of “Monitoring of cooling equipment”.
2021


Start of the accreditation process according to EN ISO/IEC 17025, Monitoring & Customer audits.

Start of the accreditation process according to EN ISO/IEC 17025: 2018. Monitoring audit according to DIN EN ISO 9001: 2015 by the Notified Body mdc. Customer audit by Abbott USA. Customer audit by Fujirebio Diagnostics, Inc.
2022

First audit for accreditation process according to EN ISO/IEC 17025, Surveillance & Customer audits, Expansion of lab capacities.

Customer audit Biokit, a Werfen Group Company. First audit for accreditation procedure according to EN ISO/IEC 17025:2018. Surveillance audit according to DIN EN ISO 9001:2015 by the notified body mdc. Customer audit ESfEQA GmbH. Customer audit Abbott Diagnostics Korea Inc. Expansion of laboratory capacities.

The future is now.

MORE THAN

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PBMC Samples
100000
Remnant Lab Samples
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Characterized FFPE Blocks
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