Company

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.

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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MORE THAN

0
PBMC Samples
100000
Remnant Lab Samples
2000000
Characterized FFPE Blocks

„Every brilliant experiment, like every great work of art, starts with an act of imagination.“

History

Quality and Certification

Our focus is on providing high quality samples that are essential for research. This is why we are certified according to DIN EN ISO 9001: 2015. All of our services are oriented towards the requirements of GCP / GCLP, GDP and GLP.

Our motivation is to offer the best possible service when it comes to flexibly and reliably implementing customer specifications. We follow the principle of continuous improvement – all processes are permanently being monitored and optimized. Our quality management system is regularly checked and confirmed by internal and external audits. 


Nevertheless, we can still look back on more than three decades of active business operations in the diagnostic and life science industry and incorporate this expertise and the know-how gained into all our projects. 

All of our projects comply with the requirements of the ethics committee of the RP Bavaria, while all our actions are also subject to the following regulatory requirements:

  • GCP / GCLP, GDP, GLP

  • L2 and L3** laboratory compliant with DIN 58956-3

  • Clinical testing of medical devices according to DIN EN ISO 14155

  • Clinical & Laboratory Standards Institute Guidelines (CLSI)

  • International Council for Harmonisation Guidelines (ICH)

  • Directive on in vitro diagnostic medical devices (98/79/EC)

  • IVDR Regulation ((EU) 2017/746)

  • Guideline on hemotherapy of the German Medical Association

Current milestones
of our quality management

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.

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