Biomex GmbH
Biomex is one of Europe’s largest human biospecimen providers to the IvD and pharmaceutical industries. Heidelberg-based Biomex GmbH has been a reliable partner for the diagnostics industry worldwide for over 30 years. Our focus is on the supply of human plasma, negative or positive, also in larger quantities, as well as on the supply of individual patient samples.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Clinical Services
- Market Focus:
- Globally (various continents)
- Year Founded:
- 1989
This company also provides solutions for other industrial applications.
Please, visit the following links for more info:
About Us
Our goal: To solve the procurement problems of our customers
For our customers we solve problems that go far beyond the mere delivery of products. We procure clinical samples worldwide, such as Dengue & Chikungunya samples from freshly infected people in Africa, all HIV subtypes or follow-up samples from Lyme patients.
Unique infrastructure
Over 90% of the plasma is drawn by ourselves at our plasma donation centers in Heidelberg and München. As a customer, you have online, real-time access to our entire sample inventory, consisting of over 450,000 blood and plasma samples and more than 50,000 FFPE tissue blocks.
Quality services
In addition, we offer a wide range of services such as the complete execution of CTS testing of List A products including the creation of test protocols and reports, the investigation of stability data, the production of Lot Release Panels and much more.
Since 2019 Biomex GmbH holds a special license to export Disease State Plasma and patient samples to China.
Quality
Our actions are determined by legal and regulatory requirements and the experience gained from three decades of active business in the diagnostic industry. Our motivation is to provide customers with the best possible service and superior product quality. We are constantly working to improve processes and optimize our service quality. Our quality management system is regularly checked and confirmed by internal and external audits.
We are certified according to DIN EN ISO 9001.
You can download the current certificate here (click on PDF icon):
Certificate DIN EN ISO 9001
Our quality standards at a glance:
- DIN EN ISO 9001
- L3** Laboratory according to DIN 58956-3
- Plasma center meets the guidelines of the German Medical Association
- Positive Vote of the Ethics Committee of the Bavarian Regional Council
- Cooperation with the Paul Ehrlich Institute
- Close cooperation with physicians and clinics as well as national reference laboratories
- Establishment of a plasma donation area according to FDA standards