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
Check out our presentation for Diagnostics & Life Sciences
MORE THAN
„Every brilliant experiment, like every great work of art, starts with an act of imagination.“
History
2022
We grow: Acquisition of Atreide Biosamples, a recognized specialist in the sourcing of tumorous tissue samples for the life science industry.
BIOMEX successfully completes the 155th SARSCov2 Corona rapid test validation, becoming the company with the highest number of Corona assay validations.
Opening of the Chinese subsidiary – Neckar Biotechnology – in Shanghai.
Launch of the new campaign “Join our Journey”, which communicates the progress of BIOMEX in the new segments.
Expansion of the product portfolio to better serve the Life Science industry. From FFPE tissue blocks to PBMCs and cfDNA, BIOMEX now offers a comprehensive range of resources for research and studies.
2021
Further expansion of laboratory capacities: in order to be able to handle the constantly high demand from the diagnostic industry, BIOMEX continues to expand the laboratory area.
Establishment as the largest validation provider of SARS Cov2 antigen tests and rapid tests with over 70 validation studies completed.
Strengthening of the management team by Dr. Klaus Esperschidt, who is responsible for the Operations division as Managing Director.
2020 – The year of COVID
As the first supplier worldwide: Acquisition of large amounts of plasma from recovered covid patients (over 3000 plasma units) and provision to the IVD industry for the production of antibody tests.
Collection of over 8000 smears from SARS-Covid-positive individuals at the beginning of the second covid wave. Establishment as the largest validation provider for coronavirus antigen tests and coronavirus antigen rapid tests.
Establishment of a fully functional L2 laboratory to process up to 3,000 PCR tests per day.
Recertification according to DIN EN ISO 9001:2015.
2015 – 2019
2019 – Expansion of laboratory capacity to 600 m2. Establishment of the company’s own, sealed rooms for external companies to carry out contract studies. Implementation of prospective clinical sampling in accordance with DIN EN ISO14155: 2020.
2018 – Start of the online Sampleshop with real-time access to the entire sample inventory of BIOMEX, sample reservation and automatic offer generation.
2017 – Acquisition of an operating license for an L3 ** laboratory compliant with DIN 58956-3 and establishment of a worldwide network of distributors.
2016 – Expansion of the product portfolio to include panels from the company ZeptoMetrix.
2015 – New in the portfolio: Prospective clinical sampling according to ICH guidelines.
2010 – 2014
2014 – Implementation of contract studies for the approval of IVD products (list A, B and others). Start of sales in China by sales partners.
2013 – Founding of the sister company ESfEQA GmbH as an accredited provider of external round robin tests.
2012 – Expansion of the laboratory surface area to 230 m².
2011 – Establishment of a mobile donation center, for the collection of patient samples, in West Africa. Certification of BIOMEX according to DIN EN ISO 13485:2003. Founding of the sister company DiaMex GmbH as a supplier of manufacturer-independent controls.
2010 – Expansion of the laboratory area to 110 m2 and acquisition of an operating license for a microbiological L2 laboratory according to DIN 58956-3. Recertification according to DIN EN ISO 9001:2008.
2004 – 2009
2009 – Opening of the Heidelberg Plasma Center to expand the donation capacity of plasmas for diagnostic purposes.
2008 – Move to one of our own buildings of 1200 m² and set up of a company laboratory. Employment of 30 staff.
2007 – Expansion of the Plasma Center for the production of specific normal plasma with a production capacity of 25,000 liters p.a.
2006 – Founding of the Plasma Center in Munich and certification according to ISO 9001:2000. The main focus of the Plasma Center in Munich is the production of disease state plasma for diagnostic purposes.
2005 – Certification of BIOMEX according to DIN EN ISO 9001:2000.
2004 – Oliver Bošnjak, who has degrees in chemistry and business administration, becomes managing partner of BIOMEX.
1989
Founding of BIOMEX headquartered in Mannheim.
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:
Current milestones of our quality management
2022
- 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 Abbott Diagnostics Korea Inc.
- Expansion of laboratory capacities
2021
- 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.
2020
- 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”
2019
- 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”
2018
- 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”
2017
- 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”
2016
- 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
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.
