History & Milestones
BIOMEX
History & Milestones.
This is our DNA.
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. Since the day of the foundation, BIOMEX DNA has been growing, with each piece of history we become better.
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 include tissue, PBMC`s and cfDNA to serve the LifeScience industry.
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.
"Every cornerstone of our growth, every person, every spark of a brilliant idea, has made BIOMEX what it is today."
Oliver Bošnjak | General Manager
Our History. Our DNA.
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 include tissue, PBMC`s and cfDNA to serve the LifeScience industry.
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.
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 ESfEQA GmbH
- 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
BIMEX in Short
MORE THAN
Founding of BIOMEX headquartered in Mannheim.
2004 – Oliver Bošnjak, who has degrees in chemistry and business administration, becomes managing partner of BIOMEX.
Certification of BIOMEX according to DIN EN ISO 9001:2000.
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.
Expansion of the Plasma Center for the production of specific normal plasma with a production capacity of 25,000 liters p.a.
Move to one of our own buildings of 1200 m² and set up of a company laboratory. Employment of 30 staff.
Opening of the Heidelberg Plasma Center to expand the donation capacity of plasmas for diagnostic purposes.
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.
Establishment of a mobile donation center, for the collection of patient samples, in West Africa.
Expansion of the laboratory surface area to 230 m².
Implementation of contract studies for the approval of IVD products (list A, B and others). Start of sales in China by sales partners.
New in the portfolio: Prospective clinical sampling according to ICH guidelines.
Acquisition of an operating license for an L3 ** laboratory compliant with DIN 58956-3 and establishment of a worldwide network of distributors.
Start of the online Sampleshop with real-time access to the entire sample inventory of BIOMEX, sample reservation and automatic offer generation.
We opened our Chinese subsidiary Neckar Biotechnology in Shanghai .
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.
The year of Covid.
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.
Expansion, Management & SARS Cov2 antigen tests.
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.
We grow: Acquisition of Atreide Biosamples – Corona rapid test validation – Opening of the Chinese subsidiary – Join our Journey – Expansion of the product portfolio
BIOMEX successfully completes the 155th SARSCov2 Corona rapid test validation 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 include tissue, PBMC`s and cfDNA to serve the LifeScience industry.
