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Pharma Quality Control Media Statements

CATTI, Canadian Advanced Therapies Training Institute, and bioMérieux

MEDIA STATEMENT

CATTI and bioMérieux Canada are joining forces to support the development of a qualified workforce in advanced therapies

bioMérieux and NecstGen, collaborate to accelerate the development of Cell and Gene Therapies (CGT) through the provision of ‘state of the art’ and rapid quality and safety testing technologies that will allow safe and effective advanced therapeutics production.

CATTI, Canadian Advanced Therapies Training Institute, and bioMérieux

MEDIA STATEMENT

CATTI and bioMérieux Canada are joining forces to support the development of a qualified workforce in advanced therapies

CATTI, Canadian Advanced Therapies Training Institute, and bioMérieux Canada are combining their respective strengths to enhance the training of the workforce in advanced therapies and the production of quality control solutions (for the pharmaceutical industries).

InDevR VaxArray®

MEDIA STATEMENT

Partnership: bioMérieux and InDevR take vaccine quality control to the next level

bioMérieux is making a $5 million investment in InDevR, and will be the exclusive distributor in Europe of VaxArray®, a state-of-the-art vaccine quality control platform developed by the American company. 

Woman handling lab instrument

MEDIA STATEMENT

bioMérieux and AnaBioTec Announce Partnership to Support the Implementation of Rapid Mycoplasma Testing

In May 2024, bioMérieux entered into a strategic partnership with AnaBioTec, an analytical service provider for pharmaceutical, biopharmaceutical and cell-based drugs, from early to late phases of development. Both companies intend to advance and transform Mycoplasma testing for the biopharmaceutical and Cell & Gene Therapy (CGT) industries, in Europe.
3P enterprise

MEDIA STATEMENT

bioMérieux Launches 3P® ENTERPRISE

bioMérieux, a world leader in the field of in vitro diagnostics, launches 3P® ENTERPRISE, an innovative solution designed to ensure environmental monitoring processes are fully efficient and under control at all times.

MEDIA STATEMENT

French Bioproduction Sector Announces Launch of World First

The French bioproduction sector – in the form of a top-tier industrial consortium led by bioMérieux, Novasep, Sanofi and Servier – announced the launch of immerscio.bio at the France Bioproduction 2022 Congress on April 7 and 8. immerscio.bio will cover the entire bioproduction chain, employing a range of innovative digital solutions to promote the understanding of processes and the ownership of professional practices.

MEDIA STATEMENT

The Campus Biotech Digital Joins Forces With Atos

The Campus Digital Biotech receives funding under the “engineering of vocational and on-the-job training and innovative offers” component of France's Investments for the Future programme. Launched in December 2020 and run by a leading industrial consortium (bioMérieux, Novasep, Sanofi and Servier), the Campus is partnering with three major players in the digital sector: Atos, IBM and Microsoft.

MEDIA STATEMENT

The French Bioproduction Sector Announces the Creation of Campus Biotech Digital

As part of its contract*, the French bioproduction sector is launching an ambitious training platform: Campus Biotech Digital. Unique in the world in the bioproduction field, it will help develop skills in this field to meet new technological challenges. Covering the entire bioproduction chain, Campus Biotech Digital will use various innovative digital solutions to promote understanding of processes and the appropriation of professional practices.

MEDIA STATEMENT

Comparison of Bacterial Endotoxin Testing Methods 

Current bacterial endotoxin testing systems can be labor-intensive and time-consuming, involving several manual pipetting steps. In our quality control laboratory, annually, we test about 15,000 samples of different grades of purified water, WFI and water samples taken to validate cleaning procedures for endotoxins. We are currently using the Kinetic-QCL™ assay which is a pharmacopeia method that provides reliable results. We compared this assay with another Limulus amebocyte lysate (LAL)-based assay (Endosafe®-MCS) and an alternative endpoint fluorescent recombinant Factor C (rFC) assay (ENDOZYME II GO®).

MEDIA STATEMENT

Launch of BIOFIRE® MYCOPLASMA Test for Mycoplasma Detection

bioMérieux, a world leader in the field of in vitro diagnostics, has announced the launch of BIOFIRE® MYCOPLASMA, an innovative test for mycoplasma detection in pharmaceutical products used for biotherapeutics (antibodies, hormones, cell and gene therapies, etc.), the most vibrant sector in the pharmaceutical industry.

MEDIA STATEMENT

Endotoxin Detection - Recombinant Factor C

Published in EuropeanPharmacopoeia Supplement 10.3, the new general chapter 2.6.32. Test for bacterialendotoxins using recombinant factor C describes a test for bacterial endotoxins (BET) that can be used as an alternative to the classic limulus amoebocyte lysate (LAL)-based methods for the quantification of endotoxins from gram-negative bacteria. The method described involves the use of a recombinant factor C rFC based on the gene sequence of the horseshoecrab and fluorimetric detection, in keeping with the kits currently available on the European market.

MEDIA STATEMENT

bioMérieux Launches ENDOZYME® II GO

Marcy l’Étoile, May 31, 2018 – bioMérieux, a world leader in the field of industrial microbiological control, announces the launch of ENDOZYME® II GO, a new endotoxin test in the bioMérieux ENDONEXTTM range of recombinant horseshoe crab Factor C (rFC) assays. This new assay resulting from the combined expertise of bioMérieux in microbiology and Hyglos GmbH in endotoxin detection enables endotoxin testing in pharmaceutical grade water, injectable drugs and other pharmaceutical products. This new test allows an easy and fast workflow, and is particularly adapted to raw materials and final product testing.

MEDIA STATEMENT

bioMérieux Receives FDA Clearance for BPA and BPN Culture Bottles Used With BACT/ALERT® VIRTUO®

Marcy l’Étoile (France) – December 18, 2018 – bioMérieux, a world leader in the field of in vitro diagnostics, announces that its culture bottles BACT/ALERT® BPA and BPN have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for quality control testing of leukocyte-reduced apheresis platelet (LRAP) units with the BACT/ALERT® VIRTUO® fully automated blood culture system.

MEDIA STATEMENT

bioMérieux Strengthens Its Quality Control Offering in Advanced Therapy Medicinal Products (ATMP)

Marcy-l'Étoile, France and San Jose, California, May 6th, 2021 - bioMérieux is designated as the exclusive distributor of Accellix products in China, Japan, Australia and South Korea. Under the agreement signed on February 18th, 2021, bioMérieux will perform the full range of sales, supply and service activities in the Asia Pacific region. The Accellix technology enables complex cellular quality control (QC) testing of cellular therapies, at the point of manufacturing from starting material to final product.