Pharma Quality Control Media Statements

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 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).

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.

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.

Pharma Quality Control Media Statements

Pharma Quality Control Media Statements

Pharma Quality Control Media Statements

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®).

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.

Pharma Quality Control Media Statements

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.

Pharma Quality Control Media Statements

Pharma Quality Control Media Statements