bioMérieux’s solutions aren’t solely focused on technology -they’re rooted in a steadfast dedication to quality service. Every day, we our goal is to serve our customers as fast as possible to optimize the uptime of our equipment and ensure the business continuity of our customers’ operations.

Quality is a key aspect of bioMérieux’s commitment. We believe the shared goal and responsibility of all bioMérieux employees is to understand customers’ needs and provide high medical value products and services that enhance public health worldwide. Every bioMérieux team member plays a role in guaranteeing the full execution of our quality standards

Endotoxins can cause very serious side effects in patients. To ensure patient safety, endotoxin detection is a necessary prerequisite — and regulatory requirement - for all injectable drugs and implantable devices. Our clients manage several tests each year, sometimes even tens of thousands. Their priorities are the simplification, automation and robustness of the tests.

bioMérieux sat down with experts from NecstGen to discuss the value of this partnership, the impact of rapid quality control, and the future of CGT.

“We show our partners that they can trust us to use all our means possible to achieve the goals that we have agreed on.” - Catherine Bach, Pharma QC Strategic Accounts Director

With a complete portfolio of Quality Control solutions, bioMérieux ensures the safety of patients undergoing cell and gene therapies. - Felix A. Montero Julian, PhD Scientific Director Pharma Quality Control 

Our 3P® ENTERPRISE solution can really make a difference by helping a faster drug release to address the patients’ needs.” - Laurent Leblanc, R&D Manager

bioMérieux had the opportunity to sit down with Ashley Trueheart, former Director of Product Design and Development at Eagle Analytical (Eagle) to discuss how they provide customers the fastest time-to-results using SCANRDI®, a safe and proven method for sterile product release.

We anticipate reaching our breakeven point after approximately 11 months of final product testing — representing approximately $200,000 in savings over the next 5 years 

What’s new in the cell and gene therapy landscape? What is the role of quality control in efforts to scale up manufacturing of CGT products and alleviate talent constraints?

The Directorate for Health and Food Safety of the European Commission published the final version of the Annex 1 Manufacture of sterile medicinal products of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.

Cell and gene therapies, also called ‘living drugs’ are both as powerful as they are complex. Despite the impressive trials and life-changing impacts at the individual level, it’s still not possible to manufacture #celltherapies at scales that could benefit a wider range of patients.

Is the future of cell and gene therapy autologous or allogeneic? Which solid tumour may receive the first cell therapy treatment? How will the use of ATMPs in cancer care change our healthcare structures in years to come? Discover all this and more in this podcast with bioMérieux.

Collaboration has been a huge part of the COVID-19 pandemic response, but it is also hugely important in the development of various other therapeutics. In the second episode in our advanced therapy medicinal products (ATMPs) series Jérôme Larghero, Director of the Department of Biotherapies and the MEARY Center for Cell and Gene Therapy in the Hôpital Saint-Louis, AP-HP, and Julien Textoris, Vice President of Global Medical Affairs, Immunoassays and host response at bioMérieux, discuss the importance of collaboration between academia and industry in the development of ATMPs.

In this ‘Experts Interview’ feature published on CELL & GENE THERAPY INSIGHTS, Felix Montero Julian (Healthcare Scientific Director, bioMérieux) and Rey Mali (Vice President Sales and Marketing, Accellix) share their perspectives on current Quality Control challenges and special needs in cell and gene therapy production.

In this podcast, Rey Mali, Vice President Sales and Marketing, Accellix, and Félix Montero-Julian, Healthcare Scientific Director, bioMérieux discuss the difficulties in manufacturing and ensuring the quality of cell and gene therapies, why speed is particularly important in their quality control and some of the key technologies involved in these quality assessments.

In this ‘Ask the experts’ feature published on RegMedNet.com, a panel of key thought leaders share their perspectives on current obstacles and future developments in cell culture and contamination. For example, how can contamination of cell culture affect the final product? What challenges remain in the prevention of cell culture contamination?

Discover the second episode of our Endotoxin Talks video series with Glenn Gauvry, founder of the Ecological Research and Development Group.

Félix A. Montero Julian PhD, Global Scientific Director Healthcare Business talks about the emerging field of ATMP (Advanced Therapy Medicinal Products) and related requirements for microbial monitoring and control.

For this third episode, we had a conversation with Jack Levin, hematologist and inventor of the Limulus Amoebocyte Lysate method for Endotoxin Testing.

The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.

Bacterial endotoxin testing is undergoing dramatic change due to the emergence of recombinant Factor C (rFC) methods – techniques that can increase efficiency and precision compared to Limulus-based reagents.