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Expert Interviews

bioMérieux provides expert interviews, discussing the latest trends and innovation in Pharmaceutical QC.

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Future of ATMPS

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.

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What are ATMPs and Why Have They Become a Key Topic of Interest in the Pharmaceutical Industry?

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.

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How Eagle’s Approach Gives Its Customers a Huge Advantage

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.

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Accelerating Cell & Gene Therapies: Collaboration With NecstGen

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

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Pioneering Quality Control in Biomanufacturing of Cell and Gene Therapies

Lauren Coyle, Commissioning Editor, Cell & Gene Therapy Insights, speaks with Dhruv Sareen, Executive Director at Cedars-Sinai Biomanufacturing Center, and Jonathan Rodriguez, Quality Control Manager at Cedars-Sinai Biomanufacturing Center, about the roles of in-process controls, method validation, risk management, and automation in biomanufacturing.

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3P® ENTERPRISE Faster Drug Release to Address the Patients’ Needs

Our 3P® ENTERPRISE solution can really make a difference by helping a faster drug release to address the patients’ needs.

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How bioMérieux ensures the safety of patients undergoing cell and gene therapies

"With a complete portfolio of Quality Control solutions, bioMérieux ensures the safety of patients undergoing cell and gene therapies"

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Selkirk Pharma Implements 3P^® ENTERPRISE To Streamline Environmental Monitoring Processes

Selkirk Pharma is a U.S. based contract manufacturing organization specializing in the sterile fill and finish of injectable drugs, including vaccines and biological therapies. Their state-of-the-art facility in Spokane, Washington boasts cutting-edge technology and recently completed the implementation of 3P® ENTERPRISE.

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The Power of Partnership for Smooth Implementations

Implementations can be challenging. You need partners that will be there with you every step of the way, guiding you and adapting solutions to fit into your environment. Our expert tells more about our end-to-end approach!

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In-house endotoxin testing ROI

By bringing endotoxin testing in-house using the GOPLATE™ and the recombinant factor C (rFC) endotoxin detection assay by bioMérieux, a medical-device manufacturer forecasts an ROI in just 11 months.

Interview with Holger Grallert, Scientific Expert at bioMérieux’s Endotoxin Center of Excellence

Combining a Strong Innovative Spirit with Customer Vision

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.

ACM Pharma uses VITEK® MS PRIME to ensure their microbial identification activities and sustain their business.

ACM Pharma is a leading subcontracting laboratory dedicated to serving the Bio/Pharmaceutical, Medical Devices, Cosmetics, and Disinfectants industries. Their Operational Director explains why they chose and use VITEK® MS PRIME to ensure their microbial identification activities and sustain their business.

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Each Employee Plays a Role in Ensuring Quality

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

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Creating successful and valuable partnerships

Mutual respect is extremely important. We respect one another, so we get to know each other better. Another value that matters to us is transparency. This means being open about all the things that are going well, but also communicating about potential difficulties or demands that we are not in a position to fulfill. By being open about it, we will find a solution much more quickly. Lastly, confidence and trust are also essential to our relationships.

Interview with Philippe Prouff, Global Customer Services Manager

Enabling the Promise of Our Technology

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.

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Podcast: Cell Therapy Manufacture

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.

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Combating Quality Control Challenges and Special Needs of Cell and Gene Therapy Production

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.

Interview with Pr. Ding, Pioneer in rFC endotoxin testing

Celebrating innovation with Professor Ding: A pioneer in sustainable endotoxin testing

Professor Jeak Ling Ding is a world-renowned pioneer in the field of molecular biotechnology. We spoke with Professor Ding to learn more about her career defining breakthrough to genetically engineer recombinant Factor C, and the importance of creating a sustainable and ethical alternative to replace traditional methods of endotoxin testing.

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Evolving QC for Cell & Gene Therapy - What's new in the Cell and Gene Therapy Landscape?

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 Power of Partnership for Smooth Implementations

Implementations can be challenging. You need partners that will be there with you every step of the way, guiding you and adapting solutions to fit into your environment. Our expert tells more about our end-to-end approach!

Rapid Methods: 4-Hour Time-to-Results

Since sterile compounded drugs have a short shelf life, a rapid Microbial detection method like SCANRDI® can reduce the time to results (TTR) from 14-days to as little as 4 hours or less. This helps alleviate the TTR bottleneck in the release process, while still providing a reliable and robust finished-product sterility test.

Why 4 Hours or Less Makes a Big Difference

As health-system pharmacies grapple with ways to address high drug costs, shortages, and labor turnover, many are turning to 503B compounding pharmacies to outsource their compounding needs, reports Pharmacy Times. Subsequently, this is putting pressure on 503Bs to increase capacity and keep pace with demand.

Advanced Solutions for Bacterial Endotoxin Testing

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.

Low Endotoxin Recovery

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.

Cell Culture and Contamination

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.

Collaboration in ATMP Development

Collaboration has been a huge part of the COVID-19 pandemic response, but it is also important in the development of various other therapeutics. Listen to the second episode in our advanced therapy medicinal products.

ATMP Manufacturing and QC

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.

EU GMP Annex 1 Manufacture of Sterile Medicinal Products Finally Published!

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.

Screenshot from Youtube video: Glenn Gauvry Endotoxin talks

Endotoxin Talks: Interview With Glenn Gauvry

Endotoxin Talks, Episode 2 : how RFC helps with improving the situation of the horseshoe crabs?

Screenshot from Endotoxin Talk Youtube Video: Jack Levin Endotoxin Talk

Endotoxin Talks: An Interview With Jack Levin

Endotoxin talks: the transition from LAL to RFC, as seen by Jack Levin

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Your Environmental Monitoring Program is More Expensive Than You Think

A study on the Cost of Quality and solutions to keep them down without compromising on quality.