Skip to main content

A young Asian woman is choosing medicine

Resources on Protecting Patient Health

Your dedicated space for key information to better understand how our products and solutions help you to solve your pharmaceutical manufacturing challenges.

Browse through our webinars, case studies, whitepapers, videos, scientific posters and articles to learn more!

Pharma Quality Control

View the articles below to learn more about the importance of diagnostics in protecting patient health through safe pharmaceutical products.

From webinars, to whitepapers, case studies and other scientific content, we've got you covered!

Industry

Challenge / Topic of Interest

Solution

Clear All

The Hunt for the Missing Endotoxin

This white paper reviews the causes contributing to low endotoxin recovery (LER), the impact it creates, as well as solutions which can rectify the issues it results in. We also discuss the advantages and disadvantages of developing your de-masking protocols in-house, and how you can use the ENDO-RS® de-masking tool kit to make the process easier from beginning to end. Following this, we outline the pros and cons of outsourcing your de-masking project, what you should look for in a third-party company, and why you can and should trust bioMérieux with your de-masking protocol development.

Image illustration

Embrace the Future of Microbial Detection in Cell and Gene Therapy with USP <72>

Automated growth-based methods have long been utilized to test microbial contamination across a diverse range of pharmaceutical products, including cell and gene therapy (C&GT) products. These innovative therapies are revolutionizing the treatment of life-threatening and chronic diseases, offering significant benefits to patients. Due to their short shelf life, these products must be administered promptly and tested for microbial contamination to ensure patient safety.

BACT/ALERT^® 3D: From Alternative to Routine for Testing Cell and Gene Therapy Products

This on-demand webinar explores rapid sterility testing in Cell and Gene therapy, covering the pivotal role of rapid testing and evolving regulations. Discover why the BACT/ALERT® is the trusted choice for microbial contamination testing and optimize your processes for enhanced quality control and compliance!

ENDOTOXIN-TESTING

European Pharmacopoeia paved the way for rFC adoption: Integration of Recombinant Factor C (rFC) into Chapter 2.6.14

The European Pharmacopoeia (Ph. Eur.) is undergoing a transformative update to its Bacterial Endotoxin Testing (BET) standards, signaling a new era in pharmaceutical quality control. With the introduction of Method G: Fluorimetric end-point method using recombinant Factor C (rFC) into Chapter 2.6.14, “Bacterial Endotoxins,” the Ph. Eur. is paving the way for definitive compendial adoption of a modern, sustainable substitute for the traditional Limulus amoebocyte lysate (LAL) assay.

TBN-ISCT-3P

Digitalization and Automation of the Environmental Monitoring Process in C&GT Manufacturing GMP Facilities: Solution to Leverage QC Operational Efficiency, Compliance and Optimize Resources Allocation

Microbial Environmental Monitoring (EM) is crucial to assure patient safety. The visual end point reading of petri dishes has been used for decades without a true performance assessment. Besides, there is growing interest in EM automation technologies.

Optimizing Automated Growth-Based Methods for Faster Sterility Release Testing of Cell & Gene Therapy Products

Optimizing Automated Growth-Based Methods for Faster Sterility Release Testing of Cell & Gene Therapy Products

Automated Growth-based methods are used for rapid detection of microbial contamination in pharmaceutical products such as Cell and gene therapy (CGT). For therapies on the critical path to patient treatment, every day/hour gained on release testing is crucial to accelerate delivery to patients in need.

TBN-ISCT-BIOFIRE

Automated Nucleic Acid Amplification Assay for Mycoplasma Detection in Cell and Gene Therapy Products

Cell and gene therapies (C&GT) or Advanced Therapeutic Medicinal Products (ATMP) are innovative medicine developed to treat cancers, rare diseases, autoimmune disorders, and injuries. As these therapies utilize living cells, they produce a product with a short shelf life. While microbiological examination of cell-based products is critical to ensure patient safety, challenges exist to enable testing and obtaining rapid results prior to patient infusion.

3P SMART BIOBALL performance aseptic processing

Accurately Managing Your Aseptic Processing By Using The Right Culture Media: A Study On 3P® SMART PLATES and BIOBALL®

Accuracy of Environmental Monitoring (EM) is key in maintaining control and preventing contamination issues in pharma companies, and culture media plays a pivotal role in Environmental Monitoring programs. Culture media must provide accurate, reliable, and consistent results. Their ability to promote microorganisms’ growth must be demonstrated and validated throughout the shelf-life of the culture media, using different batches, and intra- and inter-batch reproducibility tests inoculating strains described in the Pharmacopoeias and pharmaceutical plant environmental isolates are recommended to be carried out.

The Future of Endotoxin Testing: USP Chapter <86> and the Shift to Recombinant Methods

For the past 50 years, the Limulus amebocyte lysate (LAL) test has served as the foundation of drug and medical device manufacturing endotoxin control. Now, however, the United States Pharmacopeia (USP) has recognized the need to transition to recombinant methods.

automate envionrmental monitoring 3P biomerieux

The Future of Environmental Monitoring: Integrating and Validating the Next Generation of Automated Solutions

For drug developers, manufacturers and diagnostic testing companies such as bioMérieux, the safety of their end consumer – patients – is their greatest priority. Even minor lapses in production processes or product testing of pharmaceuticals can create significant risks for the safety of patients, as well as undermining public confidence in the wider healthcare industry. Companies working in this field must pay attention across the whole product chain to reduce risks and center patient safety. Such measures include ensuring the quality and consistency of raw materials, handling and storing raw materials appropriately, initiating well-designed manufacturing processes that minimize contamination and conducting effective environmental monitoring (EM).

Woman in pharamacy checks label on box

Mycoplasma hyorhinis

Mycoplasma is a genus of gram negative bacilli belonging to the Mollicutes class. Mollicutes include Mycoplasma and Acholeplasma. Mollicutes lack a cell wall and are of very small size (200-300 nm) and have a small genome. Since Mollicutes cannot produce many of the enzymes needed to survive they are parasitic on eukaryotic cells.

bioball pharmaceutical manufacturing

Why Pharmaceutical Developers Use BIOBALL^®

The intellectual properties and proprietary methodologies used in making BIOBALL® redefine what was considered as quantitative microbiology and make it simple to get precise and accurate quantitative microbiological quality controls batch after batch.

Woman in pharamacy checks label on box

Prevention and Control of a Staphylococcus aureus Infection

Staphylococcus aureus, is a species of Gram-positive spherical bacteria that commonly causes surgical and skin infections, bacteremia (bacteria in the blood) and food poisoning. It’s a ubiquitous microorganism, and can be found on the skin of warm blooded animals.

Woman in pharamacy checks label on box

Candida albicans

Candida albicans is an opportunistic pathogenic yeast1 and a common member of human gut flora. It is usually a commensal organism, but it can become pathogenic in immunocompromised individuals under certain conditions.

Woman in pharamacy checks label on box

Acholeplasma laidlawii

Acholeplasma is a genus of gram negative bacilli belonging to the Mollicutes class. Mollicutes include Mycoplasma and Acholeplasma. Mollicutes lack a cell wall and are of very small size (200-300 nm) and have a small genome. Since Mollicutes cannot produce many of the enzymes needed to survive they are parasitic on eukaryotic cells.

Woman in pharamacy checks label on box

How Does Pseudomonas aeruginosa Affect the Pharma Industry?

Pseudomonas aeruginosa is a gram negative, rod-shaped bacterium found widely in the environment, such as in soil, water, and plants. They usually do not cause infections in healthy people, but if they do, it is generally mild. It can cause disease in plants and animals, including humans.

bioprocess testing workflow

Build Out Your Bioprocess Testing Workflow

Bioprocessing is a type of manufacturing that uses living cells to produce a product. In pharmaceutical bioprocessing, a living cell is manipulated to manufacture the drug of interest in bioreactors and is then purified and formulated to create the end product.

Woman in pharamacy checks label on box

Cutibacterium acnes Gram Positive Bacteria Causing Infection

Cutibacterium acnes (C. acnes) is a Gram positive bacteria that prefers anaerobic (without air) growth conditions1. Cutibacterium acnes can be found on the skin of virtually every human, and it is one of the bacteria that can cause acne.

Scientific Study Summary: BIOFIRE^® Mycoplasma For Cell & Gene Therapy Samples

Two cell therapy and four bioproduction manufacturers evaluted the BIOFIRE® FILMARRAY® 2.0 — interested in the results in an easy-to-digest format? Download a one page Scientific Study Summary that details the study's objectives, outline, and conclusion!

BACT/ALERT Product

Why is BACT/ALERT® the method of choice for rapid sterility testing?

BACT/ALERT® allows virtually anyone to test for product contamination anywhere, at any time. This proven solution is compatible with even the most complex matrices and can be used for both in-process and release testing.

Woman in pharamacy checks label on box

Bacillus subtilis

Bacillus subtilis is a gram-positive bacteria found in soil and the gastrointestinal tract of ruminants and humans. It is rod-shaped and can form a tough, protective endospore, allowing it to tolerate extreme environmental conditions1.

Woman in pharamacy checks label on box

Aspergillus brasiliensis

Aspergillus brasiliensis is a fungus and is one of the most common species of the genus Aspergillus. It is ubiquitous in soil, a common food contaminant, and is also regularly reported from indoor environments such as industrial plants.

Streamlining Pharmaceutical Quality: The Power Of Automated Environmental Monitoring

Traditional, manual methods of environmental monitoring can be subject to numeration errors as well as data traceability and integrity issues, which result in overall inefficiency. Want to uncover how automated methods outperform these traditional approaches? Download our infographic now and gain exclusive insights.

Scientific Study Summary: BIOFIRE^® Mycoplasma For Bioproduction Samples

Four bioproduction manufacturers evaluted the BIOFIRE® FILMARRAY® 2.0 system — interested in the results in an easy-to-digest format? Download a one page Scientific Study Summary that details the study's objectives, outline, and conclusion!

species level identification malditof biomerieux

Mass Spectrometry MALDI-TOF Technology Species Level Identification

Matrix-assisted laser desorption ionisation (MALDI) uses a laser to absorb energy from a matrix to create ions with minimal fragmentation from large molecules.

BIOBALL usp60 complex strains

BIOBALL® Burkholderia cepacia Complex Strains Performance Testing for USP <60> Growth Promotion Requirements

Over the years, presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the U.S. Burkholderia cepacia is one of the most prominent objectionable microorganism associated with 102 non-sterile drug recalls from 2012 to 2019(1,2). It is an opportunistic pathogen and has a distinctive ability to overcome antimicrobial preservative systems.

Rapid Mycoplasma Testing

bioMérieux's BIOFIRE® MYCOPLASMA, revolutionizes the way we perform mycoplasma control tests for mycoplasma.

BIOBALL^® - Where Accuracy, Precision, Efficiency and Consistency Matters the Most

With as few as 4 simple preparation steps, BIOBALL® helps bring time savings and optimize workflows, improving overall lab efficiency and productivity.

Strengthen Cell & Gene Therapy Production with Smart Quality Testing.

Strengthen Cell & Gene Therapy Production with Smart Quality Testing

Today, cell and gene therapies, along with other cutting-edge scientific approaches, are reshaping how diseases are treated or cured. These innovative treatments offer new hope for patients, but developing them presents many challenges due to a complex manufacturing process.

ENDONEXT - The evolution of Endotoxin Testing

ENDOZYME^® II GO

Our sustainable ENDONEXT range of endotoxin detection assays based on Recombinant Horseshoe Crab Factor C (rFc) eliminates the need to harvest horseshoe crab blood and helps make quality control more precise and efficient.

Automated Solutions

Advanced QC Solutions for Cell and Gene Therapy Manufacturing

Cell and gene therapies hold enormous potential for treating diseases like cancer and rare conditions. However, ensuring their safety and efficacy requires rigorous quality control throughout the manufacturing process.

BIOBALL^® Video Tutorials

How to use BIOBALL®

CAR-T CELL THERAPY - 3-PART VIDEO SERIES

CAR-T Cell Therapy – 3-part Video Series

CAR-T cell therapy is a personalized, one-time treatment that reprograms a patient's T cells to detect and destroy cancer cells. This therapy could be the last line of treatment for many patients.

How to implement single temperature incubation in your EM routine?

How To Implement Single Temperature Incubation In Your EM Routine

In this webinar, learn from environmental monitoring expert Laurent Leblanc about the "One Media / One Temperature" approach, and gain insights into overcoming challenges in transitioning between incubation temperatures while leveraging automation for enhanced productivity.

webinar title

Annex 1 and Environmental Monitoring Program

Annex 1 and Environmental Monitoring Program - Implementation And Justification of The Best Practices In Routine - What is new? How to implement the changes? - EM program and Contamination Control Strategy - Example of Risk Analysis Methodology - EM program and Data Management

webinar title

Organizational Readiness for an FDA Audit of a 503B Compounding Pharmacy

Listen to Lisa McChesney-Harris, PhD, CEO, CSO and Founder of Prompt Praxis Laboratories, discuss how to apply strategies for achieving an audit-ready organization, maintaining vigilant management oversight in this bioMérieux-sponsored webinar, Organizational Readiness for an FDA Audit of a 503B Compounding Pharmacy, with the American Pharmaceutical Review.

From Challenge to Change: Implementing Digital and Automation Projects in Pharma

The experts Marie Jorna Bled (Test & Release Excellence Lead Director, MSD) and Alicia Ruiz Mahillo (Group Quality Microbiology Manager, COMPASS by FAMAR ) joined by Arnaud PARIS - Pharma Quality Control (Business Director, bioMérieux Pharma Quality Control) dive into the journey of implementing change, from identifying impactful problems to building a business case and convincing stakeholders.

Rapid Implementation of NAT technology for Mycoplasma with AnaBioTec & BIOFIRE Mycoplasma

Rapid Implementation of NAT technology for Mycoplasma with AnaBioTec & BIOFIRE® Mycoplasma

In this insightful webinar, you'll learn how rapid Nucleic Acid Amplification Techniques (NAATs), such as BIOFIRE ® Mycoplasma, can be seamlessly implemented as an alternative method for Mycoplasma detection in pharmaceutical production.

webinar title

Contamination Control Challenges Facing Cell Therapy Facilities

The presentation aims to provide an overview of challenges that can be faced with the knowledge that a one size fits all approach cannot be taken.

Webinar - Molecular Innovation for Food Pathogen Testing

Next Generation mRNA Vaccine CQA Analytics

✅ Why analytical methods developed for traditional monovalent vaccines are a bottleneck for mRNA vaccine development and manufacturing ✅How InDevR utilizes decades of multiplexed assay development and manufacturing experience to accelerate mRNA vaccine development ✅ The ways InDevR continuously monitors and verifies assay kit performance for new strains ✅ How InDevR’s expert services team can develop custom off-the-shelf assays specific to your vaccine samples

webinar title

CBER Perspective on Evaluation and Implementation of Rapid Microbial Methods

Listen to CAPT Simleen Kaur and Lori Daane discuss CBER’s current thinking about validation and implementation of rapid microbial methods and their evaluation to demonstrate the suitability of rapid microbial methods.

webinar title

Commercial Cell Therapy Experience Using Mycoplasma NAT for Product Release

Autologous cell therapy products are patient-specific therapies that use cells harvested from a single patient to treat that same patient. Final product release tests that require minimal sampling, produce rapid valid results, and are inexpensive to use is critical because each lot of final product requires testing prior to implantation in the patient. Rapid detection of mycoplasma is essential for product release testing of autologous cell therapy products such as MACI® (autologous cultured chondrocytes on porcine collagen membrane).

Ultra-rapid microbial detection in cell & gene therapy products

Ultra-rapid Microbial Detection in Cell & Gene Therapy Products: the Closest you can be to Real-time Release

When innovators are focused on shortening manufacturing process to meet patient demand for life saving therapies, there is a need for new quality control analytical method solutions that are fast enough to keep pace with faster manufacturing approaches. This poster explores a new ultra-fast sterility solution for cell and gene therapeutic products.

webinar title

High Throughput Endotoxin Testing

Automate your endotoxin testing with bioMérieux's ENDOZYME® II GO on Tecans Fluent automated liquid handling workstation - no manual vortexing and no dilutions.

webinar title

Regulatory Submission Strategy for Implementation and Validation of a New PCR-Based Technology for Mycoplasma Testing

This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.

webinar title

1-hour mycoplasma testing

In this 15-minute webinar you will learn how you can maximize operational efficiency and save costs with 1-hour mycoplasma results using the BIOFIRE® Mycoplasma system.

Current Status and Overview of the Rapid Microbiological Methods and Endotoxin Microbiology USP Chapters under Development

An Overview of Recent USP Bacterial Endotoxins Standards Development. Detection of bacterial endotoxins is a critical quality attribute of parenteral pharmaceuticals and medical devices. Bacterial endotoxins are cell wall components of Gram-negative bacteria, ubiquitous in nature, difficult to destroy and can cause pyrogenic responses or worse.

webinar title

ATMP Manufacturing - QC Micro Phase Selection

Don't miss this webinar with our partners, the National Institute for Bioprocess Research and Training (NIBRT). This session focus on quality control (QC) microbiology in the different types of advanced therapy medicinal products (ATMP) manufacturing.

webinar title

Leveraging Instrumentation to Accelerate Release Testing & Minimize Human Input

This talk will focus on the analytical testing needed for the release of cell and gene therapy products. A lot of focus has been on improvements and automation of equipment used in manufacturing of cell therapies such as bioreactors. However, to improve and speed up the release testing, this needs to be done also on the analytical side.

How to implement single temperature incubation in your EM routine?

Environmental Monitoring: Expert Discussion on the Benefits of a Single Incubation Temperature

The Environmental Monitoring program (EM) is an important quality control for the pharmaceutical manufacturing operations. The most common usage is doing sequential incubation time and temperature to maximize the range of recovery of the flora. The current practice is to start with the lower temperature (22,5°) to enhance the growth of environmental strains such as molds and to switch to the higher temperature (32,5°C) to recover human skin microorganisms.

webinar title

BIOBALL^® 3-Part Webinar Series

In this three-part webinar series, you’ll learn about BIOBALL® from industry experts Dr. Megha Bajaj and Dr. Tony Cundell. Discover BIOBALL® best practices, applications in non-sterile product testing methods, our in-house Isolate service, and more.

webinar title

Streamlined mRNA Vaccine Characterization with the VaxArray Platform

In this webinar, Dr. Lacey will showcase the utility of the VaxArray platform throughout mRNA vaccine development. He will specifically focus on off-the-shelf VaxArray assays including the recently released 5’ CapQ Assay for assessing mRNA integrity as well as the OmniFlu HA/NA Assay for multiplexed analysis of expressed influenza antigens. Additionally, he will highlight the essential role that Sino Biological plays in ensuring that InDevR has the most up-to-date and effective reagents for testing and updating VaxArray assays.

How can the latest regulatory advances in endotoxin testing support your green agenda?

This webinar delves into the ground-breaking developments in synthetic Bacterial Endotoxin Test (BET) methods, as well as the implications of the new USP Chapter <86> for Endotoxin Testing.

rFC: from scientific breakthrough to implementation

The detection of Bacterial Endotoxins in parenteral pharmaceuticals and medical devices is critical to patient safety and has traditionally relied on the Limulus Amebocyte Lysate (LAL) method. However, with the introduction of recombinant Factor C (rFC) and the adoption of USP Chapter <86>, the industry is taking a major step towards reducing the reliance on animal-derived materials while simplifying and modernizing endotoxin testing.

State Of The Art Automation For Endotoxin Testing

They say “A rising tide lifts all boats” and this is true for advances in automation as applied to various analytical test methods. Have you checked the state of automation capabilities recently? Read the white paper to learn more.

Suitability of a Single Incubation Temperature for Environmental Monitoring Programs

This white paper discusses the challenges of one media/one temperature incubation, with a real case study and evaluates the sustainability of a single incubation temperature strategy for Environmental Monitoring.

Environmental Monitoring for Pharmaceuticals

In microbiology and pharmaceutical development, environmental monitoring (EM) is a process that determines the quality of a controlled environment via microbial data collection.

BIOFIRE MYCOPLASMA

Easy 1 Hour Mycoplasma Detection in Cell Therapy Samples

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).

BIOBALL® Burkholderia cepacia Complex Strains Performance Testing for USP <60> Growth Promotion Requirements

This white paper provides an evaluation of BIOBALL® MultiShot 550 Bcc range recovery levels on bioMérieux BCSA (Ref 33631) ensuring they are acceptable as per growth promotion and indicative properties testing requirements of USP <60> chapter.

Bacterial Endotoxin Testing: 10 Reasons to Choose Recombinant Factor C

Recombinant horseshoe crab Factor C (rFC) methods are the latest state-of-the-art solution for effective bacterial endotoxin testing (BET). This whitepaper reviews the advantages of Recombinant horseshoe crab Factor C (rFC) over the BET methods currently in widespread use. We compare the performance of LAL reagents with rFC, and summarize the evidence supporting our 10 reasons to choose rFC.

How Drug Developers Use a Feasibility Study to Protect Their Investment

A feasibility study is probably the single most important consideration when it comes to changing your method of application. One will quickly confirm your product compatibility and method. bioMérieux provides high-quality products and applies these exact standards to our feasibility studies.

Waste in Endotoxin Detection Assays LAL vs rFC

From traditional to alternate endotoxin testing methods used for product release testing, there is an opportunity to waste less reagent and generate cost savings.

EM Data Quality Management

Drug developers rely on data quality management (DQM) during development and manufacturing for a number of reasons and, therefore, must start with a clear data management strategy in order to organize and protect the integrity of the products, along with the safety and well-being of patients.

Detection of Small Events Environmental Monitoring Culture Media

USP chapter <1116> describes Environmental Monitoring (EM) as a key element to ensure control of aseptic processing areas. The quality of the drugs manufactured is directly linked to the capacity to minimize microbial contamination.

Single Temperature Analysis for Environmental Monitoring Samples

ENVIRONMENTAL MONITORING (EM) is one of the main microbiological controls that pharmaceutical industries perform to ensure the safety and efficacy of pharmaceutical products. To efficiently control the quality of these products, the presence of potential microbial contaminants must be monitored. Although the traditional method is extremely manual, variable and error-prone, it remains the standard procedure used in industry for hundreds of millions of samples per year.

Adoption of rFC for bacterial endotoxin testing

With industry’s push to build a more diverse global supply chain, we find ourselves at a tipping point for the widespread adoption of alternative solutions like rFC — driven as much by industry, if not more, than regulators.

Automated nucleic acid amplification assay for mycoplasma detection in cell and gene therapy products

Cell & Gene therapies (CGT) or advanced therapeutic medicinal products (ATMPs) are innovative medicines developed to treat cancers, rare diseases, autoimmune disorders and injuries. As these therapies utilise living cells, they produce a product with a short shelf life. While microbiological examination of cell-based products is critical to ensure patient safety, challenges exist to enable testing and obtaining rapid results prior to patient infusion.

Header Image Non-Growth-Based Alternative Sterility Testing

Non-Growth-Based Alternative Sterility Testing

The SCANRDI® is a non-growth-based rapid microbial method (RMM) that detects not only viable microbial cells that can be isolated using a broth or agar plate but also viable but non-culturable (VBNC) microorganisms, including stressed and fastidious microorganisms that may not be recovered by standard culture methods, making SCANRDI® more sensitive than growth-based methods.

Overcoming Mycoplasma Testing Challenges in Cell and gene Therapy Manufacturing with BIOFIRE®

The BIOFIRE® Mycoplasma test is a closed-system sample-to-answer nucleic acid test that is designed to report the presence/absence of over 130 mycoplasma species in less than an hour. It requires minimal hands-on time and contains everything needed to run a molecular test in a sealed pouch.

Automated 1 Hour Mycoplasma Detection in Bioproduction

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells.

Sustainable Glass Packaging and Test Reagent Use Practices that Significantly Reduce Waste.png

Sustainable Glass Packaging and Test Reagent Use Practices that Significantly Reduce Waste

Nine out of 10 top global pharmaceutical companies have set targets to reduce their carbon footprint. One of the main driving forces behind the pharmaceutical industry’s efforts to reduce its carbon footprint is the rapidly changing regulatory environment following the Paris Agreement, ratified by 196 countries in 2015.

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.

expert interview title

Combatting 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.

expert interview title

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.

expert interview title

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.

expert interview title

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.

expert interview title

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.

expert interview title

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.

expert interview title

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.

expert interview title

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"

expert interview title

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.

expert interview title

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!

expert interview title

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.

expert interview title

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

expert interview title

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.

expert interview title

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.

How did Cosmebac Improve Microbiological Testing Process With CHEMUNEX^®?

Founded in 1993, Cosmebac is a microbiology laboratory that is a part of the Cosmepar group. They focus on safety testing for cosmetic products for various clients, resulting in their status as an expert when it comes to regulations and international testing standards. In order to achieve their goal of helping their clients release their products faster, they needed to improve upon the analysis time during testing. Mr. Charles Reinier, the Microbiology Laboratory Manager at Cosmebac, decided to implement the CHEMUNEX® D-COUNT® from bioMérieux.

BIOCAD’s Quest for a Reliable Microbiological Quantitative Reference Material

BIOCAD is Russia’s leading innovative biotechnology company, combining a world-class research and development center, ultra-modern pharmaceutical and biotechnological manufacturing facilities, with a preclinical and research infrastructure compliant with international standards.

rapid sterility testing using bact alert 3D

How a Top 5 Pharma Company Enhances Production Efficiency through Rapid In-Process Testing

A top 5 pharmaceutical company incorporated automated, rapid sterlity testing using BACT/ALERT® 3D. Their approach was designed to detect any microbial contamination at the earliest possible opportunity and has been key in maintaining control over their production processes.

Different colored cosmetic creams on a white background

How Shiseido Increased the Efficiency of Microbiological Controls With CHEMUNEX^®

Shiseido is a globally-renowned manufacturer of cosmetics and fragrances. In this case study, see why Shiseido used CHEMUNEX® for quality control of bulk raw materials and in product development.

How Thalgo Increased Productivity With CHEMUNEX^®

The market-leading marine cosmetics firm Thalgo regularly processes large volumes of aqueous products with seaweed extracts on demanding timescales and to strict regulatory requirements. With a large and fast-moving supply chain, Thalgo is required to perform certified analysis on its consumer products quickly and efficiently in order to ensure continued commercial success.

How did L’Oréal Optimize Microbial Testing With the CHEMUNEX^® System?

L'Oréal is the largest cosmetics and beauty product manufacturer in the world. As an owner of multiple international brands with presence in 130 countries globally, controlling the microbial content in their products is of the utmost importance. One particular site in France, Gemey Maybelline, is a center of production for make-up items such as foundation, lip gloss and nail polish.

Endotoxin Testing: New Horizons with Recombinant Reagents

A comprehensive analysis of historical context, current practices, and future directions in Europe and the United States.

Harnessing the Power of CAR-T Cell Therapies Without Compromising Quality Control

Download the white paper to learn about CAR-T cell therapy, which uses a patient’s own genetically modified T cells to target and kill cancer cells.

ENDOZYME_II_GO

A Step-by-Step Approach to Effective Endotoxin Testing

An endotoxin test involves several critical steps to ensure accurate and reliable results. Here are the 10 key elements of an endotoxin test.

Image Differentiation within the Bacillus Cereus and Bacillus Subtilisgroups with Maldi-Tof Poster

Differentiation within the Bacillus Cereus and Bacillus Subtilisgroups with Maldi-Tof

Bacillus cereus group is composed of B. anthracis, B. cereus, B. cytotoxicus, B. mycoides, B. pseudomycoides, B. thuringiensis and B. weihenstephanensis. Bacillus subtilis group is composed of B. amyloliquefaciens, B. subtilis, B. vallismortis, B. velezensis. They are well known pathogens among the Bacillus genus and can be a source of human infection as well as contaminants in agriculture and food industry. These species are very similar and their differentiation is cumbersome but essential notably in term of epidemiology. Today, no mass spectrometry system is able to differentiate them in routine. The biochemical or molecular techniques are quite fastidious, long and expensive and not always conclusive. The objective of this study was to develop a simple and user-friendly method to separate these species by MALDI-TOF.

Performance study BACT/ALERT® 3D growth promotion antimicrobial neutralization

BACT/ALERT® 3D is an effective, safe and proven solution for industrial sterility testing.