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

Image Whitepaper - New Standardized Methodology to Evaluate Environmental Monitoring Plates Inspection Using an Automated System.

New Standardized Methodology to Evaluate Environmental Monitoring Plates Inspection Using an Automated System

To efficiently control the quality of pharmaceutical products, manufacturers must monitor for potential microbial contaminants. This is typically performed using irradiated culture media in Petri plates throughout the production process, especially within clean rooms, isolators and controlled production environments.

Image Whitepaper - Accurate Identification of Pharmaceutical Environmental Microorganisms

Accurate Identification of Pharmaceutical Environmental Microorganisms Using VITEK® MS

Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process from both a safety as well as an economic point of view. Rapid and accurate identification of microorganisms can contribute to reduce cost and time linked to investigations and corrective actions.

Image Whitepaper - APR Whitepaper_Automated Methods for Environmental Control (EM)

A Recognized Rapid Microbiological Method for Cell & Gene Therapy Products: Regulation & Industrial Application

This white paper details how innovative microbiological technologies are revolutionizing sterility testing for Cell and Gene therapy products. You'll learn the validation guidelines for alternative microbiological methods and gain understanding of the regulatory evolution and acceptance of rapid microbial testing.

Image Whitepaper - APR Whitepaper_Automated Methods for Environmental Control (EM)

Automated Methods for Environmental Control (EM) - Application of Automated Microbiology for Environmental Monitoring of Clean Rooms

Optimizing the control of bioproduction processes and the environmental monitoring of the biopharmaceutical industry is key to supporting the competitiveness of companies and no longer making quality control a bottleneck in the value chain of bioproduction but rather a real added value.

Scientist experimenting

Low Endotoxin Recovery case studies

This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference.

Image Whitepaper - Role of in-house isolates in pharmaceutical quality control

Role of in-house isolates in pharmaceutical quality control

Download this application note by Dr Megha Bajaj, Global Solution Manager at bioMerieux, to discover more about: - The relevancy of in-house isolates in microbiological QC testing - The selection and implementation of in-house isolates - Common microorganisms isolated in pharma labs.

expert interview title

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?

Woman in pharamacy checks label on box

Scientific Posters

Explore bioMérieux's collection of scientific posters showcasing research and insights in Food Safety & Quality and Pharma Quality Control.

Woman in pharamacy checks label on box

Scientific Library

Access bioMérieux's Scientific Library, providing the latest exeprt resources for Pharmaceutical Quality Control.

Woman in pharamacy checks label on box

Videos

bioMérieux provides resources and videos to help you better understand our products and solutions in Pharmaceutical Quality Control in Industrial Applications.

Woman in pharamacy checks label on box

White Papers

A selection of white papers from bioMérieux discussing the latest and greatest trends and innovation in Pharmaceutical Quality Control in Industrial Applications.

Woman in pharamacy checks label on box

Webinars

A selection of webinars from bioMérieux discussing the latest and greatest trends in Pharmaceutical Quality Control in Industrial Microbiology.

Woman in pharamacy checks label on box

Expert Interviews

A selection of expert interviews from bioMérieux, discussing the latest and greatest information in Pharmaceutical Quality Control in Industrial Applications.

Woman in pharamacy checks label on box

Case Studies

A selection of case studies from bioMérieux, providing the latest and greatest information in Pharmaceutical Quality Control in Industrial Applications.

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.

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.

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.

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.

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.

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.

Mycoplasma release test with low volume protocol: From sample to results in less than 1 hour

Improved Time-To-Detection of Slow Growers Microorganisms with an Automated Growth Based Method

Presenting data to showcase how optimization of BACT/ALERT® 3D DUAL-T incubation conditions can lead to notable improvements in time-to-detection.

Mycoplasma release test with low volume protocol: From sample to results in less than 1 hour

Mycoplasma release test with low volume protocol: From sample to results in less than 1 hour

Presenting a new Low Volume protocol that allows the inclusion of mammalian cells from high cell density products thus aligning with the upcoming EP guideline whilst providing the required level of detection (≤ 10 CFU/mL) as a mycoplasma release test.

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.

endotoxin testing rfc biomerieux

Revolutionize Your Endotoxin Testing

Embark on a 6-part journey designed to challenge the traditional norms in endotoxin detection.

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.

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).

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.

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.

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!

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.

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.

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.

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

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.

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

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.

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

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.

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

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.

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.

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.

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^® - 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.

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.

BIOBALL^® Video Tutorials

How to use BIOBALL®

Rapid Mycoplasma Testing

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

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.

Performance validation environmental monitoring automation

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. Automatization technologies are more present and improve EM practices.

Testing Bioproduction Samples

This poster presents results from independent studies performed by 4 bioproduction companies using the BIOFIRE® Mycoplasma system that can detect >130 species of mycoplasma. The BIOFIRE® filmarray system condenses all the steps of a conventional PCR test into an enclosed pouch and provides sample to answer in less than one hour with as little as 2 minutes of hands-on time.

Testing Cell Therapy and Bioproduction 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).

Mycoplasma Release Testing Cell and Gene Therapy Product Samples

Testing for mycoplasma contamination is a required release test for Cell & Gene Therapy (CGT) products as specified in the major pharmacopeias(1-3).

Ultra-Rapid Microbial Detection in Cell and Gene Therapy Products

Ultra Rapid Microbial Detection in Cell and Gene Therapy Products

The SCANRDI® is an ultra-rapid alternative technology for detecting microbial contaminants in drug products. Designed to meet compendial testing standards, studies on Limit of Detection (LoD) and Equivalency have been performed with a focus on species listed by the Pharmacopeias microorganisms. The Most Probable Number (MPN) was used to demonstrate that the LoD of the SCANRDI® CELL-BURST is not significantly different from the LoD of a traditional plate counting method on 10 compendial strains.

Mycoplasma release test with low volume protocol: From sample to results in less than 1 hour

Rapid Robust Mycoplasma Detection System for Release Testing of Cell and Gene Therapy Products Containing Mammalian Cells in 1-Hour

Introduce C&GT product specific protocols that allows the inclusion of mammalian cells thus aligning with the upcoming EP guideline (4) whilst providing the required level of detection (≤ 10 CFU/mL) as a Mycoplasma release test.

Recombinant Factor C Characterization Studies Confirm the Published Structure and Function of Manufactured rFC

With the advent of first the EU Pharmacopeial Chapter 2.6.32 (2020) and now the publication of USP Chapter <86> (2024) on the use of recombinant Factor C assays, the manufactured products supplied must meet customer confidence expectations in terms of r-Protein characterization. Both current and historical QC characterization tests are described here for ENDOZYME II. The known and therefore expected structure of the complex molecule is shown below from: Shibata et al. 2018 “Intermolecular autocatalytic activation of serine protease zymogen factor C through an active transition state responding to lipopolysaccharide” (1).

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

Woman in pharamacy checks label on box

Validation Protocol

In the Pharmaceutical industry, Validation protocol and/or Qualification protocol list a set of procedures (tests to be performed) used to check if a product meets the proper requirements of its intended purpose.

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.

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.

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.

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.

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.

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.

Part I : Suitability of a Single Incubation Temperature for Environmental Monitoring Programs

This whitepaper discusses the challenges of one media / one temperature incubation, and evaluates the sustainability of a single incubation temperature for Environmental Monitoring.

Part II : Suitability of a Single Incubation Temperature for Environmental Monitoring Programs

This white paper presents the results and explains the methodology used at Sanofi (Marcy l’Étoile Site - France) to evaluate the suitability of a single incubation temperature for Environmental Monitoring. It 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.

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

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 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.

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

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

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).

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

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.

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.

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 - 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

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.

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

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.

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.

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.

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.

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.