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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!

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Solving the Endotoxin Detection Challenge for Difficult Samples

In the pharmaceutical industry, customers dealing with challenging products, particularly those in the cell and gene therapy sector, confront unique hurdles when it comes to ensuring product safety. This article explores the unique challenges faced by these customers in endotoxin testing and introduces our innovative solutions to address these challenges.

Low Endotoxin Recovery (LER) and Biologic Drugs

Lets explore the critical importance of understanding endotoxin masking phenomenon and overcoming the Low Endotoxin Recovery (LER) challenges. In this article you’ll learn how innovative detection methods and protocols like Hold Time Studies (HTS) can help manufacturers enhance product safety and quality standards.

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).

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.

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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.

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.

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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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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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?

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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 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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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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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.

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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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.

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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.

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.

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.

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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.

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.

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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.

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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).

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.

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.

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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.

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.

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 - 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.

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.

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.

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.

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 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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

Endotoxin Testing: New Horizons with Recombinant Reagents

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

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.

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.

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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.

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).

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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.

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.

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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.

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.

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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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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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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.

Data Integrity Management and Risk Mitigation Made Simple

The standards for proving data integrity have gotten stricter. Today, regulatory organizations from all over the world, such as the FDA, EMA, and PDMA, conduct audits more frequently, in a more extensive way, and observations are becoming more frequent. They demand that data is accurate and reliable. It’s in the best interest of pharmaceutical companies to design flexible and risk-based strategies to ensure data integrity.

Embrace rFC for Lab Transformation

Endotoxin detection is not just a regulatory requirement; it's a critical factor in ensuring pharmaceutical safety. It's time to discover the transformative power of Recombinant Factor C (rFC) and its journey from being an alternative assay to becoming a compendial method.

Champion Sustainability: The 3R Revolution in Endotoxin Testing

The 3Rs principle has resonated with the pharmaceutical industry as an ethical warrant of animal welfare since 1959. It is increasingly associated with the so-called 3Rs initiatives related to larger sustainability initiatives such as reducing waste and reusing and recycling resources and products. Those new 3Rs were agreed upon at the G8 Sea Island Summit in June 2004 as a new G8 initiative. The use of rFC meets several criteria of the 3Rs, including conservation, supply chain assurance, waste reduction, and animal welfare as well as a platform for test modernization.

Discover the Future of Endotoxin Detection with rFC and USP Chapter <86>

Endotoxin detection has long been reliant on the Limulus Amebocyte Lysate (LAL) method. The endotoxin detection landscape is evolving with the pending adoption of USP Chapter <86>. As LAL once eliminated the need for the rabbit test for the sake of scientific utility, recombinant Factor C (rFC) is becoming the new endotoxin test standard.

eBook: Your Quick Guide To Better Endotoxin Testing

Most new users of Limulus-based tests want to review basic knowledge around endotoxin and endotoxin detection, while more experienced users want to review the practical aspects of testing with an eye toward meeting ever-changing regulatory expectations. They also want to generate laboratory dialog as to how to apply basic principles and “best practices” to increasingly complex tasks including method development, verification, validation and the routine testing of various drug types. This material can also serve as a supplement to a user’s basic endotoxin training.

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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.

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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.

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).

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

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

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

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.

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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 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.

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.

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.

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.

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.

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Webinar 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.

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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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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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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.

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.

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.

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.

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.

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.

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!

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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.

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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.

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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.

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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.