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Pharmaceutical Quality Control On-Demand Webinars

WEBINAR

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

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

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

On-Demand: BACT/ALERT® 3D

Listen to Lori Daane, Sr. Director of Scientific Affairs at bioMérieux, discuss rapid sterility testing within the cell and gene therapy landscape. She discusses the evolving regulations and why the BACT/ALERT® has continued to be the go-to instrument of choice for testing these products for microbial contamination.
WEBINAR

High Throughput Endotoxin Testing

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

Mycoplasma Testing

The standard test for mycoplasma contamination is evolving. As macromolecule drugs derived from mammalian cells become more commonplace, reducing the turnaround time for testing and investigation on the large-scale bioreactors of today has become an indispensable need for manufacturers to ensure productivity and cost competency. The pressure to reduce the turnaround time has spurred innovation with real-time PCR methods. The vision for future testing is simple to use, fast and accurate.
WEBINAR

BIOBALL® Webinar Part 3

In this webinar, Dr Megha Bajaj will review the trends seen in the Industry regarding the selection criteria used for including these in-house strains. Stephen Gleeson, Business Development, will share his experience of the process that sites in Ireland have used regarding their environmental monitoring trends, risk assessment, in-house isolates selection and experiences of the BIOBALL® service.
WEBINAR

Endotoxin Detection as Needed, When Needed

A novel flexible, scalable and sustainable Endotoxin assay. Microplate based endotoxin testing can be efficient and convenient when testing full plates, but this is not always the case.
WEBINAR

BIOBALL® Webinar Part 2

Guest speaker Dr. Tony Cundell presents on objectionable organisms and the exclusion of Burkholderia Cepacia Complex members from aqueous non-sterile drug products. This will be followed by Dr Megha Bajaj presenting on BIOBALL® applications in non-sterile product testing methods.
WEBINAR

Implementation of Advanced QC Testing Solutions

During this tutorial, industry experts highlight needs and challenges for advancing QC testing for Cell &Gene Therapies manufacturing. The first presentation is dedicated to microbial contamination control and testing strategies for just in time release of CAR T products. The second presentation is focusing on novel strategies for phenotypic cell analysis in cell therapy.
WEBINAR

Value of QC Testing in ATMP

In this webinar, you’ll learn more about: • Improving the time to result of QC testing with rapid and automated solutions to reduce patient to patient time • Advance safety testing of ATMP from raw materials to product release • Bringing flow cytometry analysis to point-of-need
WEBINAR

Chemical Risks Management in Product Development

Chemical risk is omnipresent and a major concern for European authorities. Whatever the industrial activity, chemical risk management must be an integral part of the development of products placed on the market. How does bioMérieux, a manufacturer of microbiological analytical solutions, anticipate and integrate regulatory changes in the development of its new products?
WEBINAR

BIOBALL® Webinar Part 1

What are the learning objectives? Best practices, trouble-shooting, how to never lose a dose. Who is your speaker? Dr Megha Bajaj, Global Solutions Manager, bioMérieux Sydney, Australia. Who should attend? Anyone interested in using BIOBALL® and anyone currently using BIOBALL®.
WEBINAR

The Truth and Fallacies of Recombinant Endotoxin Assays

The comparability and equivalence of recombinant Factor C (rFC) to LAL has been proven with over 10 peer-reviewed studies by government and pharmaceutical facilities. Some articles and papers with limited scientific proof have been recently published, attempting to raise doubt with users and authorities regarding the use of these recombinant methods. Because science matters, we invite you to participate in this webinar series to take a look at the truths and fallacies of recombinant endotoxin assays. Our experts will be happy to answer your questions.
WEBINAR

Faster Development & Quicker Release

Discover how to optimize your cosmetic products’ development and speed up your release. Shorten your product development cycle and increase flexibility focusing on quick microbiological analysis results for cosmetics products, will help you to release safer products faster on the market. With a reduction in time-to-results as well as cutting work time by half, your business can remain financially healthy.
WEBINAR

Value of the QC Testing in ATMP

OVERVIEW - Cell an Gene Therapy Market: Specific needs and challenges - Traditional Sterility Test and the automated growth based methods: The BACT/ALERT 3D Dual-T technology - Quality cellular attributes and the Accellix solution
WEBINAR

Overcoming LER

The phenomenon of low endotoxin recovery (LER) has gained renewed attention in the scientific community in recent years, as the FDA requires that all new BLAs are able to successfully unmask endotoxin if LER occurs. In this webinar, endotoxin experts demystify LER and discuss a “toolbox” for effective endotoxin detection.
WEBINAR

Mycoplasma Testing

For nearly 30 years, mycoplasma testing for biologics has been performed using cell culture-based methods. The compendial mycoplasma detection method has been the gold standard in the biopharma industry. Its high sensitivity (0.1 CFU/mL detection) is achieved through multiple subcultures and observations of culture media and agar plates over the course of 28 days.
WEBINAR

How NEW ANNEX 1 Could Help in CCS

How NEW ANNEX 1 could help in CCS - Contamination Control Strategy & better microbiological control bioMérieux is pleased to invite you to participate in the upcoming PHARMA webinar. During the webinar, new regulations on microbiological control of processes and production will be presented. Participation in the webinar is free of charge.
WEBINAR

The Hunt for LPS

OVERVIEW • LPS can elicit a severe response in the immune system and severe reactions to bacterial endotoxins can be fatal. As a result, there are strict regulations for the acceptable levels of endotoxin contamination in medical devices and pharmaceuticals. • Learn how our comprehensive services with a special expertise in Low Endotoxin Recovery can help detect endotoxin contamination.
WEBINAR

Evolution of an Automated Rapid Microbial Testing Technology

Dr. Lori Daane will discuss the evolution of an automated rapid microbial detection technology to meet pharmaceutical industry needs, including how a specialized culture medium and temperature combination might optimize fungal detection.
WEBINAR

Evaluation of Large Volume Delayed Sampling and Pathogen Reduction Technology Strategies

Large volume delayed sampling (LVDS) and pathogen reduction technology (PRT) are two strategies for platelet processing to control risk of contamination prior to transfusion. LVDS and PRT have different processing methods, risks, and impact on platelet shelf life that can affect platelet costs and availability to the healthcare system.
WEBINAR

The Effect of Β-Glucans on LAL Activity in Pre-Treatment Water

The efficacy of recombinant Factor C (rFC) for bacterial endotoxin testing (BET) has been proven with multiple peer-reviewed papers comparing rFC with LAL. Non peer-reviewed data has been circulating looking at the Limulus amebocyte lysate (LAL) and rFC reactivity of pre-treatment deionized water.
WEBINAR

Reliable and Sustainable Bacterial Endotoxin Testing

This webinar will introduce the concept and relevance of bacterial endotoxin, along with a review of established detection methods. Dr Reich will discuss the emergence of recombinant Factor C (rFC) as a consistent and sustainable basis for endotoxin testing, the principles of its use, and performance of endotoxin tests based on rFC in comparison with tests based on limulus amoebocyte lysate (LAL).
WEBINAR

Bioproduction and Process Efficiency

Whilst so many of us are experiencing new challenges with COVID-19 all around the world, we thought it would be an ideal moment for sharing scientific, technical and regulatory knowledge. bioMérieux is committed to delivering rapid solutions for improving your process efficiency and maintaining the compliance until the final product release.
WEBINAR

Rapid Sterility Testing

Gene and cell therapy products, also known as advanced therapy medicinal products (ATMP), present unique challenges for Quality Control release testing due to their very short shelf life, fast medical need for dosing patients, and limited availability of product for sterility testing. As such, meeting the requirements for existing compendial sterility test methods is often difficult, if not impossible, to achieve.
WEBINAR

Advancing QC Testing for Cell and Gene Therapy Products

The successful development and commercialization of Cell and Gene Therapy products opened a hope for patients with urgent medical needs and opened a door for a new era of modern medicine. However, the manufacturing of C&GT products is very complex and they have to be released in a short timeframe. These are high value products, available in limited quantity that should be controlled employing complex set of tests in order to ensure identity, safety and potency.
WEBINAR

Focus on Endotoxin and rFC Testing vs. ANNEX 1

Focus on Endotoxin and rFC testing vs. ANNEX 1: Session 2
WEBINAR

Focus on Rapid Methods and Identification vs. ANNEX 1

Focus on Rapid Methods and Identification vs. ANNEX 1 I Updates
WEBINAR

Focus on Environmental Monitoring vs. ANNEX 1

Viable and non-viable environmental and process monitoring: The guidance here applies to ongoing routine monitoring with regards to the design of systems and setting of action limits alert levels and reviewing trend data. The section also gives guidance on the requirements of Aseptic Process Simulation (APS).
WEBINAR

Overview of ANNEX 1

Overview of ANNEX 1 modifications and impacts.
WEBINAR

Burkholderia cepacia Complex 

Dr Cundell will introduce the pharmaceutical industry concept of an objectionable organism, along with Burkholderia cepacia complex (BCC) and its leading position amongst objectionable organisms. He will also review some remarkable examples of B.cepacia contamination of non-sterile pharmaceuticals, and the consequences that befell some companies and the consumers of their products.
WEBINAR

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.
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.
WEBINAR

Achieving Data Integrity With Automated ID Systems

Our presenter explains current pharmaceutical industry conceptions of Data Integrity and risks associated with poor data integrity practices, and examines how automated systems can help improve data integrity.
WEBINAR

Rapid Sterility Testing for Short-Life Pharmaceuticals

Dr. Tony Cundell has co-chaired the USP Expert Panel that published a draft guidance document USP-1071 concerning Rapid Sterility Testing of Short-Life Products: A Risk-Based Approach. This document follows publication in late 2017 of a stimuli article The Development of Compendial Rapid Sterility Tests.
WEBINAR

Enhancing Platelet Screening for Bacterial Contamination

Dr Ramirez-Arcos reviews an improved bacterial testing algorithm for platelets at Canadian Blood Services. Outcomes include improved sensitivity of the platelet concentrate screening protocol for bacterial contamination observed after implementation of the 7-day platelet concentrate shelf life, and increased detection of contaminated buffy coat pools and apheresis units by approximately 8x and 2.7x, respectively, mostly with anaerobic bacteria.
WEBINAR

ENDOZYME II GO as a Rapid Endotoxin Test

Kevin Williams discusses rapid endotoxin testing methods, including the merits of recombinant Factor C.
WEBINAR

Endotoxin Testing Using Recombinant Horseshoe Crab Factor C (rFC)

Are you interested to understand the use, applications and approval process of sustainable rFC tests for endotoxin? Then view this complimentary webinar addressing the benefits advanced rFC assays offer, including consistency of results and increased lab efficiency.
WEBINAR

Development of R2A 3P Media and Evaluation of Automated Water Testing

This presentation explores development of water testing media, including advantages of use of automated incubation and enumeration technology.