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Webinars

View a selection of webinars discussion the latest news and trends in Pharmaceutical Quality Control.

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.

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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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.

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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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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.

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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.

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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

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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).

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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.

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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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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.

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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.

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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.

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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.