Pharma Quality Control On-Demand Webinars

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.

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.

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.

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.

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. 

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.

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.

This webinar/poster explores a new ultra-fast sterility solution for cell and gene therapeutic products.

This webinar/poster explores a new ultra-fast sterility solution for cell and gene therapeutic products.

This webinar/poster explores a new ultra-fast sterility solution for cell and gene therapeutic products.

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.

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.

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.

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

Conventional microbiological methods are established and have been used for detection and identification of microbiological contamination in biological products for decades, but these methods are time consuming and can take several days or weeks to generate results.

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).

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

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. 

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.

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.