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Pharmaceutical Quality Control Webinars

How to implement single temperature incubation in your EM routine?

WEBINAR

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.
One Hour Mycoplasma Testing

WEBINAR

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.
One Hour Mycoplasma Testing

WEBINAR

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.
Mycoplasma Testing Webinar

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.
BIOBALL® 3-Part Webinar Series

WEBINAR

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.
Reliable and Sustainable Bacterial Endotoxin Testing Webinar

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

503Bs Adopt Strategies to be FDA Audit-Ready

Given the FDA’s growing scrutiny over 503B outsourcing facilities (503B) complying with regulatory requirements, many pharmacies are not only preparing for a potential impromptu visit from the FDA, but also building their company culture as an audit-ready organization.
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WEBINAR

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. While individual challenges may not be unique to cell therapies. The way they can impact cell therapy facilities can be unique with additional considerations given the nature of cell therapy products and production methods.
CBER webinar

WEBINAR

CBER’s Perspective on Implementation of Rapid Microbial Methods

Listen to CAPT Simleen Kaur, Team Leader for Laboratory of Microbiology In-vivo Testing and Standards at FDA Center for Biologics and Evaluation and Research, and Lori Daane, Sr Director of Scientific Affairs at bioMérieux, discuss CBER’s current thinking concerning validation and implementation of rapid microbial methods.

WEBINAR

On Demand: 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 has become essential for manufacturers to ensure productivity. The pressure to reduce the turnaround time has spurred innovation with real-time PCR methods.

WEBINAR

BACT/ALERT® 3D: From Alternative to Routine for Testing Cell and Gene Therapy Products

This on-demand webinar explores rapid sterility testing in Cell and Gene therapy, covering the pivotal role of rapid testing and evolving regulations. Discover why the BACT/ALERT® is the trusted choice for microbial contamination testing and optimize your processes for enhanced quality control and compliance!

WEBINAR

On-Demand: Just in Time Release of CAR T-Cell Therapies During COVID-19

Listen to Irving Ford, Head of Quality at Adaptimmune*, and Lori Daane, Sr Director of Scientific Affairs at bioMérieux, discuss rapid microbial methods like the BACT/ALERT® and the BIOFIRE® Mycoplasma for testing short shelf-life products.

WEBINAR

On-Demand: We are Going Back to the Future With Rapid Methods

Rapid methods have been available to the pharmaceutical industry for decades. Although global regulations have changed to encourage their use (especially for rapid sterility testing) and the compendia have enhanced their chapters to promote the validation and implementation of these technologies, only a handful of firms have embraced rapid methods to their fullest potential.

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

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

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

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

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

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

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

On-Demand: Commercial Cell Therapy Experience Using Mycoplasma Nucleic Acid Testing for Product Release

This webinar will provide a review of validation strategies and implementation for a rapid at-line Mycoplasma test for cell therapy companies.