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.

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.

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 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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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