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.

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.

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).

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.