Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control... Presented by Dr. Zlatibor Velickovic PhD at Royal Prince Alfred Hospital and Alan Hoffmeister at Charles River Laboratories Full Title: Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control & Benefits of Cartridge Technology During manufacture of CAR... 1 month ago | 115 mins Points To Consider: Demonstrating Comparability Between Recombinant... Karen Zink McCullough at MMI Associates, Nicola Reid at Charles River Labs and Veronika Wills, At Associates of Cape Cod, Inc Full Title: Points To Consider: Demonstrating Comparability Between Recombinant and Lysate Reagent For BET Testing 3 months ago | 123 mins A Comprehensive Approach to Assess the Impact of Microbial Impurities on Pat... Dr Friedrich von Wintzingerode, QC Lead iNeST Project at Roche and Shabnam Solati, CEO & Co-Founder at CTL-MAT FULL TITLE: A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics Presented by Dr ... 1 year ago | 80 mins Current Bacterial Endotoxins Test (BET) and its Intended Use Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Veronika Wills, Manager, Technical Services Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Veronika Wills, Manager, Technical Services The Bacterial Endot... 1 year ago | 110 mins Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay Ruth Daniels, Senior Scientist, Microbiology Expert, Janssen and Kevin Williams Microbiological Test Development, bioMérieux Presented by Dr. Ruth Daniels, Senior Scientist - Microbiology Expert at Janssen This webinar presentation will discuss: • Endotoxin hold time studi... 1 year ago | 68 mins New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical... Presented by Friedrich von Wintzingerode Global QC at Roche Followed by Mathilde Arnault, Research Scientist at Merck KGaA, Full Title: New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical Manufacturing Process Large scale Production of Biologics is s... 3 years ago | 62 mins PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Ro Since first reported by Chen and Vinther in 2013, the phenomenon known as low endotoxin recovery (LER) has been broadly observed in certain matrices c... 3 years ago | 71 mins Regulatory Approval of Three Rapid Microbiological Methods for MACI Release John Duguid, Senior Director, at Vericel Corporation in Cambridge, and Nicola Reid, Senior Product Manager at Charles River Title:Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release Rapid detection of contaminants is essential for cell therap... 3 years ago | 65 mins End User Perspective on Setting in-Process in Endotoxin Limits Dr Friedrich von Wintzingerode, Roche/Genentech There is a lack of detailed guidance for setting endotoxin in process limits (alert levels and action limits) for biologics. This webinar will present... 4 years ago | 41 mins Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test Karen Zink McCullough of MMI Associates & Kevin L. Williams of BioMérieux Title: Preview of USP’s Informational Chapter, Guidelines on the Endotoxins Test Presenter: Karen Zink McCullough, MMI Associates The retirement of FD... 3 years ago | 61 mins Controlling variability to increase accuracy in the BET Assay Karen McCullough and Alan Baines Karen McCullough’s presentation will look at the many sources of variability in the Bacterial Endotoxins Test. While a certain level of variability is... 9 years ago | 51 mins
