LONDON, November 7, 2018 /PRNewswire/ --
BioPharma Asia leading b2b biopharma and pharmaceuticals publication announces free live webinar on Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release to take place on November 8th at 10:00 EDT. To attend click here: https://biopharma-asia.com/webinars/regulatory-approval-of-three-rapid-microbiological-methods-for-maci-product-release/
John Duguid who is the Senior Director for Research & Development at Vericel Corporation will present on why rapid detection of contaminants is essential for cell therapy products with short shelf lives. Integrating quality into the process through lot segregation, raw material qualification, environmental control, personnel training, and detailed procedures is critical because final results for conventional microbiological tests may not be available prior to product release or patient administration. EMA approval of the MACI MAA in 2013 followed by US FDA BLA approval in 2016 included three RMM product release assays for sterility, endotoxin, and mycoplasma.
Also joining the webinar will be Dr Nicola Reid who is the Senior Product Manager at Charles River - Microbial Solutions, who will do a follow up presentation on Data Integrity: Eliminating Risk & Human Error by Utilising Cartridge Technology. Dr Reid will present on how the human element can never be completely eliminated in Bacterial Endotoxin Testing, but she will be discussing what can be done to mitigate the risk for human error and how it relates to the data integrity problem? She will also discuss reducing the risk for human error in our manufacturing and laboratory processes will ensure that we comply with data integrity laws and regulations while building quality into our everyday processes and thus keeping our patients and our drugs safe. As laboratory testing shifts from observation-based qualitative methods to more objective quantitative methods, focus on data integrity becomes more critical to ensure overall product quality and patient safety.
Dr Reid will apply these principal to an invalid BET example to see how the result can potentially cripple your manufacturing timelines. There's no mistake that the LAL assay is the gold standard for endotoxin testing, and advances in science have allowed for improvement in how it's utilized. The end result is the revolutionary cartridge technology. Endosafe® cartridge technology is the innovative response to the customers' need for higher sensitivity and faster quantitative results. Designed to optimize and refine the use of LAL, the cartridge technology eliminates a significant amount of the raw material and accessories required for traditional LAL methods while reducing time-consuming preparation and technician variability
About Vericel
Vericel develops, manufactures, and markets autologous cell-based therapies for patients with serious diseases and conditions. The company markets two cell therapy products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is a third generation autologous cellularized scaffold product that is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.
About Charles River Laboratories
For 30 years, Charles River has been dedicated to the development of precise, robust micro QC solutions that help bring your products to market safely and efficiently. Our mission is to provide industry-leading scientific and technological advances that not only meet ever-changing regulatory guidelines, but set a new standard in the way you perform testing. We've purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant and measurable data to fuel confident decisions on product quality for release. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture and protects your reputation.
About BioPharma Asia
BioPharma Asia is a leading b2b biopharma and pharmaceuticals publication. It specialises in keeping its readers informed through technical articles, and webinars written and presented by the end user Biopharma and Pharma industry for the Biopharma and Pharma industry. For more information please visit www.Biopharma-Asia.com
Media Contact Information: Stephen Edwards Phone: +44-203-440-7108 Email: [email protected]
Website: www.Biopharma-Asia.com
SOURCE BioPharma Asia
Advertisement
BioPharma Asia leading b2b biopharma and pharmaceuticals publication announces free live webinar on Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release to take place on November 8th at 10:00 EDT. To attend click here: https://biopharma-asia.com/webinars/regulatory-approval-of-three-rapid-microbiological-methods-for-maci-product-release/
Advertisement
John Duguid who is the Senior Director for Research & Development at Vericel Corporation will present on why rapid detection of contaminants is essential for cell therapy products with short shelf lives. Integrating quality into the process through lot segregation, raw material qualification, environmental control, personnel training, and detailed procedures is critical because final results for conventional microbiological tests may not be available prior to product release or patient administration. EMA approval of the MACI MAA in 2013 followed by US FDA BLA approval in 2016 included three RMM product release assays for sterility, endotoxin, and mycoplasma.
Also joining the webinar will be Dr Nicola Reid who is the Senior Product Manager at Charles River - Microbial Solutions, who will do a follow up presentation on Data Integrity: Eliminating Risk & Human Error by Utilising Cartridge Technology. Dr Reid will present on how the human element can never be completely eliminated in Bacterial Endotoxin Testing, but she will be discussing what can be done to mitigate the risk for human error and how it relates to the data integrity problem? She will also discuss reducing the risk for human error in our manufacturing and laboratory processes will ensure that we comply with data integrity laws and regulations while building quality into our everyday processes and thus keeping our patients and our drugs safe. As laboratory testing shifts from observation-based qualitative methods to more objective quantitative methods, focus on data integrity becomes more critical to ensure overall product quality and patient safety.
Dr Reid will apply these principal to an invalid BET example to see how the result can potentially cripple your manufacturing timelines. There's no mistake that the LAL assay is the gold standard for endotoxin testing, and advances in science have allowed for improvement in how it's utilized. The end result is the revolutionary cartridge technology. Endosafe® cartridge technology is the innovative response to the customers' need for higher sensitivity and faster quantitative results. Designed to optimize and refine the use of LAL, the cartridge technology eliminates a significant amount of the raw material and accessories required for traditional LAL methods while reducing time-consuming preparation and technician variability
About Vericel
Vericel develops, manufactures, and markets autologous cell-based therapies for patients with serious diseases and conditions. The company markets two cell therapy products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is a third generation autologous cellularized scaffold product that is indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the adult knee, with or without bone involvement. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.
About Charles River Laboratories
For 30 years, Charles River has been dedicated to the development of precise, robust micro QC solutions that help bring your products to market safely and efficiently. Our mission is to provide industry-leading scientific and technological advances that not only meet ever-changing regulatory guidelines, but set a new standard in the way you perform testing. We've purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant and measurable data to fuel confident decisions on product quality for release. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture and protects your reputation.
About BioPharma Asia
BioPharma Asia is a leading b2b biopharma and pharmaceuticals publication. It specialises in keeping its readers informed through technical articles, and webinars written and presented by the end user Biopharma and Pharma industry for the Biopharma and Pharma industry. For more information please visit www.Biopharma-Asia.com
Media Contact Information: Stephen Edwards Phone: +44-203-440-7108 Email: [email protected]
Website: www.Biopharma-Asia.com
SOURCE BioPharma Asia
