The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
"Many of the benefits of continuous manufacturing increase when you go end-to-end" ~ Richard Braatz, PhD, Edwin R. Gilliland Professor of Chemical Engineering, Novartis-MIT Center for Continuous Manufacturing
"We believe existing guidance & regulations are adaptable to continuous manufacturing" ~ David Doleski, Deputy Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ
"3 key advantages to a CM business case: development, tech transfer & commercial production" ~ Lawrence De Belder, Senior Principal Engineer, Johnson & Johnson, Belgium
"FDA supports continuous processing for pharmaceutical manufacturing" ~ David Doleski, Deputy Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ
"Continuous manufacturing is one of the steps towards reliable drug quality, benefits patients and industry" ~ Rapti Madurawe, PhD, Division Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ, Conference Co-Chair
"While there are no guidelines specific to continuous manufacturing in Europe, continuous manufacturing fits well with existing EMA guidelines" ~ Dolores Hernan Perez de la Ossa, PhD, Quality Specialist, Regulatory/Human Medicines/Scientific Advice and Protocol Assistance, EMA, United Kingdom
"Pre-approval inspection decision made based on product, process, and facility risk" ~ David Doleski, Deputy Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ
"Data integrity important even in a high-tech environment" ~ Speaker at 2016 Continuous Manufacturing Conference
"Process for reviewing batch records will be compressed for continuous manufacturing" ~ Speaker at 2016 Continuous Manufacturing Conference
"Traceability is important, especially for different segments of a production run" ~ David Doleski, Deputy Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ
"Early dialogue with FDA, EMA is recommended" ~ Speaker at 2016 Continuous Manufacturing Conference
The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...