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 Single Use Process for Production of AAV Gene Therapy Products Lance Marquardt, Associate Director -Upstream Processing Gene Therapy, Hopewell Biologics Manufacturing at PTC Therapeutics An overview of single use manufacturing for the production of AAV gene therapy products with comparisons to traditional monoclonal antibody production... May 26, 2022 2:00pm Sanofi’s Journey & Strategy for Continuous Processing for Small Molecules Flavien Susanne at Sanofi and Sean Bermingham at PSE Ltd In the past decade, there has been a growing interest in the application of continuous processing in the pharmaceutical industry with 100s millions of... 4 months ago | 117 mins In-line monitoring of surfactant clearance... Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur Full Title: In-line monitoring of surfactant clearance in viral vaccine downstream processing February 15, 2022 3:00pm The Business Benefits of PAT in Continuous Drug Product Manufacturing Steve Hammond, Independent Consultant at Steve Hammond Consulting It is well recognized that continuous processing requires continuous monitoring, at the “heart-beat” of the process to ensure product quality and pati... 4 months ago | 64 mins Improving Efficiency in Upstream Process Development Jackie Gonzalez, Senior Upstream Development Engineer at Takeda, Klaus Mauch, CEO at Insilico Biotechnology AG The time required to develop and produce a new molecule and put it in the hands of patients is an important consideration in the drug development proc... 11 months ago | 113 mins Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT... Dejan Arzenšek, at Novartis and Justin Moretto at Kaiser Optical Systems, Inc. Full Title: Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT Advanced Analytical Technologies to Monitor Critical Quality... 5 months ago | 117 mins Advances in the Purification of Antisense Oligonucleotides Robert Gronke, Ph.D., Senior Principal Scientist, at Biogen and John Cyganowski, Director of Customer Application, Merck Following on the commercial success of Spinraza® (the first successful treatment for patients with spinal muscular atrophy), antisense oligonucleotide... 3 months ago | 61 mins Designer Sterile Filtration in Aseptic Processing Using Single Use Technology Alan Kelly, Project Engineer at Sanofi and Terri Love, Senior BioManufacturing at Merck Alan Kelly is a Project Engineer who has been employed within the pharma/biopharma industry in Ireland for the past 25 years and is currently in his 1... 1 year ago | 94 mins Manufacturing in the Industry 4.0 era... Christos Varsakelis at GlaxoSmithKline Biologicals SA & Mark Demesmaeker, at Sartorius & Roger-Marc Nicoud at Ypso-Facto Full Title: Manufacturing in the Industry 4.0 era: how to balance innovation with performance while not being disrupted The manufacturing status quo ... 11 months ago | 112 mins Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing Aaron Mack, Engineer at Biogen & Dave Kolwyck, Director at Biogen and David Gemmell Senior Process Engineer at Merck Presented by Aaron Mack, Engineer at Biogen This talk will focus on the risk based approach that Biogen used for determining which raw materials to i... 2 years ago | 83 mins Cost Considerations for the Application of Continuous Processing Narasimha Rao Nedunuri, CEO of CLONZ Biotech and Tania Pereira Chilima, Product Manager at Univercells Cost contribution of continuous manufacturing both in operational and capital expenditure in Monoclonal antibody production. Evaluating cost of produc... 2 years ago | 63 mins FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa... Dr Lily Koo, Consumer Safety Officer at FDA and Dr Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing Presented by Dr Lily Koo, Consumer Safety Officer at Food and Dru... 1 year ago | 82 mins FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa... Dr Lily Koo, Consumer Safety Officer at FDA and Dr Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing Presented by Dr Lily Koo, Consumer Safety Officer at Food and Dr... 2 years ago | 83 mins Janssen's Real Time release: Using MSPC to enhance batch release. Sarah Nielsen, at Janssen and Herman He, at Thermo Fisher Scientific The Janssen real time release strategy will be presented. Multivariate statistical process modeling is used as a way to guide batch release (either vi... 4 months ago | 80 mins Case Study: Biomanufacturing for Tomorrow Marc Pompiati, Principal Scientist at Roche Diagnostics GmbH ·Gain insight of a combined USP/DSP line (SUB + 1. column) using disposables and automated systems, and a connected process ·Uncover the link from ea... 1 year ago | 52 mins Single Use Manufacturing within the Bristol-Myers Squibb Manufacturing Network Lance Marquardt, Bristol-Myers Squibb & Sara Bell, Merck By Lance Marquardt, Associate Director – Upstream Processing for Hopewell Clinical Manufacturing at Bristol-Myers Squibb and Sara Bell, Senior Marketi... 3 years ago | 66 mins CONTINUOUS MANUFACTURING OF BIOLOGICS: A JOURNEY FROM CONCEPT TO REALITY Himanshu Gadgil at Enzene Biosciences Ltd and Ganesh Kumar, at Sartorius Full Title: Opportunities and Challenges in Developing a Fully-Connected Continuous Manufacturing Process for Biologics Insights through case studies... 4 months ago | 113 mins Janssen CM-strategy: A Story of Multiple Platforms From R&D to Commercial Presented by Jeroen Geens, Engineering Technical Director at Janssen Research & Development After initial CM projects and successes for specific compounds in its commercial portfolio, Janssen defined in 2015 a vision to make continuous manufa... 1 year ago | 103 mins Cost Considerations for the Application of Continuous Processing Narasimha Rao Nedunuri, CEO of CLONZ Biotech and Tania Pereira Chilima, Product Manager at Univercells Cost contribution of continuous manufacturing both in operational and capital expenditure in Monoclonal antibody production. Evaluating cost of produc... 1 year ago | 62 mins Continuous Capture and Continuous Recovery - Novel Ideas for Product Recovery.. Kerstin Lange, Andrew Falconbridge at Alvotech and Earl Pineda Sr. Manager, Upstream Field Applications EU/APAC from Repligen Alvotech developed an intensified fed-batch process using a cell retention device for the production of a complex fusion protein. The process uses the... 12 months ago | 89 mins Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial... Dan Hill, Manufacturing Scientist at Biogen and Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc. The use of in-line Raman spectroscopy as an in-line process analytical technology (PAT), in the biotechnology industry, has matured over the past deca... 2 years ago | 90 mins Managing Biologics Process Analytical Technology in Pfizer Keith Davis, Principle Scientist at Pfizer Coordinating PAT between development and manufacturing organizations is always challenging. When there are multiple development sites and numerous man... 3 years ago | 21 mins Extractables from Single-Use Bioreactors and Impact on Cell Culture Performance Yasser Nashed-Samuel, Principal Scientist at Amgen Donald Young, Sr. Product Manager at Thermo Fisher Scientific Attribute Sciences, Process Development, Amgen Biopharmaceuticals are drugs manufactured bygrowing genetically engineered cells in bioreactors to prod... 3 years ago | 64 mins Application of USP 665 data to support qualification of single use systems Ken Wong of Sanofi Pasteur, Desmond G. Hunt, of USP and James Hathcock of Pall Biotech Application of USP 665 data to support qualification of single use systems Presented by Ken Wong, Desmond G. Hunt and James Hathcock This talk will... 1 year ago | 121 mins Characterization of Biotherapeutics Diane McCarthy, PhD, Senior Scientific Liaison, US Pharmacopeia and Kai Scheffler Product Manager at Thermo Fisher Scientific By Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia Biotherapeutic products are typically characterized by multiple ... 2 years ago | 76 mins Load more
