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... 4 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 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 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 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 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 ... 10 months ago | 112 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 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 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 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 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 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 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 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 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 Quality-By-Design in Spray Drying Processes - Transfer Lab to Production Sune Klint Andersen, Janssen Pharmaceutica & João Vicente Senior Scientist - Particle Engineering Team Leader at Hovione Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous natur... 3 years ago | 77 mins DSF and FTIR as methods for the identification and characterization Marina Kirkitadze , Deputy Director, Head of Biophysics & Conformation Unit, Analytical R&D Biochemist & Kristen Kalbfleisch The focus of this presentation is the application of Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Fluorimetry (DSF) method... 3 years ago | 71 mins SUS Leachable Testing: Leachable Study Design for Single-Use Components Kathryn McGohan The BPOG Leachables Working Group has recently published a Best Practice Guide for Leachables. The Best Practice Guide was developed to help Biopharma... 4 years ago | 69 mins Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective Dr Li Zang, Dr Chongfeng Xu and Dr Stephen Tate Common mammalian cell lines used for biopharmaceutical production include Chinese Hamster Ovary (CHO), NS0 and Human Embryonic Kidney (HEK) cells. Eac... 4 years ago | 60 mins Host Cell Protein Characterisation and Mass Spectrometry Strategies Xuezhi Bi, Group Leader (Proteomics) /Senior Scientist, Bioprocessing Technology Institute, A*STAR Adding Mass Spectrometry as part of the host cell protein workflow Analytical Strategies in HCP identification and purification process Developing Qua... 3 years ago | 37 mins Load more
