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 Latest Analytical Techniques in Extractable and Leachables Dr. Tom van Wijk, Abbott Healthcare Products BV In contrast to other impurities the control of extractable and leachables is not well defined yet. Currently guidance is provided e.g. by USP and PQRI... 2 months ago | 70 mins Risk Assessment of Extractables and Leachables... Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals Full title: Risk Assessment of Extractables and Leachables in Different Phases of Development. As the knowledge on the manufacturing process evolves ... 3 months ago | 127 mins Future Trends To Control Risks From Extractables and Leachables Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Kathleen Lava PhD – E&L Expert Nelson Labs Europe Presented by Jason Creasey, Managing Director at Maven E&L Ltd Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independen... 6 months ago | 105 mins ICH Q3E Guidelines and Its Implications Jason Creasey, Managing Director at Maven E&L Ltd and Dries Cardoen at Nelson Laboratories, LLC Presented by Jason Creasey, Managing Director at Maven E&L Ltd Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independen... 4 months ago | 107 mins Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachab Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of Extractables & Leachables at SGS Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachable Risk Assessment Model and Extractable Testing Protocol Presented b... 11 months ago | 88 mins Extractables and Leachables Testing Using a Quality Risk Management Approach Dhaval Tapiawala, Principal Scientist at Pfizer and Dr. Dennis Jenke, Principal Consultant for Nelson Labs Presented by Dhaval Tapiawala, Principal Scientist at Pfizer • Understanding extractables and leachables for better adoption of single use systems • ... 11 months ago | 108 mins Identification of unknown extractables and leachables using mass spectrometry... Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific Full Title: Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence? Extractable and Leachable ... 12 months ago | 57 mins Extractables and Leachables have been used interchangeablely for too long. Are w Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West Pharma Extractables and Leachables have been used interchangeablely for too long. Are we still confused? The terminologies of “Extractable” and “Leachable” ... 2 years ago | 77 mins Assessing the Risk of Interaction Between Extractables and Leachable and Ther... Andrew Teasdale, Senior Principal Scientist at AstraZeneca and Piet Christieans, Phd,Scientific Director at Nelson Labs FULL TITLE: Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins Presented by Andrew Teasdale, Senior Princ... 1 year ago | 94 mins Sanofi’s and SGS’S Implementation of BPOG’S Leachable Risk Assessment model... Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of Extractables & Leachables at SGS Full Title: Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachable Risk Assessment Model and Extractable Testing Protocol ... 2 years ago | 89 mins Identification of unknown extractables and leachables using mass spectrometry... Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific Full Title: Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence? Extractable and Leachable ... 1 year ago | 58 mins Identification of Approaches to Simulated Leachable Studies Jason Creasey, Managing Director at Maven E&L and Karen Pieters, Ir. Team Leader E&L at Nelson Labs Europe Full Title: Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them? Presented by Jason Creasey, Managing Directo... 12 months ago | 80 mins Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materi Ping Wang, Director at Johnson & Johnson and Donald DeCou, E&L Technology Manager at West Pharmaceutical Services Full Title: Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materials Used in Biologics Production Presented by Ping Wang, D... 1 year ago | 79 mins Global Sterile Transportation and Formulation of an Adjuvant Charlotte Masy, Project Manager at GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher Scientific Presented by Charlotte Masy, Project Manager in global support GSK vaccinés Followed by an Industry Perspective presented by Donald Young, Sr. Produc... 11 months ago | 55 mins Identification of Approaches to Simulated Leachable Studies: What are They? W... Jason Creasey, Managing Director at Maven E&L and Karen Pieters, Ir. Team Leader E&L at Nelson Labs Europe Full Title: Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them? Presented by Jason Creasey, Managing Directo... 1 year ago | 81 mins Final Revised Version of BioPhorum Extractable Testing Recommendation Part 1 Frances Sexton, Carsten Worsøe, Ken Wong, and Satish Kumar Mohanvelu Since the first publication of Biophorum (previously known as BPOG) Extractable Testing Recommendation in 2014, the combined team of end-users and sup... 1 year ago | 104 mins Extractables and leachables testing using a Quality Risk Management approach Dhaval Tapiawala, Pfizer and Satish Kumar Mohanvelu Life Sciences Management Professional at MilliporeSigma • Understanding extractables and leachables for better adoption of single use systems • Ensuring safety of drug through determining the level of leach... 3 years ago | 79 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... 11 months ago | 121 mins Extractable Study Design & Data Evaluation of Polymeric Product Contact Material Dr. Ping Wang, Principal Scientist, Janssen R&D & Dr Nixdorf, SGS Group Concerns over the safety and drug product qualities due to extractables and leachables (E&L) from polymeric Product Contact Materials (PCM), especiall... 3 years ago | 74 mins Do Extractable Protocols Truly Help- An End User Perspective Ekta Mahajan, Genentech/Roche Single Use technology is being used more each year in the biotechnology industry. However, extractables and their potential impact on product and pati... 3 years ago | 66 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 Do Extractable Protocols Truly Help- An End User Perspective Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for E & L at Merck KGaA, Darmstadt Germany Presented by Ekta Mahajan, Technical Regulatory Program Director at Genentech Extractables and their perceived impact on product and patients continu... 2 years ago | 48 mins Extractable and Leachable Study Design For Disposables Ken Wong, Jerry Martin and James Hathcock Introduction on what are considered as acceptable extractable and leachable data for submissions. The talk will focus on extractable and leachable stu... 6 years ago | 75 mins Transformation of Toxicology data into Specific PDE’s Kim Li, PhD, DABT, MPH, Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC Presented by Kim Li, PhD, DABT, MPH, Amgen Inc. Followed by an industry perspective presented by Dries Cardoen, Team Leader of Study Directors - Inha... 1 year ago | 92 mins FINDING THE COMMON ROAD TO QUALITY FOR SINGLE-USE MATERIALS Dr Trishna Ray-Chaudhuri, Genentech & Dr Hélène Pora of Pall Biotech | – GMP requirements touch every single use assembly used in clinical studies to commercial manufacturing. The drug product produced in clinical studie... 3 years ago | 64 mins Load more
