Final Revised Version of BioPhorum Extractable Testing Recommendation Part 2
11th June 2020 | 10:00 am EST | Sara Ullsten, R&D Section Manager, Cytiva and Haiyan Hong, R&D manager of Life Sciences at Saint-Gobain |BOOK FREE SEAT FOR THIS WEBINAR
This Webinar is a continuation of Final Revised Version of BioPhorum Extractable Testing Recommendation Part 1
Since the first publication of BioPhorum (previously known as BPOG) Extractable Testing Recommendation in 2014, the combined team of end-users and suppliers has collaborated to examine all improvement opportunities to the original Extractable Testing Recommendation since 2017. During this webinar, the presenters will highlight all the changes to the final revised version of BioPhorum Extractable Testing Recommendation. Specifically, the output of a data review of 26 extractable data sets spanning wide varieties of single use components, which has led to the changes to be made in the original recommendation, will be presented.
The revised extractable testing recommendation will be presented to highlight:
- How to access the final version of the Biophorum Extractable Testing recommendation and example reporting template;
- “Data Sharing Rules of the Road” recommendations for simplifying access to the reports
- Where are the extractable data report flexibilities when using BEDS templates?
To facilitate a harmonized extractable data reporting to end users, the presenters will introduce the newly designed BioPhorum Extractable Data Summary (BEDS) template. Some levels of details with regards to what specific information or format of templates are compulsory and what are flexible for supplier to tailor to their own preferences will be detailed during the webinar. How end users can gain access to these extractable summary reports from suppliers, including subsuppliers, will be addressed.
Additionally, several FAQs questions will be presented to clarify some common questions. The webinars will end with 30 minutes of a panel discussion for participants to seek clarify of all presented information.
Sara Ullsten, R&D Section Manager, Cytiva
Sara Ullsten is R&D Section Manager at Cytiva. She manages the extractables and leachables lab, focused on testing polymeric materials and components used in the manufacturing of biopharmaceutical drug substances and products. She has also experience in extractables testing of medical devices from her position as responsible for the extractables testing program at AstraTech. Sara has 15 years of experience in the Life Sciences’ field and has held several positions in R&D as senior scientist, project manager, lab manager and people leader. Sara has a Doctors’ degree in analytical chemistry from Uppsala University
Haiyan Hong, PhD, R&D manager of Life Sciences at Saint-Gobain
Haiyan Hong, PhD is R&D manager of Life Sciences at Saint-Gobain, which includes responsibility for E&L characterization . Since joining Saint-Gobain in 2015, Haiyan has led extractables project for Saint-Gobain life sciences. Prior to Saint-Gobain, Haiyan served as Senior Scientist at Pall, where she lead project management team for filter and single-use system process-specific validation
Joining as Panelists
James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy, Pall Biotech
James Hathcock, PhD is Senior Director of Regulatory and Validation Strategy at Pall Biotech, which includes responsibility for E&L characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He is an active member of ASTM, ASME-BPE, PDA, ISPE, BPSA, BioPhorum-supplier phorum as well a USP <665> expert panel member. Since joining Pall in 2008, James has led chemical and performance characterization of medical and biotech components, as well as relevant technical packages supporting regulatory filings. Prior to joining Pall, James served as professor of hematology at the Mt. Sinai School of Medicine in New York City, where he directed the protein purification laboratory related to drug characterization and discovery.
Frances Sexton is a TSMS Bioprocess Chemist working in the Materials Management group of Eli Lilly Kinsale, Ireland. Within her role Frances is the subject matter expert (SME) for the biotech drug substance manufacturing E&L approach. She represents Eli Lilly globally on the BioPhorum E&L workstream.
Carsten Worsoe, Principal Scientist, Extractables and Leachables ,Novo Nordisk
Carsten Worsøe has worked with Extractables & Leachables (E&L) for more than 20 years within the pharmaceutical company Novo Nordisk. Within his role at Novo Nordisk Carsten Worsøe has built internal E&L strategies for container closure systems (drug substance and product), production equipment (single use (SUS) and multiple use (MUC)) and devices. Being a quality expert Carsten Worsøe has worked with colleagues in packaging materials, production, devices, analytical, toxicology, formulation and regulatory to perform risk assessments and documentation for E&L testing in development and life cycle management (LCM) projects. That work has involved different administration forms such as inhalation, parenterals (cartridges, vials and prefilled syringes) and solid oral dosage forms and their subsequent production and delivery devices.
In addition to his work at Novo Nordisk Carsten Worsøe is an acknowledged industry expert within E&L and a frequent chairman (15+), advisory committee member (15+) and presenter at various E&L conferences as well as general pharmaceutical conferences (40+). In addition, Carsten Worsøe has held several meetings with health authority persons in regards to E&L. Finally, Carsten Worsøe is an active member of the international E&L working groups; BioProcess Operation (BPOG) Extractables and Leachables Single Use (SUS) and Extractables and Leachables Safety Information Exchange (ELSIE). Within ELSIE Carsten is a member of the executive committee, as well as the leachables and ICH subteams.
Ken Wong, Deputy Director at Sanofi Pasteur
Ken Wong is a Deputy Director of Process Technology Platform at Sanofi Pasteur. Serving as the Swiftwater site extractables and leachables (E&L) SME but also provide E&L supports to all global sites. His 19-year in biopharma professional career has ranged from R&D to development and commercialization to cGMP manufacturing support. For the last 17 years, he has specialized in E&L in wide range of packaging systems (including lyophilized powders, oral liquids, creams, ophthalmic solutions, transdermal, bio-surgical delivery systems, injectable devices, and inhalation devices for aerosol, solutions and powders). In the last 10 years, he has been heavily involved with Single-Use Technology and actively participating in Disposable workstreams of BioPhorum Operations Group (BPOG), the USP <665> Expert Panel and the ELSIE material working group.
Satish Kumar Mohanvelu – Senior Marketing Manager Emprove® Program, Merck
Satish Kumar Mohanvelu – Senior Marketing Manager Emprove® Program, Millipore Sigma, based at Bedford, Massachusetts, USA.
Responsible for implementing the Emprove® Program with a specific focus on Filtration and Single Use Portfolio of Products. Through this program comprehensive product documentation in the form of dossiers are created to support Biopharmaceutical customers globally.
Satish is a Postgraduate in Biochemistry with about 20 years of experience in the Biopharmaceutical Industry. He has held various positions within the organization with significant time spent in the past managing the Filter Validation Services and laboratories.