Case Study and Experience on Sanofi’s and SGS’s Implementation of BPOG’s Leachable Risk Assessment Model
10th September 2019 | 10:00 am EST | Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGS |WATCH FOR FREE
Brief review of the BPOG’s Leachable Risk Ranking model. A case study of the leachable risk model implementation into Sanofi will be presented. All changes to specific risk factors and weights changes will be discussed. Finally, the lesson learns and experiences of the risk model performances on several projects will be shared.
Presented by 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.
Followed by Case Study and Experience in Extractables and Leachable Studies of Plastic Process Materials – a CRO perspective
Extractables and leachables (E&L) from the plastic process materials used during pharmaceutical and biopharmaceutical manufacturing can potentially pose risks to the safety, efficacy, and stability of pharmaceutical and biopharmaceutical products.
The USP risk assessment model will be briefly reviewed. Challenges regarding design of extractions and analytical evaluation threshold (AET) calculation for process materials will be discussed. A few case studies regarding the E&L studies of process materials will be shared.
Presented by Dujuan Lu, Manager/Global Lead Extractables & Leachables at SGS Life Sciences
Dr. Dujuan Lu has been leading the extractable and leachables (E&L) team at SGS Fairfield New Jersey site since 2015 and leading SGS global E&L program with E&L centres in Asia and Europe since 2017. She has extensive pharmaceutical industry experience with more than 200 E&L studies on a broad range of packaging systems, including process equipment (SUS, MUS, etc), pharmaceutical finished packaging and medical device. Before joining SGS, she was working at Fresenius Kabi, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has more than 10 years of experience on trace analysis by LC/MS and GC/MS.
Dr. Dujuan Lu obtained her PhD in analytical chemistry from the University of Pittsburgh. She has authored more than 10 peer-reviewed journal publications with more than 300 citations. She has more than 20 international conference presentations as invited speakers and technical session chairs. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science.
Sponsored by SGS Life Sciences
SGS Life Sciences is a leading contract service organization providing analytical development, biologics characterization, biosafety and quality control testing. Operating a wholly-owned network of 18 laboratories in 11 countries, SGS delivers complete lifecycle solutions for pharmaceutical, biologics, and medical device manufacturers. Our services include: analytical chemistry, microbiology, stability studies, bioanalysis, extractables/leachables, virology and protein analysis.
SGS is experienced in testing extractables and leachables from primary and secondary packaging for pharmaceuticals, process equipment including single use systems, and components parts from medical devices. SGS designs and performs extractable and leachable studies that will satisfy regulatory authorities such as the FDA and EMA as well as adhere to ASTM, ISPE, PQRI, BPOG, BPSA, and PDA recommendations.