Extractable Study Design and Data Evaluation of Polymeric Product Contact Materials
05th June 2018 | 10 AM EST | Dr. Ping Wang, Principal Scientist, Janssen R&D and Dr Nixdorf, SGS Group |WATCH FOR FREE
Concerns over the safety and drug product qualities due to extractables and leachables (E&L) from polymeric Product Contact Materials (PCM), especially single use systems, in the manufacturing, packaging and delivery of biologics have increased in recent years. Based on surveys and author’s experience, almost all major regulatory agencies require the E&L risk assessment of PCM for new biologics license applications (BLA). To ensure the E&L data are suitable for the assessment of intended application of the PCM, the health authorities are paying close attention to the study design, analytical assays employed, and how the extractable data being used to conduct a safety risk assessment of the materials. The key to the success is to ensure the study design and data interpretation is product and process specific. The lack of relevant E&L data from suppliers presents end-users a great challenge. Strategies of developing relevant extractable data and applying that in the toxicological evaluation will be discussed.
Presented by Dr. Ping Wang, Principal Scientist, Janssen R&D
Dr. Ping Wang is a Principal Scientist with Janssen R&D. He has been leading Janssen’s effort in the evaluation, selection and risk assessment related to polymeric materials used in the manufacturing, packaging and delivery of biologics, small molecules and transdermal drug products for the past ten years. His main interests and expertise are risk based material evaluation, E&L strategies and methodologies, single use systems, biocompatibility, biologics drug development, analytical technologies, regulatory implications and toxicological assessment of impurities. He is a board member of Extractables and Leachables Safety Information Exchange (ELSIE) Consortium. As an active member of Biophorum Operations Group (BPOG), he was a key contributor to the BPOG’s standardized extractable protocol, and the best practice guide for leachable risk assessment. He earned a PhD in pharmacy, received a Regulatory Affairs Certificate (RAC), and an MBA degree.
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 20 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.
Presented by Dr Andreas Nixdorf, SGS Group
Dr. Nixdorf has been with the SGS Group in Germany since 2007, and is currently senior project manager in the Life Sciences division, with a primary focus in Extractable and Leachable projects. Dr. Nixdorf has a strong background in quality control testing of finished drug products and analytical method development and validation, residue analysis of different biological and polymer materials; and has been dealing with analytical challenges and questions for over 20 years. With a PhD in organic chemistry, majoring in mass spectrometry, Dr. Nixdorf worked for various contract laboratories and was head of a laboratory for about 8 years.