Jianfeng Hong
Sr. Research Scientist
Jianfeng Hong received his Master degree of Analytical Chemistry from University of Louisville, USA and Bachelor and Master degrees of Chemistry from Sun Yat-sen University of P.R. China.
From 1995-2007, he worked for several pharmaceutical companies and a research organization include PPD, Pfizer and Baxter as an analytical chemist performing analyses of pharmaceuticals and impurities /degradants in drug formulations and in biological fluids using HPLC, UPLC/UV/MS and GC/MS analytical techniques.
Since 2008, he worked for Fenwal (a Baxter spin off company and now a part of Fresenius Kabi) to establish the extractable / leachable chemistry testing lab for medical device and parenteral pharmaceutical contact closure system. The test lab is equipped with advanced analytical instrument such as UPLC/MS, GC/MS and ICP/MS with modern high resolution mass spectrometers.
He has been leading the analytical chemists of the laboratory to perform extractable / leachable analyses to support parenteral pharmaceutical and medical device product development and product life cycle management. The E/L tests include parenteral pharmaceutical containers (pre-filled syringes, vials etc.) and medical device material (sheeting, port tube, filter, label, diaphragms etc.) for blood and cellular component separation/collection for infusion therapies.
He is a recognized expert in the space for chemical characterizations for medical device material and pharmaceutical contact closure system. He is a frequent invited speaker for national and international extractable/leachable and biocompatibility conferences and workshops.
DAY 2: MARCH 8th, 2024
SESSION: Leachable study of a parenteral vial products with complex and challenging formulations
◆ Extractable study results.
◆ Leachable simulation study.
◆ Target Leahcable test method validations.
◆ Leachable Test Results (6 months and 24 months).
◆ Summary and Conclusions.
DAY 1: MARCH 9th, 2023
SESSION: UPLC/MS and GC/MS method development and validations of extractable and leachable compounds of a parenteral product
This presentation describes the design of method development and validation of several representative extractable/leachable compounds in a parenteral product using GC/MS, head space GC/MS and UPLC/MS techniques.
The rationale of the selections of the compounds and the analytical method performance requirements are presented.
The validated method parameters and validation results are presented: (1) Limit of Quantitation, (2) Accuracy/recovery, (3) Linearity and (4) Standard/sample stability. The validated analytical methods are also successfully used for leachable testing of the parenteral products that have been stored under ICH conditions.
