Jianfeng Hong - uventia

Jianfeng Hong

Jianfeng Hong

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.

4th Annual Extractables & Leachables
March 7, 2024
What is next in testing and analyzing for extractables and leachables in biopharmaceutical development and release? Recording of 2 days event sessions [18 video sessions].

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.

3rd Annual Extractables & Leachables
March 9, 2023
Learn innovative techniques for analyzing and testing for extractables and leachables in biopharmaceutical development. Recording of 2 days event sessions [20 video sessions].

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.

Speaker Details
Speaker Details