Rory Budihandojo
Rory Budihandojo
Rory Budihandojo
Director, Quality Systems Audit
Boehringer Ingelheim Shanghai Pharmaceuticals
Rory Budihandojo is the director of quality systems audit at Boehringer Ingelheim Shanghai Pharmaceuticals. He has more than 20 years of worldwide pharmaceutical experience (including Pfizer, GSK, Schering Plough) with responsibilities in R&D, manufacturing (API and finished dosage), QA, IT, pharmaceutical technology, and quality audit. He performed method, process, facility, utility, equipment, and computer validation, as well as GMP auditing of contract manufacturers, suppliers, and internal audits. He has validated chromatography, LIMS, PLC, SCADA, DCS, DMS, BAS, ERP, SAP, change-control systems, and more.
He was a member of PhRMA and PDA CSV Committee, and a founding member of GAMP Americas, and now serves as the vice-chairman and as a global GAMP Council member. He has published several articles in computer validation and was the lead author of PDA Technical Report No. 31. He serves on the editorial board of Pharmaceutical Technology, BioPharm International, Pharma Magazine, Pharm Tech Europe, and Pharmaceutical Engineering. He has a diploma in electronics, and degrees in chemistry and mathematics.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
