RT Journal Article
SR Electronic
T1 Identification and Root Cause Analysis of the Visible Particles Commonly Encountered in the Biopharmaceutical Industry
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 586
OP 603
DO 10.5731/pdajpst.2023.012894
VO 78
IS 5
A1 Wang, Bo
A1 Zhang, Shanshan
A1 Chen, Mengyi
A1 Lei, Ming
A1 Gao, Tian
A1 Fan, Wei
A1 Huang, Jincui
A1 Cao, Xiaolin
YR 2024
UL http://journal.pda.org/content/78/5/586.abstract
AB Visible particle is an important issue in the biopharmaceutical industry, and it may occur across all the stages in the life cycle of biologics. Upon the occurrence of visible particles, it is often necessary to conduct chemical identification and root cause analysis to safeguard the safety and efficacy of the biotherapeutic products. In this article, we present a number of typical particles and relevant root cause analysis in the categories of extrinsic, intrinsic, and inherent particles that are commonly encountered in the biopharma industry. In particular, the optical images of particles obtained both in situ and after isolation are provided, along with spectral and elemental information. The particle identification was carried out with multiple microscopic and microspectroscopic techniques, including stereo optical microscopy, Fourier-transform infrared microscopy, confocal Raman microscopy, scanning electron microscopy, and energy dispersive X-ray spectroscopy. Both commercial and in-house spectral databases were used for comparison and identification. In addition to particle identification, we placed significant efforts on the root cause analysis of the addressed particles with the intention to provide a relatively whole picture of the particle-related issues and practical references to particle mitigation for our peers in the biopharmaceutical industry.