RT Journal Article
SR Electronic
T1 Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 488
OP 497
DO 10.5731/pdajpst.2018.009134
VO 72
IS 5
A1 Johannes Blümel
A1 Junfen Ma
YR 2018
UL http://journal.pda.org/content/72/5/488.abstract
AB In many downstream processes, chromatographic purification steps contribute significantly to the overall virus reduction capacity. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q5A(R1) outlines that “Over time and after repeated use, the ability of chromatography columns and other devices used in the purification scheme to clear virus may vary. Some estimate of the stability of the viral clearance after several uses may provide support for repeated use of such columns.” Virus reduction studies with used resin normally require a high amount of in-process material and time. The experience with used resin has been accumulated continuously, stimulating the discussion on whether it would be necessary to investigate virus reduction on used resins for each product. In this session, additional experience from studies with used resins was provided.LAY ABSTRACT: In many downstream processes, chromatographic purification steps contribute significantly to the overall virus reduction capacity. An estimate of the stability of the viral clearance after several uses may provide support for repeated use of such columns. Virus reduction studies with used resin normally require a high amount of in-process material and time. The experience with used resin has been accumulated continuously, stimulating the discussion on whether it would be necessary to investigate virus reduction on used resins for each product. In this session, additional experience from studies with used resins was provided.