Abstract
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.
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- Article
- Abstract
- Background
- Evaluation of Performance Attributes Supporting Maintained Viral Clearance By Chromatography Columns At End of Lifetime
- John Mattila, Regeneron
- Review of Viral Clearance Capacity of Used Chromatography Resins In Biologics Purification Processes
- Glen Bolton, Amgen
- Evaluation of Virus Carryover and Lifetime In Non-platform Process
- Shohei Kobayashi, Chugai Pharmaceutical Co., LTD
- Virus Clearance By Chromatograph: Resin Lifetime and Carryover Studies
- Dayue Chen, Lilly
- Retrospective Evaluation of Cycled Resin In Viral Clearance Studies—a Multiple Company Collaboration
- John Mattila, Regeneron Pharmaceuticals Inc.; Mike Clark, AbbVie Inc.; Justin Weaver and Jeremy Pike, Alexion; Bradford Stanley, Biogen; Deqiang Yu, Bristol-Myers Squibb; Eileen Wilson and Olga Galperina, GlaxoSmithKline plc; Xinfang Li, ImmunoGen Inc. (now of MabPlex); David Roush and Scott Tobler, Merck, Sharp and Dohme, Inc.; Sherrie Curtis, Roche; Andreas Flicker and Johanna Kindermann, Shire plc; Norbert Schuelke, Takeda; Richard Whitcombe, UCB
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