Process Development and Spiking Studies for Virus Filtration of r-hFSH - This study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of cont

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Process Development and Spiking Studies for Virus Filtration of r-hFSH
This study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.


BioPharm International
pp. 24-30

SUMMARY

Virus filtration in downstream purification of recombinant proteins may potentially represent a high-cost unit operation step, often due to the high cost of the virus filters as well as the low filter flow or throughput obtainable with these filters. It would, therefore, pay to devote sufficient time to develop and optimize the process to minimize the filtration area requirements for the process step. The current study, with recombinant human follicle stimulating hormone, demonstrates the development techniques employed to optimize the implementation of a virus filtration step in the downstream purification process.

Mahesh Gavasane is senior manager, Ansari Usman Ali is an executive, Anita Samagod is general manager, John Kaundinya is president, Gautam Daftary is managing director, all at R&D Group, Bharat Serums & Vaccines, Maharashtra. Thomas Preuss is study director, Horst Ruppach is global manager, viral clearance, both at Charles River Biopharmaceutical Services GmbH, Cologne, Germany. Nikhil Shaligram is process development scientist, Bala Raghunath is WW director, Subhasis Banerjee*, is manager, India and Singapore,
, all at Biomanufacturing Sciences Network Group, Merck Millipore, Millipore India.

*To whom all correspondance should be addressed.

REFERENCES

1. ICH, Q5a Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (Geneva, 1999).

2. D.R. Asher et al., Bioproces. Intl. 9 (3), 26-37 (2011).

3. W. Kools, Bioprocessing J. 11 (2), 42-47 (2012).

4. B. Raghunath and J. Royce, Bioprocess. Intl. 4 (7), 56-57 (2006)

5. Note for guidance on virus validation studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses (CPMP/BWP/268/95, February 1996).

6. Note on guidance on quality of biotechnological products: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin (CPMP/ICH/295/95, October 1997).


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