Biowaste Management During Biopharmaceutical Plant Start-Up: From Regulatory Guidance to Verified Inactivation Methods - - BioPharm International

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Biowaste Management During Biopharmaceutical Plant Start-Up: From Regulatory Guidance to Verified Inactivation Methods


BioPharm International


Had pertinent data relating to chemical inactivation of CHO cells been available at the start-up of our facility, it would have been possible to move quickly and directly to an annual verification of the chosen methods. This paper should supply to other groups valuable in-formation that may be used in justifying the selection and use of similar inactivation procedures in their own facilities.

Mary Heenan, senior scientist, Process Development, Development & Technical Services, The Wyeth BioPharma Campus at Grange Castle, Wyeth Medica Ireland, Grange Castle International Business Park, Clondalkin Dublin 22, Ireland, 01.4696814, Fax: 01.4696896,

REFERENCES

1. Fink R, Moran E. Biosafety for large-scale containment level 1 operations using recombinant DNA technology: No emerging hazards. Applied Biosafety. 2005; 10:30-39.

2. Ebling MJ, Miller S. Validation of a batch type biological waste treatment system. Pharmaceutical Engineering. 1991;11:42-48.

3. Carlson CJ. Biowaste Systems. Pharmaceutical Engineering. 2001;21:70-82.

4. Gregoriades N, Luzardo M, Lucquet B, Ryll T. Heat inactivation of mammalian cell cultures for biowaste kill system design. Biotechnol. Prog. 2003;19:14-20.

5. Block SS, ed. Disinfection, Sterilization, and Preservation. 5th ed. Philadelphia: Lippincott, Williams & Wilkins; 2001.


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