Inactivation of enveloped and non-enveloped viruses in the process of chemical treatment and gamma irradiation of bovine-derived grafting materials

Kwang Il Lee, Jung Soo Lee, Hong Hee Jung, Hwa Yong Lee, seonghwan moon, Kyoung Tak Kang, Young Bock Shim, Ju Woong Jang

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Xenografts, unlike other grafting products, cannot be commercialized unless they conform to stringent safety regulations. Particularly with bovine-derived materials, it is essential to remove viruses and inactivate infectious factors because of the possibility that raw materials are imbrued with infectious viruses. The removal of the characteristics of infectious viruses from the bovine bone grafting materials need to be proved and inactivation process should satisfy the management provision of the Food and Drug Administration (FDA). To date, while most virus inactivation studies were performed in human allograft tissues, there have been almost no studies on bovine bone. Methods: To evaluate the efficacy of virus inactivation after treatment of bovine bone with 70% ethanol, 4% sodium hydroxide, and gamma irradiation, we selected a variety of experimental model viruses that are known to be associated with bone pathogenesis, including bovine parvovirus (BPV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), and bovine parainfluenza-3 virus (BPIV-3). The cumulative virus log clearance factor or cumulative virus log reduction factor for the manufacturing process was obtained by calculating the sum of the individual virus log clearance factors or log reduction factors determined for individual process steps with different physicochemical methods. Results: The cumulative log clearance factors achieved by three different virus inactivation processes were as follows: BPV ≤17.73, BHV ≤20.53, BVDV ≤19.00, and BPIV-3 ≤16.27. On the other hand, the cumulative log reduction factors achieved were as follows: BPV ≤16.95, BHV ≤20.22, BVDV ≤19.27, and BPIV-3 ≤15.58. Conclusions: Treatment with 70% ethanol, 4% sodium hydroxide, or gamma irradiation was found to be very effective in virus inactivation, since all viruses were at undetectable levels during each process. We have no doubt that application of this established process to bovine bone graft manufacture will be effective and essential.

Original languageEnglish
Pages (from-to)365-369
Number of pages5
JournalXenotransplantation
Volume19
Issue number6
DOIs
Publication statusPublished - 2012 Nov 1

Fingerprint

Chemical Phenomena
Viruses
Virus Inactivation
Bocavirus
Bovine Viral Diarrhea Viruses
Therapeutics
Bone and Bones
Sodium Hydroxide
Bovine parainfluenza virus 3
Ethanol
Bone Transplantation
United States Food and Drug Administration
Heterografts
Allografts

All Science Journal Classification (ASJC) codes

  • Immunology
  • Transplantation

Cite this

Lee, Kwang Il ; Lee, Jung Soo ; Jung, Hong Hee ; Lee, Hwa Yong ; moon, seonghwan ; Kang, Kyoung Tak ; Shim, Young Bock ; Jang, Ju Woong. / Inactivation of enveloped and non-enveloped viruses in the process of chemical treatment and gamma irradiation of bovine-derived grafting materials. In: Xenotransplantation. 2012 ; Vol. 19, No. 6. pp. 365-369.
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abstract = "Background: Xenografts, unlike other grafting products, cannot be commercialized unless they conform to stringent safety regulations. Particularly with bovine-derived materials, it is essential to remove viruses and inactivate infectious factors because of the possibility that raw materials are imbrued with infectious viruses. The removal of the characteristics of infectious viruses from the bovine bone grafting materials need to be proved and inactivation process should satisfy the management provision of the Food and Drug Administration (FDA). To date, while most virus inactivation studies were performed in human allograft tissues, there have been almost no studies on bovine bone. Methods: To evaluate the efficacy of virus inactivation after treatment of bovine bone with 70{\%} ethanol, 4{\%} sodium hydroxide, and gamma irradiation, we selected a variety of experimental model viruses that are known to be associated with bone pathogenesis, including bovine parvovirus (BPV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), and bovine parainfluenza-3 virus (BPIV-3). The cumulative virus log clearance factor or cumulative virus log reduction factor for the manufacturing process was obtained by calculating the sum of the individual virus log clearance factors or log reduction factors determined for individual process steps with different physicochemical methods. Results: The cumulative log clearance factors achieved by three different virus inactivation processes were as follows: BPV ≤17.73, BHV ≤20.53, BVDV ≤19.00, and BPIV-3 ≤16.27. On the other hand, the cumulative log reduction factors achieved were as follows: BPV ≤16.95, BHV ≤20.22, BVDV ≤19.27, and BPIV-3 ≤15.58. Conclusions: Treatment with 70{\%} ethanol, 4{\%} sodium hydroxide, or gamma irradiation was found to be very effective in virus inactivation, since all viruses were at undetectable levels during each process. We have no doubt that application of this established process to bovine bone graft manufacture will be effective and essential.",
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Inactivation of enveloped and non-enveloped viruses in the process of chemical treatment and gamma irradiation of bovine-derived grafting materials. / Lee, Kwang Il; Lee, Jung Soo; Jung, Hong Hee; Lee, Hwa Yong; moon, seonghwan; Kang, Kyoung Tak; Shim, Young Bock; Jang, Ju Woong.

In: Xenotransplantation, Vol. 19, No. 6, 01.11.2012, p. 365-369.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Inactivation of enveloped and non-enveloped viruses in the process of chemical treatment and gamma irradiation of bovine-derived grafting materials

AU - Lee, Kwang Il

AU - Lee, Jung Soo

AU - Jung, Hong Hee

AU - Lee, Hwa Yong

AU - moon, seonghwan

AU - Kang, Kyoung Tak

AU - Shim, Young Bock

AU - Jang, Ju Woong

PY - 2012/11/1

Y1 - 2012/11/1

N2 - Background: Xenografts, unlike other grafting products, cannot be commercialized unless they conform to stringent safety regulations. Particularly with bovine-derived materials, it is essential to remove viruses and inactivate infectious factors because of the possibility that raw materials are imbrued with infectious viruses. The removal of the characteristics of infectious viruses from the bovine bone grafting materials need to be proved and inactivation process should satisfy the management provision of the Food and Drug Administration (FDA). To date, while most virus inactivation studies were performed in human allograft tissues, there have been almost no studies on bovine bone. Methods: To evaluate the efficacy of virus inactivation after treatment of bovine bone with 70% ethanol, 4% sodium hydroxide, and gamma irradiation, we selected a variety of experimental model viruses that are known to be associated with bone pathogenesis, including bovine parvovirus (BPV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), and bovine parainfluenza-3 virus (BPIV-3). The cumulative virus log clearance factor or cumulative virus log reduction factor for the manufacturing process was obtained by calculating the sum of the individual virus log clearance factors or log reduction factors determined for individual process steps with different physicochemical methods. Results: The cumulative log clearance factors achieved by three different virus inactivation processes were as follows: BPV ≤17.73, BHV ≤20.53, BVDV ≤19.00, and BPIV-3 ≤16.27. On the other hand, the cumulative log reduction factors achieved were as follows: BPV ≤16.95, BHV ≤20.22, BVDV ≤19.27, and BPIV-3 ≤15.58. Conclusions: Treatment with 70% ethanol, 4% sodium hydroxide, or gamma irradiation was found to be very effective in virus inactivation, since all viruses were at undetectable levels during each process. We have no doubt that application of this established process to bovine bone graft manufacture will be effective and essential.

AB - Background: Xenografts, unlike other grafting products, cannot be commercialized unless they conform to stringent safety regulations. Particularly with bovine-derived materials, it is essential to remove viruses and inactivate infectious factors because of the possibility that raw materials are imbrued with infectious viruses. The removal of the characteristics of infectious viruses from the bovine bone grafting materials need to be proved and inactivation process should satisfy the management provision of the Food and Drug Administration (FDA). To date, while most virus inactivation studies were performed in human allograft tissues, there have been almost no studies on bovine bone. Methods: To evaluate the efficacy of virus inactivation after treatment of bovine bone with 70% ethanol, 4% sodium hydroxide, and gamma irradiation, we selected a variety of experimental model viruses that are known to be associated with bone pathogenesis, including bovine parvovirus (BPV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), and bovine parainfluenza-3 virus (BPIV-3). The cumulative virus log clearance factor or cumulative virus log reduction factor for the manufacturing process was obtained by calculating the sum of the individual virus log clearance factors or log reduction factors determined for individual process steps with different physicochemical methods. Results: The cumulative log clearance factors achieved by three different virus inactivation processes were as follows: BPV ≤17.73, BHV ≤20.53, BVDV ≤19.00, and BPIV-3 ≤16.27. On the other hand, the cumulative log reduction factors achieved were as follows: BPV ≤16.95, BHV ≤20.22, BVDV ≤19.27, and BPIV-3 ≤15.58. Conclusions: Treatment with 70% ethanol, 4% sodium hydroxide, or gamma irradiation was found to be very effective in virus inactivation, since all viruses were at undetectable levels during each process. We have no doubt that application of this established process to bovine bone graft manufacture will be effective and essential.

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