Advanced in vitro exposure systems.

24. Feb. 2020

In vitro advances in whole aerosol approaches for e-cigarette testing

IIVS Workshop 3, Feb 24-26th 2020

Autor

David Thorne, British American Tobacco

 

Workshop series to identify, discuss and develop recommendations for the optimal generation and use of in vitro data for product regulation.

 

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31. Dec. 2019

High Throughput Air Liquid Interface Exposure Modules: Characterization of Smoke/Aerosol Dosimetry and in vitro Mutagenicity and Cytotoxicity of Two Tobacco Product Types

Robert Leverette1, Brian Keyser1, Michael Hollings2 and Adam Seymour2
1RAI Services Company, Winston−Salem, NC 27101 USA
2Covance Laboratories Ltd., Harrogate, North Yorkshire HG3 1PY, UK

 

• Freshly generated whole smoke / aerosol from three different tobacco product types (3R4F, THP and ENDS) was consistently delivered within the AMES 48 and 6/48 exposure modules.
• Biological endpoints: 3R4F whole smoke induced increased revertant counts (Ames) and cytotoxicity (NRU) in the AMES 48 and 6/48 modules, respectively.
• Revertant counts (Ames) and cytotoxicity (IC50) values were comparable to those from the standard exposure modules when run under similar exposure conditions.
• Overall, the AMES 48 and 6/48 modules are deemed “Fit for Use" for the in vitrO evaluation of different tobacco product types (combustible, THP, ENDS).
 

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30. Nov. 2019

Characterization of Whole Mainstream Smoke/Aerosol Delivery within the Vitrocell® Ames 48 High Throughput Exposure Module Using Different Tobacco Product Types.

1Leverette R, 1Keyser B, 2Seymour A and 2Hollings M
1Scientific & Regulatory Affairs, RAI Services Company, Winston-Salem, NC 27101
2Covance Laboratories Ltd, Otley Road, Harrogate, North Yorkshire HG3 1PY, UK

 

  • Freshly generated whole smoke from the 3R4F reference cigarette (HCI; TPM) and aerosol from either a commercially available THP (HCI; glycerol) or ENDS (CRM81; glycerol) were delivered consistently within the Vitrocell® AMES 48 High Throughput exposure module.
  • Coefficients of variation (CV) for whole smoke/aerosol deposition within each dose (row) were < 20% (3R4F; TPM) and < 15% (THP and ENDS; glycerol).
  • Overall, the data presented demonstrate the consistent delivery of whole smoke/aerosol under controlled conditions and a reproducible in vitro biological response (Ames) with the Vitrocell® AMES 48 High Throughput exposure module. HCI 3R4F whole smoke exposures do require additional range finding experiments for optimization.
  • Ames activity of 3R4F whole smoke, when generated under similar conditions, was comparable when using either the Vitrocell® AMES 48 High Throughput exposure module or the Vitrocell® Standard exposure modules (Figure 6).
  • The Vitrocell® AMES 48 exposure module is a useful tool to increase sample throughput for the in vitro toxicological assessment of freshly generated whole smoke and aerosols from different tobacco product types (combustible, THP and ENDS). The AMES 48 module allows 7 smoke/aerosol doses (with 6 cultures per dose) per exposure versus only 2 (HCI) - 4 (ISO) doses (with 3 cultures per dose) for the standard exposure modules (when using a VC10® smoking machine).

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30. Nov. 2019

Dosimetric Analysis of Aerosol Generated by a Vitrocell® VC10® Smoking Robot – Investigations on Dose Dependency and Consistency of Application


Adam Seymour, Michael Hollings, Joanne Larner and Julie Clements;

Covance Laboratories Ltd, Harrogate, UK


QCMs were used to assess the deposition of cigarette aerosol from a Vitrocell® VC10® in Vitrocell® Ames, 6/4, 12/4 and 24/4 exposure modules. The power to resolve difference between 8 and 1 SLPM is statistically significant in all module types assessed. Uniformity within each module was confirmed (P >0.98) in all module types, at all airflows. Repeatability was assessed and found to be consistent (no significant difference) in all module types at airflows of 10, 8 and 4 SLPM, however, at 1 SLPM a significant difference was noted in 9 out of 12 experiments – likely an artifact of high deposition.
These results show that exposures utilizing the Vitrocell® VC10® and associated modules are robust; but indicate the necessity of dosimetry measures to aid in the quantification of delivered dose.
 

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4. Nov. 2019

Investigation of multiple whole smoke dosimetry techniques using a VITROCELL®VC10® smoke exposure system

https://doi.org/10.1016/j.toxrep.2019.10.011

Brian M. Keysera, Robert Leverettea, Michael Hollingsb, Adam Seymourb, Lesley Reeveb, Wanda Fieldsa
a RAI Services Company, Scientific & Regulatory Affairs, 401 North Main Street, Winston-Salem, NC, 27101, USA1
b Covance Laboratories Ltd., North Yorkshire, UK

 

Highlights
• Investigation of dose-determining methods using the Vitrocell® VC10® system.
• Dose assessment using Quartz Crystal Microbalances (QCM) and aerosol photometers.
• Dose assessment using fluorescence of DMSO-captured smoke constituents.
• QCM, photometer AUC, and DMSO-captured matter were consistent and reproducible

 

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25. Oct. 2019

VITROCELL® High Throughput Exposure Module: Deposition and Cytotoxicity of Smoke/Aerosol from Different Tobacco Product Types

User Group Meeting 2019

1Leverette R, 1Keyser B, 2Seymour A, 2Hollings M and 1Bombick B
1Scientific & Regulatory Affairs, RAI Services Company Winston-Salem, NC 27102
2Covance Laboratories Ltd Otley Road, Harrogate, North Yorkshire HG3 1PY, UK

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25. Oct. 2019

New holder for ENDS products for VITROCELL® Smoking Machines and Robots

User Group Meeting 2019

Bastian Gutmann, Tobias Krebs
VITROCELL Systems GmbH 79183 Waldkirch, Germany

The poster shows the new holder for ENDS products

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10. Mar. 2019

New Products at VITROCELL® User Group Meeting 2019

09 March 2019, Hilton Inner Harbour Hotel, Baltimore, USA

Following the VITROCELL® User Group Meeting 2018 in San Antonio, Texas, USA, international scientists from Europe, Japan, Korea and USA reconvened in March 2019.

The informal event organized into short presentations and posters was followed by open discussions. It was an excellent opportunity to discuss the latest developments of VITROCELL®, to exchange your experience in working with the equipment and to meet other fellow researchers.
The meeting took place prior to the international Society of Toxicology 58th Annual Meeting and ToxExpo, March 10 – 14, 2018, in Baltimore, USA - one of the largest international conferences related to toxicology.

Focus of the event was to share VITROCELL® activities since the last meeting, to exchange latest research results, to give an update on VITROCELL’s participation in major research programs as well as the presentation of new products for 2019.

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18. Dec. 2018

Development of a quantitative method for assessment of dose in in vitro evaluations using a VITROCELL® VC10® smoke exposure system

https://doi.org/10.1016/j.tiv.2018.12.010

Brian M. Keysera, Robert Leverettea, Kathy Fowlera, Wanda Fieldsa, Victoria Hargreavesb, Lesley Reeveb, Betsy Bombicka
a RAI Services Company1, Scientific & Regulatory Affairs, 401 North Main Street, Winston-Salem, NC 27101, USA
b Covance Laboratories Ltd., North Yorkshire, UK

The aims of this study were to investigate dosimetry during whole smoke exposure in the VITROCELL® VC10® smoking robot using QCMs and to determine whether photometers could be used for concurrent assessment of dose during in vitro whole smoke exposures.

 

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28. Oct. 2018

Big tobacco embraces in vitro toxicology

Manufacturers invest in nonanimal tests to evaluate health risks of e-cigarettes and other next-generation tobacco products

c&en, Volume 96, Issue 43

Britt E. Erickson

The complexity of next-generation tobacco products has increased by a number of factors since FDA was given responsibility to regulate tobacco. Testing e-liquids with animals is not practical, economically and not that accurate. The Vitrocell system generates airborne materials from test products, such as smoke from reference cigarettes and vapor from e-cigarettes, in a manner that simulates how a person would puff. This artcile shows, how IIVS scientists use human donor tissues, obtained from organs, to create cell cultures and in vitro test systems.


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