An Industry Proposal for a Cell and Gene Therapy Safety Data Sheet-Reference-Cited by-同舟云学术

An Industry Proposal for a Cell and Gene Therapy Safety Data Sheet

Published:2023-09-01 Issue:3 Volume:28 Page:176-191
ISSN:1535-6760
Container-title:Applied Biosafety
language:en
Short-container-title:Applied Biosafety

Author:

Wu Qirong¹,Elkind Shana²,Preston Francine³,Wachala Michael⁴,Dunn Erin⁵,White Sarah K.⁶,Windhorst Dirk⁷,DiGiandomenico Kimberly⁸,McGuire Colin⁹,Brok Herbert¹⁰,Hodges Rachel¹¹

Affiliation:

1. Janssen, Spring House, Pennsylvania, USA.

2. Rocket Pharmaceuticals, Inc., Cranbury, New Jersey, USA.

3. Johnson & Johnson Services, Inc., Spring House, Pennsylvania, USA.

4. 2seventy bio, Cambridge, Massachusetts, USA.

5. Fujifilm Diosynth Biotechnologies, College Station, Texas, USA.

6. Thermo Fisher Scientific, Waltham, Massachusetts, USA.

7. Sanofi Aventis Deutschland GmbH, Frankfurt, Germany.

8. AstraZeneca, Gaithersburg, Maryland, USA.

9. Formally of Thermo Fisher Scientific, Waltham, Massachusetts, USA.

10. Lonza, Geleen, The Netherlands.

11. BioPhorum Operations Group Ltd., London, United Kingdom.

Publisher

Mary Ann Liebert Inc

Subject

Health, Toxicology and Mutagenesis,Management, Monitoring, Policy and Law,Public Health, Environmental and Occupational Health,Biotechnology

Link

https://www.liebertpub.com/doi/pdf/10.1089/apb.2023.0009

Reference5 articles.

1. Immunotoxicology of Biological Response Modifiers

2. Viral Vector Systems for Gene Therapy: A Comprehensive Literature Review of Progress and Biosafety Challenges

3. Occupational Exposure Risks When Working with Protein Therapeutics and the Development of a Biologics Banding System

4. Considerations for setting occupational exposure limits for novel pharmaceutical modalities

5. Risks Associated With Lentiviral Vector Exposures and Prevention Strategies