Welcome
The purpose of this organization is to foster intercommunication between health, safety, environmental and laboratory professionals within the Pacific Northwest’s biotechnology and biomedical community. The organization accomplishes its purpose by providing a forum for its members. This forum promotes sharing of information, group problem solving, networking and interaction, discussion of common regulatory issues, and education. Our safety issues are both as challenging and rewarding as the rigorous R&D efforts of the organizations we represent.
Post Meeting:
Thanks to all who attended the 2/10/21 meeting.
Further information on the membership in BPOG BioPhorum can be found here: https://www.biophorum.com/membership/
Large Scale Cell and Gene Therapy (CGT) Manufacturing Risk Assessment
In the growing industry of cell and gene therapies there is no standardization across facilities for assessing the unique risks faced by the manufacture of these therapies as medicine. In the paper by Kimberly DiGiandomenico et al Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing published in Applied Biosafety: Journal of ABSA International (2020) the team aims to identify best practices to improve risk controls for occupational health and safety risks associated with facilities and distribution sites in clinical and commercial supply chain of CGTs. Kim will be presenting on BioPhorum organizational goals to standardize risk assessments in CGTs that lead to the development of this paper including current industry risk assessment methodologies and the resulting recommendations for standardized risk assessment for these facilities.
Kimberly DiGiandomenico serves as the Biological Safety Officer and Senior Manager of Biological,
Laboratory, and Radiation Safety at AstraZeneca in Gaithersburg, MD. Kim spent time as a researcher at
the University of Virginia before moving into the safety field while working at Vanderbilt University. She
has been in the safety profession for 15+ years in academic, government and biopharma industries and
is also a Registered Biosafety Professional. She holds a master’s degree in Environmental Science and
Management and has a bachelor’s in biology.
Highlights of her safety career include publication in the peer reviewed journal Applied Biosafety:
Emerging Fields Of Drug Therapies And Their Commercial Scale Production Challenges, 2014 recipient of
the National Poster Award at the American Biological Safety Association Biosafety Conference; Safety,
Health & Environment: SHE Across AstraZeneca 2016 Global Excellence Award; and the recipient of
internal MedImmune awards for supporting various pre-clinical programs.
Thanks to all who attended the 2/10/21 meeting.
Further information on the membership in BPOG BioPhorum can be found here: https://www.biophorum.com/membership/
Large Scale Cell and Gene Therapy (CGT) Manufacturing Risk Assessment
In the growing industry of cell and gene therapies there is no standardization across facilities for assessing the unique risks faced by the manufacture of these therapies as medicine. In the paper by Kimberly DiGiandomenico et al Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing published in Applied Biosafety: Journal of ABSA International (2020) the team aims to identify best practices to improve risk controls for occupational health and safety risks associated with facilities and distribution sites in clinical and commercial supply chain of CGTs. Kim will be presenting on BioPhorum organizational goals to standardize risk assessments in CGTs that lead to the development of this paper including current industry risk assessment methodologies and the resulting recommendations for standardized risk assessment for these facilities.
Kimberly DiGiandomenico serves as the Biological Safety Officer and Senior Manager of Biological,
Laboratory, and Radiation Safety at AstraZeneca in Gaithersburg, MD. Kim spent time as a researcher at
the University of Virginia before moving into the safety field while working at Vanderbilt University. She
has been in the safety profession for 15+ years in academic, government and biopharma industries and
is also a Registered Biosafety Professional. She holds a master’s degree in Environmental Science and
Management and has a bachelor’s in biology.
Highlights of her safety career include publication in the peer reviewed journal Applied Biosafety:
Emerging Fields Of Drug Therapies And Their Commercial Scale Production Challenges, 2014 recipient of
the National Poster Award at the American Biological Safety Association Biosafety Conference; Safety,
Health & Environment: SHE Across AstraZeneca 2016 Global Excellence Award; and the recipient of
internal MedImmune awards for supporting various pre-clinical programs.
Have an idea or suggestion or want to get updates via email?
Want to get reminders of future meetings and other useful information via email? Have some good ideas for future meetings? Submit through this website! Go to our Contact Us page!
Want to get reminders of future meetings and other useful information via email? Have some good ideas for future meetings? Submit through this website! Go to our Contact Us page!
Upcoming General Meetings
2021 Dates:
May 12
August 11
November 10
May 12
August 11
November 10
Upcoming Steering Committee Meetings
2021 Dates: All are at 0900am, unless otherwise noted
April 14
July 14
October 13
Please email us if you have questions or want to participate in planning!
April 14
July 14
October 13
Please email us if you have questions or want to participate in planning!
