Following up on the OSD with Linda Narhi, a summary of the presented information and discussion is attached. Feedback and questions are welcome.
Original Message:
Sent: 02-13-2024 14:22
From: Mayank Patel
Subject: Open Scientific Discussion: Issues and Challenges for Particle Characterization in Biotherapeutics
Thank you, Linda, for a deeply insightful discussion on visible and subvisible particle detection and control.
The slides presented by Linda are attached to this message. A lot of interesting topics and points came up during the OSD today (13 Feb 2024). Community leadership will summarize these points and identify opportunities for more such discussions in the near future. Please feel free to respond in this thread with your thoughts.
BPABC Community Leadership
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Mayank Patel Ph.D.
Director
AstraZeneca
Gaithersburg MD
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 02-11-2024 11:26
From: Linda Narhi
Subject: Open Scientific Discussion: Issues and Challenges for Particle Characterization in Biotherapeutics
Looking forward to a robust discussion! Hope everyone brings their questions, comments, opinions, etc. Let's see if we can figure out a path forward for some of these topics!
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Linda Narhi Ph.D., FAAPS
Consultant
Camarillo CA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 02-07-2024 13:18
From: Mayank Patel
Subject: Open Scientific Discussion: Issues and Challenges for Particle Characterization in Biotherapeutics
Please join this Open Scientific Discussion (OSD) hosted by the AAPS Biopharmaceutical Product Attributes and Biological Consequences (BPABC) Community on Tuesday, 13 February 2024, 12 PM – 1 PM US EST on:
Issues and Challenges for Particle Characterization in Biotherapeutics
Speaker / Discussion Leader: Linda Narhi, Ph.D. (BioPhia Consulting and Adjunct Professor, UCSB)
Brief Description: Particles remain one of the primary causes of recalls for parenteral drugs. Like all CQAs they should be minimized and controlled. What does this mean for particles, how do we address their potential impact on safety and efficacy, and how do we move to treating particles as any other CQA? Linda will present a brief survey of current pharmacopoeia requirements, and then lead a discussion on some of the current issues and concerns around particles, and future directions. Discussion areas will include:
· Visible versus subvisible particles and the grey zone
· Standardizing visual inspection
· When/should we move to imaging based analysis for both SbVP and VP?
· Particles in Opthalmics
· Topics from participants
We look forward to your participation in a lively discussion on this topic!
When: 13 February 2024, 12 PM – 1 PM US EST
Where: Please join Teams meeting using link provided below from your computer, tablet or smartphone.
https://teams.microsoft.com/l/meetup-join/19%3ameeting_ZjUyZGU1NmItOTM5OC00NTM4LWFhMWQtYjliMzg2OWRjODM4%40thread.v2/0?context=%7b%22Tid%22%3a%22d7811cde-ecef-496c-8f91-a1786241b99c%22%2c%22Oid%22%3a%22da6f9c8c-317b-4a76-90c1-87ab430ab9a3%22%7d
Please feel free to share meeting information with your colleagues who may be interested in this discussion.
Thank you,
BPABC Leadership Team
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Mayank Patel, Ph.D.
Director
AstraZeneca
Gaithersburg MD
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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