Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

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Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

1. Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

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Community Leadership

Kayla Woodlief

Posted 11-11-2024 10:39

Reminder that our monthly Stability Community meeting is this Thursday, Nov 14 at 12 PM PT / 3PM ET

Agenda

Topic	Subtopic	Lead	Meeting Notes (check box indicates action is required)
Introductions	First time attendees/ new members	Community
Introductions	2025 Leadership Team	Community	Chair: Kayla Woodlief, Vir Bio Vice-Chair: Sherilyn Campie, Coherus Past Chair: Vinaya Kapoor, Arcus Biosciences Secretary: Dan Willingmyre, Vir Bio Member Engagement Manager: Stephanie Ferrari Learning Opportunities Manager: Kim HuynhBa, Pharmalytik
2025 Objectives	N/A	Kayla	Webinars Drive Member engagement by hosting webinar/virtual discussion once per quarter Community Collaborations Continue cross-collaborations with other AAPS communities Stats: Quarterly collaborations Reg CMC: Potential collaboration in 1Q25 on AI Sterile Products Community Knowledge Sharing Time allocated at each monthly meeting to discuss topic of interest, community page/e-mail questions, etc. Publications At least 2 publications annually
Community Updates	Publications	Community	Book Specification of Drug Substance and Products (Kim, Chris, Lori, Laura Pack) Papers
	Regulatory Guidelines	Community	ICH Guidance Updates (Lori) Others USP Chapter on Biologics Stability (Stephanie/Camilla)
	Conferences	Kim / Lori	PharmSci 360 Update Upcoming Conferences CMC Strategy/WCBP (Jan'25) KENX Laboratory University (May'25)
	Webinars	Community	Prof. Schöneich from University of Kansas; Photostability of Therapeutic Protein Modalities: Products, Mechanisms, and Mitigation Timing: 19Nov – 12:30 -2 PM ET ; part 2 in 1Q25
Knowledge Sharing	Shipping – Survey responses and reflections	Camilla / Nanda
Knowledge Sharing	Topics for Future Meetings

------------------------------
Kayla Woodlief B.S.
Director
Vir Biotechnology
Cary NC
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

2. RE: Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

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Community Leadership

Kayla Woodlief

Posted 11-15-2024 16:36

Thank you everyone that attended this month's Stability Community meeting. Great discussion and minutes are posted below. Please note the 2 webinars next week that may be of interest to the community

Topic	Subtopic	Lead	Meeting Notes (check box indicates action is required)
Introductions	First time attendees/ new members	Community	Welcome Jennifer Miller, Pfizer (St. Louis)
Introductions	2025 Leadership Team	Community	Special thanks to Vinaya for the excellent leadership in 2024 as chair! Chair: Kayla Woodlief, Vir Bio Vice-Chair: Sherilyn Campie, Coherus Past Chair: Vinaya Kapoor, Arcus Biosciences Secretary: Dan Willingmyre, Vir Bio Member Engagement Manager: Stephanie Ferrari Learning Opportunities Manager: Kim HuynhBa, Pharmalytik
2025 Objectives	N/A	Kayla	Webinars Drive Member engagement by hosting webinar/virtual discussion once per quarter Community Collaborations Continue cross-collaborations with other AAPS communities Stats: Quarterly collaborations Reg CMC: Potential collaboration in 1Q25 on AI Sterile Products Community Knowledge Sharing Time allocated at each monthly meeting to discuss topic of interest, community page/e-mail questions, etc. Publications At least 2 publications annually
Community Updates	Publications	Community	Book Specification of Drug Substance and Products (Kim, Chris, Lori, Laura Pack) https://www.amazon.com/Specification-Drug-Substances-Products-Development/dp/0443134669/ref=sr_1_1?crid=1FHUJS4XCGW53&dib=eyJ2IjoiMSJ9.Sq4siPeb3D3tFrt0FWV9vXgYnTjNSBPZEhN0Wq8l2Y3GjHj071QN20LucGBJIEps.3obSPW7bPurreb4Y1q1Bs-JH8Yax8zVqaw087EaNBMk&dib_tag=se&keywords=specifications+for+drug+products+Riley&qid=1731615036&sprefix=specifications+for+drug+products+riley%2Caps%2C105&sr=8-1 Papers Stability Lifecycle: An Application of ICH Q12 to Manage the Pharmaceutical Stability Program https://www.americanpharmaceuticalreview.com/Featured-Articles/613529-Stability-Lifecycle-An-Application-of-ICH-Q12-to-Manage-the-Pharmaceutical-Stability-Program/ Stability modeling methodologies to enable earlier patient access https://jpharmsci.org/action/showPdf?pii=S0022-3549%2824%2900425-8
	Regulatory Guidelines	Community	ICH Guidance Updates (Lori) Q1: Public draft most likely available in Feb Others USP Chapter on Biologics Stability (Stephanie/Camilla) Addendum to 1049.1. Second round on gaining agreement & approvals through USP. Next year: commenting
	Conferences	Kim / Lori	PharmSci 360 Update Potential discussion topics for the team: physical chemistry, Product Investigations & Stability, Organization of Stability within companies Upcoming Conferences CMC Strategy/WCBP (Jan'25) KENX Laboratory University (May'25) Data & Clouds – webinar IABS Conference update
	Webinars / Community Collaborations	Community	Photostability Prof. Schöneich from University of Kansas; Photostability of Therapeutic Protein Modalities: Products, Mechanisms, and Mitigation Timing: 19Nov – 12:30 -2 PM ET ; part 2 in 1Q25 Registration link: https://learning.aaps.org/topclass/topclass.do?expand-OfferingDetails-Offeringid=316159 Data in the Cloud Webinar Presentation from AWS representatives on their experience with European regulations, which will be held on November 21^st at 12:30 PM ET. The link to register is here: NOV 21 - Data Security and European Regulations with Cloud Service Providers Stats/Stability Joint Meeting Agenda for 21Nov24 meeting Recap of 2024 activities & topics for 2025 Discussion on interesting topics from IABS Conference Potential Future Topics 1Q25: Reference Standards (Stephanie/Helen) Comparability for Stability Use of stability & stats on specification setting Accelerated stability studies to support biosimilar
Knowledge Sharing	Shipping – Survey responses and reflections	Camilla / Nanda	18 total responses received. Survey attached Paper published from IQ working group on Industry Perspectives on Temperature Cycling Studies to meet regulatory requirements
Knowledge Sharing	Topics for Future Meetings		Physical Stability Product Investigations & Stability Stability testing & acceptance criteria for Reference standards

------------------------------
Kayla Woodlief B.S.
Director
Vir Biotechnology
Cary NC
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Original Message

Original Message:
Sent: 11-11-2024 10:39
From: Kayla Woodlief
Subject: Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

Reminder that our monthly Stability Community meeting is this Thursday, Nov 14 at 12 PM PT / 3PM ET

Agenda

Topic	Subtopic	Lead	Meeting Notes (check box indicates action is required)
Introductions	First time attendees/ new members	Community
Introductions	2025 Leadership Team	Community	Chair: Kayla Woodlief, Vir Bio Vice-Chair: Sherilyn Campie, Coherus Past Chair: Vinaya Kapoor, Arcus Biosciences Secretary: Dan Willingmyre, Vir Bio Member Engagement Manager: Stephanie Ferrari Learning Opportunities Manager: Kim HuynhBa, Pharmalytik
2025 Objectives	N/A	Kayla	Webinars Drive Member engagement by hosting webinar/virtual discussion once per quarter Community Collaborations Continue cross-collaborations with other AAPS communities Stats: Quarterly collaborations Reg CMC: Potential collaboration in 1Q25 on AI Sterile Products Community Knowledge Sharing Time allocated at each monthly meeting to discuss topic of interest, community page/e-mail questions, etc. Publications At least 2 publications annually
Community Updates	Publications	Community	Book Specification of Drug Substance and Products (Kim, Chris, Lori, Laura Pack) Papers
	Regulatory Guidelines	Community	ICH Guidance Updates (Lori) Others USP Chapter on Biologics Stability (Stephanie/Camilla)
	Conferences	Kim / Lori	PharmSci 360 Update Upcoming Conferences CMC Strategy/WCBP (Jan'25) KENX Laboratory University (May'25)
	Webinars	Community	Prof. Schöneich from University of Kansas; Photostability of Therapeutic Protein Modalities: Products, Mechanisms, and Mitigation Timing: 19Nov – 12:30 -2 PM ET ; part 2 in 1Q25
Knowledge Sharing	Shipping – Survey responses and reflections	Camilla / Nanda
Knowledge Sharing	Topics for Future Meetings

------------------------------
Kayla Woodlief B.S.
Director
Vir Biotechnology
Cary NC
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

3. RE: Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

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Community Leadership

Kayla Woodlief

Posted 11-15-2024 16:40

| view attached (3)

Papers and presentations from our November meeting. Thanks Lori, Nanda, and Camilla for your great talks!

------------------------------
Kayla Woodlief B.S.
Director
Vir Biotechnology
Cary NC
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Attachment(s)

JPharmSci112(2023)2981-2990.pdf 1.04 MB 1 version

PS360 Oct2024 Recap (003).pdf 2.63 MB 1 version

AAPS Stability and Shipping Survey Results.pdf 1.06 MB 1 version

Original Message

Original Message:
Sent: 11-15-2024 16:35
From: Kayla Woodlief
Subject: Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

Thank you everyone that attended this month's Stability Community meeting. Great discussion and minutes are posted below. Please note the 2 webinars next week that may be of interest to the community

Topic	Subtopic	Lead	Meeting Notes (check box indicates action is required)
Introductions	First time attendees/ new members	Community	Welcome Jennifer Miller, Pfizer (St. Louis)
Introductions	2025 Leadership Team	Community	Special thanks to Vinaya for the excellent leadership in 2024 as chair! Chair: Kayla Woodlief, Vir Bio Vice-Chair: Sherilyn Campie, Coherus Past Chair: Vinaya Kapoor, Arcus Biosciences Secretary: Dan Willingmyre, Vir Bio Member Engagement Manager: Stephanie Ferrari Learning Opportunities Manager: Kim HuynhBa, Pharmalytik
2025 Objectives	N/A	Kayla	Webinars Drive Member engagement by hosting webinar/virtual discussion once per quarter Community Collaborations Continue cross-collaborations with other AAPS communities Stats: Quarterly collaborations Reg CMC: Potential collaboration in 1Q25 on AI Sterile Products Community Knowledge Sharing Time allocated at each monthly meeting to discuss topic of interest, community page/e-mail questions, etc. Publications At least 2 publications annually
Community Updates	Publications	Community	Book Specification of Drug Substance and Products (Kim, Chris, Lori, Laura Pack) https://www.amazon.com/Specification-Drug-Substances-Products-Development/dp/0443134669/ref=sr_1_1?crid=1FHUJS4XCGW53&dib=eyJ2IjoiMSJ9.Sq4siPeb3D3tFrt0FWV9vXgYnTjNSBPZEhN0Wq8l2Y3GjHj071QN20LucGBJIEps.3obSPW7bPurreb4Y1q1Bs-JH8Yax8zVqaw087EaNBMk&dib_tag=se&keywords=specifications+for+drug+products+Riley&qid=1731615036&sprefix=specifications+for+drug+products+riley%2Caps%2C105&sr=8-1 Papers Stability Lifecycle: An Application of ICH Q12 to Manage the Pharmaceutical Stability Program https://www.americanpharmaceuticalreview.com/Featured-Articles/613529-Stability-Lifecycle-An-Application-of-ICH-Q12-to-Manage-the-Pharmaceutical-Stability-Program/ Stability modeling methodologies to enable earlier patient access https://jpharmsci.org/action/showPdf?pii=S0022-3549%2824%2900425-8
	Regulatory Guidelines	Community	ICH Guidance Updates (Lori) Q1: Public draft most likely available in Feb Others USP Chapter on Biologics Stability (Stephanie/Camilla) Addendum to 1049.1. Second round on gaining agreement & approvals through USP. Next year: commenting
	Conferences	Kim / Lori	PharmSci 360 Update Potential discussion topics for the team: physical chemistry, Product Investigations & Stability, Organization of Stability within companies Upcoming Conferences CMC Strategy/WCBP (Jan'25) KENX Laboratory University (May'25) Data & Clouds – webinar IABS Conference update
	Webinars / Community Collaborations	Community	Photostability Prof. Schöneich from University of Kansas; Photostability of Therapeutic Protein Modalities: Products, Mechanisms, and Mitigation Timing: 19Nov – 12:30 -2 PM ET ; part 2 in 1Q25 Registration link: https://learning.aaps.org/topclass/topclass.do?expand-OfferingDetails-Offeringid=316159 Data in the Cloud Webinar Presentation from AWS representatives on their experience with European regulations, which will be held on November 21^st at 12:30 PM ET. The link to register is here: NOV 21 - Data Security and European Regulations with Cloud Service Providers Stats/Stability Joint Meeting Agenda for 21Nov24 meeting Recap of 2024 activities & topics for 2025 Discussion on interesting topics from IABS Conference Potential Future Topics 1Q25: Reference Standards (Stephanie/Helen) Comparability for Stability Use of stability & stats on specification setting Accelerated stability studies to support biosimilar
Knowledge Sharing	Shipping – Survey responses and reflections	Camilla / Nanda	18 total responses received. Survey attached Paper published from IQ working group on Industry Perspectives on Temperature Cycling Studies to meet regulatory requirements
Knowledge Sharing	Topics for Future Meetings		Physical Stability Product Investigations & Stability Stability testing & acceptance criteria for Reference standards

------------------------------
Kayla Woodlief B.S.
Director
Vir Biotechnology
Cary NC
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 11-11-2024 10:39
From: Kayla Woodlief
Subject: Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

Reminder that our monthly Stability Community meeting is this Thursday, Nov 14 at 12 PM PT / 3PM ET

Agenda

Topic	Subtopic	Lead	Meeting Notes (check box indicates action is required)
Introductions	First time attendees/ new members	Community
Introductions	2025 Leadership Team	Community	Chair: Kayla Woodlief, Vir Bio Vice-Chair: Sherilyn Campie, Coherus Past Chair: Vinaya Kapoor, Arcus Biosciences Secretary: Dan Willingmyre, Vir Bio Member Engagement Manager: Stephanie Ferrari Learning Opportunities Manager: Kim HuynhBa, Pharmalytik
2025 Objectives	N/A	Kayla	Webinars Drive Member engagement by hosting webinar/virtual discussion once per quarter Community Collaborations Continue cross-collaborations with other AAPS communities Stats: Quarterly collaborations Reg CMC: Potential collaboration in 1Q25 on AI Sterile Products Community Knowledge Sharing Time allocated at each monthly meeting to discuss topic of interest, community page/e-mail questions, etc. Publications At least 2 publications annually
Community Updates	Publications	Community	Book Specification of Drug Substance and Products (Kim, Chris, Lori, Laura Pack) Papers
	Regulatory Guidelines	Community	ICH Guidance Updates (Lori) Others USP Chapter on Biologics Stability (Stephanie/Camilla)
	Conferences	Kim / Lori	PharmSci 360 Update Upcoming Conferences CMC Strategy/WCBP (Jan'25) KENX Laboratory University (May'25)
	Webinars	Community	Prof. Schöneich from University of Kansas; Photostability of Therapeutic Protein Modalities: Products, Mechanisms, and Mitigation Timing: 19Nov – 12:30 -2 PM ET ; part 2 in 1Q25
Knowledge Sharing	Shipping – Survey responses and reflections	Camilla / Nanda
Knowledge Sharing	Topics for Future Meetings

------------------------------
Kayla Woodlief B.S.
Director
Vir Biotechnology
Cary NC
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

4. RE: Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

Like

Community Leadership

Vaneeta Grover

Posted 01-09-2025 15:14

Hello,

I am trying to find call in information for the meeting, could someone please share?

Thanks,

Vaneeta

Original Message

Original Message:
Sent: 11/11/2024 10:39:00 AM
From: Kayla Woodlief
Subject: Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

Reminder that our monthly Stability Community meeting is this Thursday, Nov 14 at 12 PM PT / 3PM ET

Agenda

Topic	Subtopic	Lead	Meeting Notes (check box indicates action is required)
Introductions	First time attendees/ new members	Community
Introductions	2025 Leadership Team	Community	Chair: Kayla Woodlief, Vir Bio Vice-Chair: Sherilyn Campie, Coherus Past Chair: Vinaya Kapoor, Arcus Biosciences Secretary: Dan Willingmyre, Vir Bio Member Engagement Manager: Stephanie Ferrari Learning Opportunities Manager: Kim HuynhBa, Pharmalytik
2025 Objectives	N/A	Kayla	Webinars Drive Member engagement by hosting webinar/virtual discussion once per quarter Community Collaborations Continue cross-collaborations with other AAPS communities Stats: Quarterly collaborations Reg CMC: Potential collaboration in 1Q25 on AI Sterile Products Community Knowledge Sharing Time allocated at each monthly meeting to discuss topic of interest, community page/e-mail questions, etc. Publications At least 2 publications annually
Community Updates	Publications	Community	Book Specification of Drug Substance and Products (Kim, Chris, Lori, Laura Pack) Papers
	Regulatory Guidelines	Community	ICH Guidance Updates (Lori) Others USP Chapter on Biologics Stability (Stephanie/Camilla)
	Conferences	Kim / Lori	PharmSci 360 Update Upcoming Conferences CMC Strategy/WCBP (Jan'25) KENX Laboratory University (May'25)
	Webinars	Community	Prof. Schöneich from University of Kansas; Photostability of Therapeutic Protein Modalities: Products, Mechanisms, and Mitigation Timing: 19Nov – 12:30 -2 PM ET ; part 2 in 1Q25
Knowledge Sharing	Shipping – Survey responses and reflections	Camilla / Nanda
Knowledge Sharing	Topics for Future Meetings

------------------------------
Kayla Woodlief B.S.
Director
Vir Biotechnology
Cary NC
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

5. RE: Stability Community Monthly Meeting - Thursday, Nov 14 12PM PT / 3PM ET

Like

Community Ambassador

Kanyaphat (Wow) Bunchongprasert

Posted 01-09-2025 15:17

Hi,

Me too. Tried the Teams Link in Oct, but couldn't get in either.

Best,

Wow

------------------------------
Kanyaphat (Wow) Bunchongprasert
CMC Manager, Analytical & Stability
Upstream Bio
West Orange NJ
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Original Message

Stability Community