Upcoming Events

Global Health Community Monthly Meeting - 11th October 2024

Hello AAPS-GHC members Please join our monthly Global Health Community meeting on 11th October at 12.15pm (EST). We will discuss: 2025 Community Mission & Goals, Plans for the upcoming AAPS360 conference, Volunteer opportunities for you to take an active role in this great Community Meeting link: https://meet.goto.com/471580205 Kieran Crowley Vice-Chair

OCT 16 - An Alternative to USP Residual Ethylene Oxide Testing Using SIFT-MS

Residual ethylene oxide (EtO) is a toxic and carcinogenic impurity in multiple commonly used pharmaceutical excipients such as polysorbate, polyethylene glycol (PEG), and polyethylene oxide (PEO). Limits on the presence of EtO in pharmaceutical products are in place, and it is routinely measured using USP chapter <228>, Ethylene Oxide and Dioxane. Real-time mass spectrometry provides an attractive option for rapid testing of consumer and pharmaceutical products for these and similar volatile organic compounds (VOCs). An alternative method for quantitation of residual EtO is in development using SIFT-MS which provides real-time results. This eChalk Talk discusses an alternative method in development for the quantitation of residual EtO using SIFT-MS which provides real-time results. This method takes a typically two-day protocol for sample preparation and analysis and provides the same quantitative result in under two hours, including blanks and system suitability solutions. It uses a small fraction of the amount traditionally required and reduces or eliminates concerns about chromatographic resolution and sensitivity associated with proposed revisions to USP Chapter <621>, Chromatography. Experiments are ongoing to validate this procedure as an alternative method for USP <228> and related PEG, PEO, and polysorbate monographs. Speaker Information K. Chad Bastian, Ph.D. Chad Bastian is a Principal Scientist at Alcami Corp., a pharmaceutical contract development and manufacturing organization headquartered in North Carolina. He has over 20 years of experience using liquid and gas chromatography coupled with mass spectrometry to support pre-clinical development of small molecules and biologicals, including characterization, impurity identification, release and stability studies, and extractable and leachable testing. Prior to working in industry, Chad worked as a post-doctoral researcher with the Water Resources Division of the USGS (Lawrence, Kansas) after obtaining his Ph.D. in civil/environmental engineering at Purdue University (West Lafayette, Indiana).

OCT 16 - An Alternative to USP Residual Ethylene Oxide Testing Using SIFT-MS

Residual ethylene oxide (EtO) is a toxic and carcinogenic impurity in multiple commonly used pharmaceutical excipients such as polysorbate, polyethylene glycol (PEG), and polyethylene oxide (PEO). Limits on the presence of EtO in pharmaceutical products are in place, and it is routinely measured using USP chapter <228>, Ethylene Oxide and Dioxane. Real-time mass spectrometry provides an attractive option for rapid testing of consumer and pharmaceutical products for these and similar volatile organic compounds (VOCs). An alternative method for quantitation of residual EtO is in development using SIFT-MS which provides real-time results. This eChalk Talk discusses an alternative method in development for the quantitation of residual EtO using SIFT-MS which provides real-time results. This method takes a typically two-day protocol for sample preparation and analysis and provides the same quantitative result in under two hours, including blanks and system suitability solutions. It uses a small fraction of the amount traditionally required and reduces or eliminates concerns about chromatographic resolution and sensitivity associated with proposed revisions to USP Chapter <621>, Chromatography. Experiments are ongoing to validate this procedure as an alternative method for USP <228> and related PEG, PEO, and polysorbate monographs. Speaker Information K. Chad Bastian, Ph.D. Chad Bastian is a Principal Scientist at Alcami Corp., a pharmaceutical contract development and manufacturing organization headquartered in North Carolina. He has over 20 years of experience using liquid and gas chromatography coupled with mass spectrometry to support pre-clinical development of small molecules and biologicals, including characterization, impurity identification, release and stability studies, and extractable and leachable testing. Prior to working in industry, Chad worked as a post-doctoral researcher with the Water Resources Division of the USGS (Lawrence, Kansas) after obtaining his Ph.D. in civil/environmental engineering at Purdue University (West Lafayette, Indiana).

OCT 16 - An Alternative to USP Residual Ethylene Oxide Testing Using SIFT-MS

Residual ethylene oxide (EtO) is a toxic and carcinogenic impurity in multiple commonly used pharmaceutical excipients such as polysorbate, polyethylene glycol (PEG), and polyethylene oxide (PEO). Limits on the presence of EtO in pharmaceutical products are in place, and it is routinely measured using USP chapter <228>, Ethylene Oxide and Dioxane. Real-time mass spectrometry provides an attractive option for rapid testing of consumer and pharmaceutical products for these and similar volatile organic compounds (VOCs). An alternative method for quantitation of residual EtO is in development using SIFT-MS which provides real-time results. This eChalk Talk discusses an alternative method in development for the quantitation of residual EtO using SIFT-MS which provides real-time results. This method takes a typically two-day protocol for sample preparation and analysis and provides the same quantitative result in under two hours, including blanks and system suitability solutions. It uses a small fraction of the amount traditionally required and reduces or eliminates concerns about chromatographic resolution and sensitivity associated with proposed revisions to USP Chapter <621>, Chromatography. Experiments are ongoing to validate this procedure as an alternative method for USP <228> and related PEG, PEO, and polysorbate monographs. Speaker Information K. Chad Bastian, Ph.D. Chad Bastian is a Principal Scientist at Alcami Corp., a pharmaceutical contract development and manufacturing organization headquartered in North Carolina. He has over 20 years of experience using liquid and gas chromatography coupled with mass spectrometry to support pre-clinical development of small molecules and biologicals, including characterization, impurity identification, release and stability studies, and extractable and leachable testing. Prior to working in industry, Chad worked as a post-doctoral researcher with the Water Resources Division of the USGS (Lawrence, Kansas) after obtaining his Ph.D. in civil/environmental engineering at Purdue University (West Lafayette, Indiana).

AAPS' 2024 PharmSci 360

October 20-23, 2024 Salt Palace Convention Center Salt Lake City, UT From discovery to delivery, PharmSci 360 covers everything in pharmaceutical sciences, with a focus on: Discovery and Basic Research. Preclinical and Translational Sciences. Bioanalytics. Manufacturing and Analytical Characterization.

MSE Open Meeting at PharmSci 360

Join us at PharmSci360 for an open MSE Community Meeting. No need to be members, come and meet scientists in Manufacturing Science and Engineering.

2024 AAPS Topical and Transdermal Community Membership Meeting during PharmSci 360

🚨Join us at the 2024 AAPS Topical and Transdermal Community Membership Meeting during PharmSci 360! 🚨 🗓 Date: Tuesday, October 22, 2024 ⏰ Time: 4:00 PM - 5:00 PM 📍 Room: Spotlight Stage A, Exhibit Halls 1 and A-E 🏢 Venue: Salt Palace Convention Center, Salt Lake City, UT Don't miss this opportunity to connect, collaborate, and discuss the latest advancements in topical and transdermal drug delivery with industry experts and peers. Let's drive innovation and scientific knowledge forward together! 💡 # AAPS # PharmSci360 # Topical # Transdermal # PharmaceuticalScience # Networking # Innovation # Collaboration

In person community meeting

Join us for an in-person community meeting where we will discuss 2024 activities and 2025 goals.

Open Scientific Discussion: Preclinical Immunogenicity Support and S6 Guidance Interpretation

Please join for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM), Therapeutic Protein Immunogenicity (TPI) and Bioanalytical (BA) Communities on October 30 th , 12 – 1 pm EST on the following topic: Preclinical Immunogenicity Support and S6 Guidance Interpretation Immunogenicity Assessment in Preclinical Species to Support IND? How critical is the ADA data to support global submissions? Should an Immunogenicity assay be ready to support? Can such assay be qualified rather than validated? Can toxicology study reports be submitted without ADA data if the findings can be interpreted with changes in PK/PD? What is the practice among different sponsors? Some scenarios may include no ADA performed and rely on impact on PK/PD changes or planned but trigger-based to explain safety findings vs generate all ADA data? Decision tree to define when and under what circumstances ADA assays are developed and validated. Risk mitigation strategies that have been used by some sponsors Moderator: · Vibha Jawa Panelists: · Ellen-Marie Koehler-Stec [email protected] · Lauren Stevenson [email protected] · David G Waters [email protected] · Laurent Malherbe [email protected] · Luo, Lina [email protected] · Starcevic Manning, Marta [email protected] ) · Michael Partridge [email protected] · Gerry Kolaitis [email protected] · Jacob Lesniak [email protected] · Jeannine Bussiere [email protected] · Tong-yuan Yang [email protected] Organized by : Vibha Jawa (BMS), Karen Quadrini (Prothena Biosciences), Carmen Fernández-Metzler (PharmaCadence) We start at 12:00 EST sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts. (Please remain on mute unless asking questions) When : Wednesday, Oct. 30, 2024 12pm – 1pm EST Where : Please join from your computer, tablet or smartphone. https://global.gotomeeting.com/join/305789893 You can also dial in using your phone. United States: +1 (872) 240-3412 Access Code: 305-789-893 Join from a video-conferencing room or system. Dial in or type: 67.217.95.2 or inroomlink.goto.com Meeting ID: 305 789 893 Or dial directly: [email protected] or 67.217.95.2##305789893 New to GoToMeeting? Get the app now and be ready when your first meeting starts: https://global.gotomeeting.com/install/305789893 Please feel free to share with colleagues who may be interested in this topic. Thanks, On Behalf of The AAPS BPM, TPI and BA Community Leadership Teams @Carmen Fernandez-Metzler , @Vibha Jawa #webinar

OSD on Preclinical Immunogenicity Support and S6 Guidance Interpretation

Please join for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM), Therapeutic Protein Immunogenicity (TPI) and Bioanalytical (BA) Communities on October 30 th , 12 – 1 pm EST on the following topic: Preclinical Immunogenicity Support and S6 Guidance Interpretation Immunogenicity Assessment in Preclinical Species to Support IND? How critical is the ADA data to support global submissions? Should an Immunogenicity assay be ready to support? Can such assay be qualified rather than validated? Can toxicology study reports be submitted without ADA data if the findings can be interpreted with changes in PK/PD? What is the practice among different sponsors? Some scenarios may include no ADA performed and rely on impact on PK/PD changes or planned but trigger-based to explain safety findings vs generate all ADA data? Decision tree to define when and under what circumstances ADA assays are developed and validated. Risk mitigation strategies that have been used by some sponsors Moderator: · Vibha Jawa Panelists: · Ellen-Marie Koehler-Stec [email protected] · Lauren Stevenson [email protected] · David G Waters [email protected] · Laurent Malherbe [email protected] · Luo, Lina [email protected] · Starcevic Manning, Marta [email protected] ) · Michael Partridge [email protected] · Gerry Kolaitis [email protected] · Jacob Lesniak [email protected] · Jeannine Bussiere [email protected] · Tong-yuan Yang [email protected] Organized by : Vibha Jawa (BMS), Karen Quadrini (Prothena Biosciences), Carmen Fernández-Metzler (PharmaCadence) We start at 12:00 EST sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts. (Please remain on mute unless asking questions) When : Wednesday, Oct. 30, 2024 12pm – 1pm EST Where : Please join from your computer, tablet or smartphone. https://global.gotomeeting.com/join/305789893 You can also dial in using your phone. United States: +1 (872) 240-3412 Access Code: 305-789-893 Join from a video-conferencing room or system. Dial in or type: 67.217.95.2 or inroomlink.goto.com Meeting ID: 305 789 893 Or dial directly: [email protected] or 67.217.95.2##305789893 New to GoToMeeting? Get the app now and be ready when your first meeting starts: https://global.gotomeeting.com/install/305789893 Please feel free to share with colleagues who may be interested in this topic. Thanks, On Behalf of The AAPS BPM, TPI and BA Community Leadershi

Photostability of Therapeutic Protein Modalities: Products, Mechanisms, and Mitigation

Join us for the part 1 of an insightful two-parts webinar series organized by Sterile Products Community and Stability Community of AAPS on the topic of ' Photostability of Therapeutic Protein Modalities: Products, Mechanisms, and Mitigation '. Learning objectives : Mechanisms of initiation of photo-degradation in pharmaceutical formulations Identification of products characteristic for specific photo-degradation mechanisms Identity of reactive intermediates responsible for photo-degradation in pharmaceutical formulations Mitigation Strategies Time : Tuesday, November 19, 2024, 12:30 PM EST Registration link : https://learning.aaps.org/topclass/topclass.do?expand-OfferingDetails-Offeringid=316159 Speaker : Dr. Christian Schöneich, University of Kansas About Dr. Schöneich : Dr. Schöneich is the Takeru Higuchi Distinguished Professor for Bioanalytical Chemistry and Chair of the Department of Pharmaceutical Chemistry at the University of Kansas. Between 1987 and 1991 he worked in the Department of Radiation Chemistry at the Hahn-Meitner Institute in Berlin, Germany, and he received his Ph.D. in Chemistry in 1990 from the Technical University Berlin, Germany. He joined the Department of Pharmaceutical Chemistry at the University of Kansas as a post-doctoral fellow in 1991, and as a faculty member in 1992; in 2004, he was a Visiting Professor at the ETH Zürich, Switzerland. His research focuses on oxidation reactions of peptides and proteins in vivo and in vitro, and their potential consequences for the development of stable protein pharmaceuticals, biological aging and age-related pathologies. He has published >290 papers in the field of redox reactions.