Addressing Subvisible Silicone Oil Droplets-Industry Challenges, Analytical Strategies, and USP's Rationale...

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Full title: Addressing Subvisible Silicone Oil Droplets-Industry Challenges, Analytical Strategies, and USP's Rationale for a New General Informational Chapter Subvisible silicone oil droplets (SiOPs) originating from siliconized prefilled syringes have become a significant contributor to subvisible particulate matter (SbVP) in biopharmaceutical products. While silicone oil is essential for device functionality, dispersed droplets complicate compendial particle measurements, challenge method specificity, and may interact with therapeutic proteins. This presentation synthesizes insights from a recent Pharmacopeial Forum Stimuli article titled and “Addressing Subvisible Silicone Oil Droplets—Industry Challenges, Analytical Strategies, and USP's Rationale for a New General Informational Chapter”. We will examine the industry context of subvisible silicone oil droplets (SiOPs) across evolving delivery systems, including prefilled syringes and autoinjectors, and various administration routes except intravitreal use. This overview will compare analytical strategies such as light obscuration, flow imaging with morphology filters, orthogonal methods like NMR/ICP-MS and Raman/FTIR, and emerging tools such as holographic microscopy and AI-enabled image analysis, focusing on their limitations, variability, and fit-for-purpose application. Clinical and safety data will be discussed, emphasizing the low intrinsic toxicity of silicone oil and the context-dependent nature of immunogenicity risks. We will also outline development and lifecycle control strategies—covering siliconization processes, container selection, formulation factors, and manufacturing controls—and present a risk-based framework for product-specific specifications and regulatory engagement when SiOPs impact apparent SbVP levels.

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15:00 - 16:00 hs GMT+1

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Marzo / 2026 11 webinars

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Lun 23 de Marzo de 2026

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Overview of modern car compromise techniques and methods of protection

05:00 - 06:00 hs GMT+1

Overview of modern car compromise techniques and methods of protection

Fecha

Jue 26-Mar-2026, 05:00 - 06:00 hs GMT+1

Descripción

Modern cars employ a wide array of communication interfaces. Some, like Bluetooth and Wi-Fi, directly engage users, while others, such as RDS and GPS, provide user-facing services, and still others, like CAN and Ethernet buses, ensure the proper functioning of (...)

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Vie 27 de Marzo de 2026

Shift + ALT + Disrupt: Friday Forward

13:00 - 14:00 hs GMT+1

Shift + ALT + Disrupt: Friday Forward

Fecha

Vie 27-Mar-2026, 13:00 - 14:00 hs GMT+1

Descripción

"Friday Forward" is a 30-minute conversation that takes place every 2 weeks and covers the Public Sector digital transformation topics that are driving conversations in the federal government, state and local governments, public safety, education and health care. Michael Hackmer will (...)

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Sáb 28 de Marzo de 2026

Dom 01 de Marzo de 2026

Lun 02 de Marzo de 2026

Mar 03 de Marzo de 2026

Sophie Drinkwater, Associate Director in Microbiology at AstraZeneca

15:00 - 16:00 hs GMT+1

Sophie Drinkwater, Associate Director in Microbiology at AstraZeneca

Fecha

Mar 3-Mar-2026, 15:00 - 16:00 hs GMT+1

Descripción

This presentation explores the use of solid phase cytometry for in process bioburden, short shelf-life product and water testing. Solid phase cytometry is being looked at as the new frontier for pharmaceutical microbiology especially for cell and gene therapy. The (...)

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Mié 04 de Marzo de 2026

Addressing Subvisible Silicone Oil Droplets-Industry Challenges, Analytical Strategies, and USP's Rationale...

15:00 - 16:00 hs GMT+1

Addressing Subvisible Silicone Oil Droplets-Industry Challenges, Analytical Strategies, and USP's Rationale...

Fecha

Mié 4-Mar-2026, 15:00 - 16:00 hs GMT+1

Descripción

Full title: Addressing Subvisible Silicone Oil Droplets-Industry Challenges, Analytical Strategies, and USP's Rationale for a New General Informational Chapter Subvisible silicone oil droplets (SiOPs) originating from siliconized prefilled syringes have become a significant contributor to subvisible particulate matter (SbVP) in biopharmaceutical (...)

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Jue 05 de Marzo de 2026

Securing Multi-Cloud Environments: Best Practices for Cloud Posture Management

14:00 - 15:00 hs GMT+1

Securing Multi-Cloud Environments: Best Practices for Cloud Posture Management

Fecha

Jue 5-Mar-2026, 14:00 - 15:00 hs GMT+1

Descripción

As organizations embrace multi-cloud strategies, maintaining consistent security and compliance across diverse cloud environments becomes increasingly complex. Misconfigurations, unmanaged assets, and fragmented visibility often open doors to risk. In this webinar, discover how Saner Cloud simplifies Cloud Posture Management by providing (...)

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Vie 06 de Marzo de 2026

Sáb 07 de Marzo de 2026

Dom 08 de Marzo de 2026

Lun 09 de Marzo de 2026

Mar 10 de Marzo de 2026

Mié 11 de Marzo de 2026

Shift + ALT + Disrupt (Episode 5): AI Trends in Public Sector

18:00 - 19:00 hs GMT+1

Shift + ALT + Disrupt (Episode 5): AI Trends in Public Sector

Fecha

Mié 11-Mar-2026, 18:00 - 19:00 hs GMT+1

Descripción

This episode of “Shift + ALT + Disrupt,” we are all about AI - exploring the latest trends in Artificial Intelligence (AI) across different segments of the Public Sector, what challenges agencies and organizations are experiencing, and how can the (...)

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Jue 12 de Marzo de 2026

Considerations for mRNA-LNP Potency Assay Development for Gene Editing Products

14:00 - 15:00 hs GMT+1

Considerations for mRNA-LNP Potency Assay Development for Gene Editing Products

Fecha

Jue 12-Mar-2026, 14:00 - 15:00 hs GMT+1

Descripción

Presented by Benjamin Hall, Associate Director in Analytical Development at Tessera Therapeutics

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Vie 13 de Marzo de 2026

Shift + ALT + Disrupt: Friday Forward

13:00 - 14:00 hs GMT+1

Shift + ALT + Disrupt: Friday Forward

Fecha

Vie 13-Mar-2026, 13:00 - 14:00 hs GMT+1

Descripción

"Friday Forward" is a 30-minute conversation that takes place every 2 weeks and covers the Public Sector digital transformation topics that are driving conversations in the federal government, state and local governments, public safety, education and health care. Michael Hackmer will (...)

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Sáb 14 de Marzo de 2026

Dom 15 de Marzo de 2026

Lun 16 de Marzo de 2026

Developing a Site-Wide Contamination Control Strategy: From Risk Mapping to Implementation

14:00 - 15:00 hs GMT+1

Developing a Site-Wide Contamination Control Strategy: From Risk Mapping to Implementation

Fecha

Lun 16-Mar-2026, 14:00 - 15:00 hs GMT+1

Descripción

Recent revisions to EU GMP Annex 1 have significantly reshaped expectations for contamination control strategy (CCS), requiring manufacturers to adopt a holistic, risk-based approach. This poster presents a real-world case study from a global pharmaceutical company that has implemented a (...)

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Mar 17 de Marzo de 2026

Mié 18 de Marzo de 2026

Jue 19 de Marzo de 2026

What your security stack isn't catching: Identifying hidden threats

05:00 - 06:00 hs GMT+1

What your security stack isn't catching: Identifying hidden threats

Fecha

Jue 19-Mar-2026, 05:00 - 06:00 hs GMT+1

Descripción

The threat landscape is evolving rapidly—and not to your advantage. According to the latest Kaspersky MDR Analyst Report, one in four companies faced advanced persistent threats (APTs) in 2024, with these attacks making up over 43% of all high-severity cybersecurity incidents—a (...)

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Vie 20 de Marzo de 2026

Regulatory Challenges of Recent Low Endotoxin Recovery Regulatory Queries

14:00 - 15:00 hs GMT+1

Regulatory Challenges of Recent Low Endotoxin Recovery Regulatory Queries

Fecha

Vie 20-Mar-2026, 14:00 - 15:00 hs GMT+1

Descripción

Full title: Regulatory Challenges of Recent Low Endotoxin Recovery Regulatory Queries: Pfizer’s Strategy to Evaluate and Implement Global Changes to Meet Evolving Expectations The frequency and scope of inquiries related to Low Endotoxin Recovery (LER) from health authorities for biotherapeutic product (...)

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Sáb 21 de Marzo de 2026

Dom 22 de Marzo de 2026

Lun 23 de Marzo de 2026

Mar 24 de Marzo de 2026

Mié 25 de Marzo de 2026

Jue 26 de Marzo de 2026

Overview of modern car compromise techniques and methods of protection

05:00 - 06:00 hs GMT+1

Overview of modern car compromise techniques and methods of protection

Fecha

Jue 26-Mar-2026, 05:00 - 06:00 hs GMT+1

Descripción

Modern cars employ a wide array of communication interfaces. Some, like Bluetooth and Wi-Fi, directly engage users, while others, such as RDS and GPS, provide user-facing services, and still others, like CAN and Ethernet buses, ensure the proper functioning of (...)

Más detalles »
Cerrar

Vie 27 de Marzo de 2026

Shift + ALT + Disrupt: Friday Forward

13:00 - 14:00 hs GMT+1

Shift + ALT + Disrupt: Friday Forward

Fecha

Vie 27-Mar-2026, 13:00 - 14:00 hs GMT+1

Descripción

"Friday Forward" is a 30-minute conversation that takes place every 2 weeks and covers the Public Sector digital transformation topics that are driving conversations in the federal government, state and local governments, public safety, education and health care. Michael Hackmer will (...)

Más detalles »
Cerrar

Sáb 28 de Marzo de 2026

Dom 29 de Marzo de 2026

Lun 30 de Marzo de 2026

Mar 31 de Marzo de 2026

Mié 01 de Marzo de 2026

Jue 02 de Marzo de 2026

Vie 03 de Marzo de 2026

Sophie Drinkwater, Associate Director in Microbiology at AstraZeneca

15:00 - 16:00 hs GMT+1

Sophie Drinkwater, Associate Director in Microbiology at AstraZeneca

Fecha

Vie 3-Mar-2026, 15:00 - 16:00 hs GMT+1

Descripción

This presentation explores the use of solid phase cytometry for in process bioburden, short shelf-life product and water testing. Solid phase cytometry is being looked at as the new frontier for pharmaceutical microbiology especially for cell and gene therapy. The (...)

Más detalles »
Cerrar

Sáb 04 de Marzo de 2026

Addressing Subvisible Silicone Oil Droplets-Industry Challenges, Analytical Strategies, and USP's Rationale...

15:00 - 16:00 hs GMT+1

Addressing Subvisible Silicone Oil Droplets-Industry Challenges, Analytical Strategies, and USP's Rationale...

Fecha

Sáb 4-Mar-2026, 15:00 - 16:00 hs GMT+1

Descripción

Full title: Addressing Subvisible Silicone Oil Droplets-Industry Challenges, Analytical Strategies, and USP's Rationale for a New General Informational Chapter Subvisible silicone oil droplets (SiOPs) originating from siliconized prefilled syringes have become a significant contributor to subvisible particulate matter (SbVP) in biopharmaceutical (...)

Más detalles »
Cerrar

Dom 05 de Marzo de 2026

Securing Multi-Cloud Environments: Best Practices for Cloud Posture Management

14:00 - 15:00 hs GMT+1

Securing Multi-Cloud Environments: Best Practices for Cloud Posture Management

Fecha

Dom 5-Mar-2026, 14:00 - 15:00 hs GMT+1

Descripción

As organizations embrace multi-cloud strategies, maintaining consistent security and compliance across diverse cloud environments becomes increasingly complex. Misconfigurations, unmanaged assets, and fragmented visibility often open doors to risk. In this webinar, discover how Saner Cloud simplifies Cloud Posture Management by providing (...)

Más detalles »
Cerrar

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Empresa de publicidad exterior Lamar pone en marcha Oracle Fusion Cloud ERP

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Rimini Street dará soporte a todas las versiones de SAP ECC 6.0 y S/4HANA hasta 2040

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Publicado el 6-Jun-2025 • 17.47hs

Addressing Subvisible Silicone Oil Droplets-Industry Challenges, Analytical Strategies, and USP's Rationale... - ERP Spain.com - España y América Latina

Portal sobre Software y productos ERP

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