Webinar Details
Title: Flow Imaging Microscopy: When Subvisible Particle Counts Aren’t Enough
Date: Tuesday, July 28th
Time: 10:00AM & 4PM EDT

This expert-led panel will explore the benefits of Flow Imaging Microscopy (FIM) across injectable modalities such as high-concentration protein biologics, peptides, long-chain molecules, ADCs/conjugates, and products involving fill-finish or container-closure interactions.

What You’ll Learn:

Recognize common investigation triggers where subvisible particles count alone can delay decisions.

Apply a practical decision framework for image-based evaluation, and when to escalate to chemical and elemental identification when identity and attribution are required.

Identify best-fit product modalities and risk scenarios where FIM typically adds the most value, including high-concentration proteins, peptides, long-chain molecules, ADCs/conjugates, and fill–finish/container-closure interaction risks.

Interpret core FIM deliverables and outline a feasibility-first plan to assess method suitability for challenging matrices and define the next best testing steps.

Join an insightful presentation on issues that can arise at critical stages of the product lifecycle.

Register Here:

Session 1: https://www.pmi-live.com/events/flow-imaging-microscopy-when-subvisible-particle-counts-arent-enough/?utm_source=SP_APT79&utm_medium=SP&utm_content=HTML&utm_campaign=SP_APT79

Session 2: https://www.pmi-live.com/events/flow-imaging-microscopy-when-subvisible-particle-counts-arent-enough-2/?utm_source=SP_APT80&utm_medium=SP&utm_content=HTML&utm_campaign=SP_APT80

Register today and take a proactive step toward safer, more compliant CGT practices. For more information, contact Gateway Analytical at (724) 443-1900 or in**@***************al.com.

The post *Last Call* Register for our Educational Webinar on Flow Imaging Microscopy (FIM) Tomorrow, July 28th! appeared first on Gateway Analytical - Analysis Solutions.

We’ll outline a practical decision framework for when compendial counting methods are sufficient, when FIM adds value, and when confirmatory chemical or elemental techniques (FTIR, Raman, SEM-EDS) are needed to identify the source.

Key Learning Objectives:
Recognize common investigation triggers where subvisible particle counts alone delay decisions.

Apply a practical decision framework to determine when to rely on compendial counting, add FIM, or escalate to chemical/elemental identification.

Identify best-fit modalities and risk scenarios, including high-concentration proteins, peptides, ADCs, and fill-finish/container-closure interactions (silicone oil, glass, elastomer, metal).

Interpret core FIM deliverables and outline a feasibility-first plan to assess method suitability for challenging matrices.

Attendees will discover how we leverage in-house tools and technologies, through practical investigation playbooks, as well as how to interpret FIM outputs, including images, size distributions, count trends, and morphology groupings to refine hypotheses, prioritize follow-up testing, and scale confirmatory work appropriately for faster root-cause direction.

Register Here:

Session 1: https://www.pmi-live.com/events/flow-imaging-microscopy-when-subvisible-particle-counts-arent-enough/?utm_source=SP_APT79&utm_medium=SP&utm_content=HTML&utm_campaign=SP_APT79

Session 2: https://www.pmi-live.com/events/flow-imaging-microscopy-when-subvisible-particle-counts-arent-enough-2/?utm_source=SP_APT80&utm_medium=SP&utm_content=HTML&utm_campaign=SP_APT80

Register today and take a proactive step toward safer, more compliant CGT practices. For more information, contact Gateway Analytical at (724) 443-1900 or in**@***************al.com.

The post Registration Still Open! Join Gateway Analytical on July 28th: Official Flow Imaging Microscopy (FIM) Webinar! appeared first on Gateway Analytical - Analysis Solutions.

We’ll map out an investigation decision tree and a feasibility-first approach so you can quickly evaluate if Flow Imaging Microscopy (FIM) fits your project constraints, saving you time and ensuring compliance on your journey to market..

Register Here:

Session 1: https://www.pmi-live.com/events/flow-imaging-microscopy-when-subvisible-particle-counts-arent-enough/?utm_source=SP_APT79&utm_medium=SP&utm_content=HTML&utm_campaign=SP_APT79

Session 2: https://www.pmi-live.com/events/flow-imaging-microscopy-when-subvisible-particle-counts-arent-enough-2/?utm_source=SP_APT80&utm_medium=SP&utm_content=HTML&utm_campaign=SP_APT80

This expert-led panel will explore the benefits of Flow Imaging Microscopy (FIM) across injectable modalities such as high-concentration protein biologics, peptides, long-chain molecules, ADCs/conjugates, and products involving fill-finish or container-closure interactions.

What You’ll Learn:

Recognize common investigation triggers where subvisible particles count alone can delay decisions.

Apply a practical decision framework for image-based evaluation, and when to escalate to chemical and elemental identification when identity and attribution are required.

Identify best-fit product modalities and risk scenarios where FIM typically adds the most value, including high-concentration proteins, peptides, long-chain molecules, ADCs/conjugates, and fill–finish/container-closure interaction risks.

Interpret core FIM deliverables and outline a feasibility-first plan to assess method suitability for challenging matrices and define the next best testing steps.

Join an insightful presentation on issues that can arise at critical stages of the product lifecycle.

Register today and take a proactive step toward safer, more compliant CGT practices. For more information, contact Gateway Analytical at (724) 443-1900 or in**@***************al.com.

The post *WEBINAR ALERT* Join Gateway Analytical on July 28th: Register for our upcoming Flow Imaging Microscopy Webinar! appeared first on Gateway Analytical - Analysis Solutions.

Right now, we are surrounded by 20,000 global industry leaders, researchers, and innovators. Our industry is fundamentally driven by purpose. Standing here with our peers, it’s clear that what unites us isn’t the pursuit of status or stability, but the unwavering conviction to solve the impossible, push technical boundaries, and achieve positive outcomes for patients.

This shared purpose is what sustains the biopharma community. Being here is our opportunity to connect as a global network, recharge that collective commitment, and ensure the analytical strategies backing your innovations are robust enough to withstand deep-dive regulatory scrutiny and protect critical path timelines.

Ensure your analytical strategy matches the scale of your innovation.

We’re on-site meeting with biopharma teams today to discuss how to ensure quality and patient safety leveraging proactive solutions designed to solve problems before you face a BLA review or an imminent Pre-Approval Inspection (PAI). 

Don’t let an analytical gap stall your critical path timeline while you’re here.

Let’s connect here in San Diego this week @ Booth 5956 to discuss how we can secure your future drug product development timelines. Drop by to meet the team or schedule a dedicated technical consultation with us today:

• Call us directly: (724) 443-1900
• Email our team: in**@***************al.com
• Explore our capabilities: gatewayanalytical.com

The post LIVE in San Diego for the BIO International Convention! appeared first on Gateway Analytical - Analysis Solutions.

BIO International 2026 brings together 20,000 global industry leaders, researchers, and innovators. In a sector where breakthroughs are constantly redefining what is possible, this event serves as a critical junction for the strategic partnerships and technical collaborations that drive high-potential therapies toward commercial reality.

Our industry is fundamentally driven by purpose. This is the force that unites us, not the pursuit of status or stability, but the unwavering conviction to solve the impossible, to push technical boundaries, and to achieve positive outcomes for patients.

This shared purpose is what sustains the biopharma community. It is the collective commitment to ensure that advanced science translates into tangible, life-changing human impact.

BIO International 2026 is our opportunity to reconnect as a global community, to recharge our commitment, and to ensure that the analytical strategies backing our industry’s innovations are robust enough to withstand deep-dive regulatory scrutiny and protect critical path timelines.

Ensure your analytical strategy matches the scale of your innovation. Let’s connect in San Diego to discuss how we can secure your filing timelines and protect your data’s integrity. Schedule a dedicated technical consultation with the Gateway Analytical team today:

Call us: (724) 443-1900

Email us: in**@***************al.com

Explore our capabilities: gatewayanalytical.com

The post BIO International 2026 – SAN DIEGO, CA – 06/22 appeared first on Gateway Analytical - Analysis Solutions.

Gateway Analytical provides a Non-Standard Formulation Control Strategy Review to move programs from passive compliance to proactive governance. We specialize in the intersection of drug formulation and primary container, particularly where standard methods are inadequate. Our strategic review focuses on:

Physical Property Accounting: Defining how turbidity, high concentration, or complex delivery systems impact particulate detection.

Method Defensibility: Selecting and justifying the analytical path (e.g., Method 1 vs. Method 2) before it becomes a deviation.

Lifecycle Risk Reduction: Building a control plan that accounts for the interaction between formulation and primary container.

When standard methods aren’t scientifically defensible, a custom control strategy is the only path to filing robustness.

Curious about next steps? Interested to learn more about our process and toolkit at Gateway Analytical? Schedule your call, or use our Interactive Sample Submission Form here: https://gatewayanalytical.com/contact-us/

Gateway Analytical — Scientific Clarity for Complex Problems.

The post Beyond the Template: Particulate Control Strategies for Non-Standard Modalities appeared first on Gateway Analytical - Analysis Solutions.

Gateway Analytical provides specialized Method Verification Consults to help teams navigate the requirements of USP <787>, <788>, and <789>. We focus on the “Lifecycle Sweet Spot” where products are regulatorily exposed, ensuring your data stands up to FDA, EMA, or Health Canada review.

Our consult focuses on:

Modality-Specific Verification: Tailoring methods for high-risk and non-standard modalities where standard light obscuration may be inadequate.

Analytical Rigor: Establishing verified methods for compendial release and stability that exceed generalist CRO capabilities.

Filing Robustness: Creating technical documentation that provides regulatory confidence during BLA/NDA submissions.

When standard methods aren’t scientifically defensible, we provide the specialized testing required to protect your regulatory timeline.

Curious about next steps? Interested to learn more about our process and toolkit at Gateway Analytical? Schedule your call, or use our Interactive Sample Submission Form here: https://gatewayanalytical.com/contact-us/

Gateway Analytical — Scientific Clarity for Complex Problems.

The post Book Your USP <787>, <788>, or <789> Method Verification Consultation Today! appeared first on Gateway Analytical - Analysis Solutions.

BIO International 2026 – SAN DIEGO, CA – 06/22-06/25 – Gateway Analytical is excited to be attending the BIO International Convention this year in San Diego! 

BIO International 2026 brings together 20,000 global industry leaders, researchers, and innovators. In a sector where breakthroughs are constantly redefining what is possible, this event serves as a critical junction for the strategic partnerships and technical collaborations that drive high-potential therapies toward commercial reality.

Our industry is fundamentally driven by purpose. This is the force that unites us, not the pursuit of status or stability, but the unwavering conviction to solve the impossible, to push technical boundaries, and to achieve positive outcomes for patients.

BIO International 2026 is our opportunity to reconnect as a global community, to recharge our commitment, and to ensure that the analytical strategies backing our industry’s innovations are robust enough to withstand deep-dive regulatory scrutiny and protect critical path timelines.

Ensure your analytical strategy matches the scale of your innovation. Let’s connect in San Diego to discuss how we can secure your filing timelines and protect your data’s integrity. Schedule a dedicated technical consultation with the Gateway Analytical team today:

Call us: (724) 443-1900

Email us: in**@***************al.com

Explore our capabilities: gatewayanalytical.com

The post BIO International 2026 – San Diego, CA appeared first on Gateway Analytical - Analysis Solutions.

When Method 1 and Method 2 suitability is assumed rather than explicitly verified, subvisible particle data becomes vulnerable during audits, filings, and post-approval changes.

Proteinaceous drugs, suspensions, and advanced therapies frequently challenge standard subvisible particle methods. Formulation interference, aggregation behavior, and optical limitations can compromise data quality if method suitability is not demonstrated for the specific product matrix. In these cases, technically compliant results may still fail to withstand regulatory scrutiny.

Our Method Verification Gap Check evaluates whether your current subvisible particle testing strategy is scientifically appropriate, properly verified, and defensible for its intended use. This review focuses on identifying gaps in Method 1 and Method 2 verification, documentation, and justification before they become audit findings or filing questions.

By proactively addressing these gaps, teams can strengthen governance, reduce investigation risk, and support a predictable path to regulatory submission.

Validate before audit or filing exposure occurs.

Schedule a Method Verification Gap Check with Gateway Analytical to assess the defensibility of your subvisible particle methods and ensure your data package is inspection-ready.

(724) 443-1900 | in**@***************al.com

The post Method Verification Gap Check: Closing the Defensibility Gap in Subvisible Particle Testing appeared first on Gateway Analytical - Analysis Solutions.

For complex formulations, a “technically compliant” compendial method may be deemed indefensible if method suitability isn’t properly established. We provide the technical rigor to evaluate:

Method 1 and 2 Verification Decision Points: Determining the most defensible analytical path for your specific matrix.

Complex Matrix Compatibility: Addressing the technical limitations of standard testing for non-standard modalities.

Technical Documentation: Preparing regulatory-ready records that justify your particulate control strategy.

Choose Gateway Analytical as your partner for expert technical support as you navigate the 2026 landscape, ensuring your subvisible data is defensible remains essential to protecting your filing timeline.

(724) 443-1900 | in**@***************al.com

The post Beyond USP <788> Compliance: Is Your Method Suitability Defensible for 2026? appeared first on Gateway Analytical - Analysis Solutions.