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

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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 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.

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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 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 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 Analysis Solutions.

Resolving a batch hold and protecting your filing timeline requires more than a “test result”; it requires chemical identification that withstands regulatory scrutiny. Gateway Analytical provides the scientific authority required to resolve these investigations. Our Ph.D.-led team moves beyond standard pass/fail to deliver definitive identification and actionable root-cause insight.

Analytical Workflows for Forensic Investigations

We leverage a specialized suite of instrumentation specifically configured to deliver regulator-ready reports for complex matrices:

• LC-MS/MS & QTOF-MS: We provide precise chemical identification of unknown compounds and characterization of reactive byproducts where standard chromatography fails.
• GC-MS: We pinpoint volatile and semi-volatile extractables, identifying the specific chemical contributors to particulate formation.
• SEM-EDS & Micro-Raman Spectroscopy: We deliver high-resolution morphological and chemical characterization to distinguish between visible and subvisible particles at the source.

Contamination Tracing & Regulatory Defense

A pass/fail result is rarely enough to satisfy a deep-dive BLA review or a Pre-Approval Inspection (PAI). Gateway provides the analytical depth to pinpoint the exact source of a deviation—ensuring your investigation package survives governance and demonstrates a total command of your particulate control strategy.

Do not let an unidentified particle escalate into a prolonged disruption. Trust Gateway Analytical for immediate, expert support. Reach out today for a priority consultation:
(724) 443-1900 | in**@***************al.com

The post Forensic Particulate Investigations: Navigating Quality Control Obstacles appeared first on Analysis Solutions.

Our Unified Approach to Drug Delivery & Analytical Defensibility

We were proud to showcase how combining advanced elastomeric closure components with robust analytical strategies strengthens both product performance and regulatory confidence alongside our parent company Aptar Pharma. Throughout the week, discussions centered on how developers can proactively address particulate and CCI risks across increasingly complex delivery systems.

Key focus areas included:

Visible Particulate Characterization

Attendees explored investigative workflows for identifying unknown particulates using SEM-EDS and micro-Raman — crucial for batch-release confidence and for resolving high-risk events.

Subvisible Particle Testing for Emerging Modalities

Teams working with biologics, LNPs, CGT products, and mRNA therapies engaged in deep discussions on low-volume method verification, USP <788>/<787> strategies, and establishing scientifically appropriate bridges for new modalities.

Container Closure Integrity (CCI) Strategies for Complex Systems

With delivery platforms evolving rapidly, visitors were eager to learn how CCI testing integrates into system-level optimization and long-term risk mitigation.

Technology Lab Demonstrations: A Hands-On Look at Advanced Tools

Our live Technology Lab sessions, delivered in partnership with Lighthouse Instruments and PTI, provided attendees with a firsthand look at the CCI and inspection technologies shaping the next generation of compliant, cGMP-aligned testing strategies.

These demonstrations highlighted how leading developers leverage these tools to:

· Improve detection sensitivity for DIPs (Difficult-to-Inspect Products)

· Strengthen risk-based particulate and CCI assessments

· Replace operator-dependent inspection steps with instrument-driven confidence

· Generate defensible data packages that align with tightening global expectations

Themes That Defined PDA Week 2026

Across hundreds of conversations, several themes stood out:

· Regulatory expectations are accelerating faster than ever

· Scientific defensibility, not minimum compliance, is the new standard

· Complex modalities demand new approaches to particulate and CCI challenges

· Integrated device–analytics strategies are essential for de-risking development

We appreciated every opportunity to help teams think through next-steps for their 2026 programs.

Let’s Continue the Conversation

Thank you to everyone who visited us in Denver, whether at the booth, the Technology Lab, or in one of the conference sessions. We look forward to building on the connections made throughout the week.

If you were unable to attend, or if you’d like to continue discussing your particulate or CCI strategy:

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

Now is the ideal time to prepare your analytical roadmap for 2026.

Gateway Analytical — Scientific Clarity for Complex Problems.

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We’re here live at PDA Week 2026 in Denver, where global leaders in sterile manufacturing, quality, and regulatory science are exploring the technologies and analytical strategies shaping the future of injectable product safety. If you’re attending, make sure to stop by booth 204 to connect with the team from Gateway Analytical. As the regulatory landscape tightens and expectations for data defensibility grow, this year’s meeting offers an unparalleled opportunity to sharpen your technical expertise in visible particulates, subvisible particle testing, and Container Closure Integrity (CCI).

Throughout the week, our experts are leading discussions on how development teams can prepare for emerging expectations in 2026 and beyond. Whether evaluating DIP (Difficult-to-Inspect Product) strategies or building scientific bridges for complex modalities, our team is here to help attendees:

· Strengthen particulate and CCI readiness

· Build scientifically defensible data packages

· Navigate evolving USP and global regulatory standards

· Resolve particulate “unknowns” with forensic precision

· Optimize inspection strategies for challenging delivery systems

Stop by Booth 204 to explore how our analytical workflows support confident, compliant decision-making across the product lifecycle.

Experience the Technology Lab — Live at Booth 204

Don’t miss the opportunity to see advanced instrumentation from our partners Lighthouse Instruments and PTI in action. These live demonstrations show how cutting-edge CCI and inspection technologies integrate directly into cGMP-aligned testing strategies, enabling teams to:

· Detect and address closure performance issues

· Support risk-based particulate and CCI analysis

· Improve detection sensitivity for DIPs and novel modalities

· Generate higher-quality, defensible analytical data

If you want to experience best-in-class tools used by leading global developers, the Technology Lab is a must-see.

Let’s Connect While You’re Here

Before you leave the exhibit hall, make sure you have a clear plan for your next analytical milestone. Our team is available onsite for:

· Private strategy sessions

· Method Verification Gap Checks

· Particulate testing roadmap reviews

· CCI strategy consultations

We look forward to collaborating with you here in Denver at Booth 204!

Gateway Analytical — Scientific Clarity for Complex Problems.

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Gateway Analytical is proud to attend the 2026 PDA Annual Meeting Week in Denver, Colorado alongside our parent company, Aptar Pharma. Together, we will highlight how integrated device components and analytically robust data packages create a solid foundation for safe, compliant, and innovative drug products.

As regulatory expectations evolve, development and QC teams face growing demands for defensible particulate and CCI data, especially when working with new modalities, novel delivery systems, and Difficult-to-Inspect Products (DIPs). Ensuring your analytical strategy is built to withstand intensified scrutiny is essential for success in 2026 and beyond.

Bridging Device Innovation and Analytical Defensibility

From early development through commercial deployment, regulatory expectations surrounding particulate control and container closure performance continue to increase. During PDA Week, our team will focus on how to strengthen strategies in key risk areas:

Visible Particulate Characterization

Through advanced forensic techniques, including SEM-EDS and micro-Raman spectroscopy, we help teams investigate, identify, and resolve particulate “unknowns” that could otherwise lead to batch holds or release delays.

Subvisible Particle Testing & Scientific Bridging

As CGT, LNP, and mRNA therapies introduce new challenges, low-volume method verification and scientifically appropriate bridging strategies become essential. Our approach preserves precious API while generating high-quality, defensible data.

Container Closure Integrity (CCI) Testing

Ensuring functional suitability across the full container-closure-delivery system is critical for regulatory approval. We support teams in evaluating closure performance using cGMP-aligned CCI technologies and risk-based methodologies.

Unified Solutions for Complex Modalities

Our combined expertise—spanning analytical chemistry, materials science, and elastomeric component engineering—equips drug developers with actionable solutions for:

· System-Level Optimization: Evaluating device and closure interactions in real-world patient environments.

· Complex Modality Testing: Tailored workflows for CGT, LNP, and mRNA programs requiring low-volume and high-sensitivity analytical methods.

· Forensic Root-Cause Resolution: Rapid identification of particulate contaminants to turn a batch hold into a defensible path forward.

See Our Technology Lab at PDA Week

Don’t miss your opportunity to experience live instrument demonstrations featuring industry-leading tools from Lighthouse Instruments and PTI. These technologies form the backbone of robust CCI and particulate-inspection strategies adopted by leading pharma and biotech companies worldwide.

Whether you’re refining a USP <788>/<787> testing strategy, building a DIP-resilient inspection approach, or preparing for regulatory submission, our team is ready to help you accelerate your readiness.

Connect With Us in Denver – PDA WEEK – DENVER, CO – MARCH 2026

Don’t wait for an inspection to find a gap in your analytical strategy. Start preparing for your 2026 analytical strategy today.

Gateway Analytical — Scientific Clarity for Complex Problems.

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