Injectable biologics and complex parenterals face increasing pressure when subvisible particle counts rise, shift, or behave inconsistently. These events can trigger quality, regulatory, and stakeholder concerns; extend investigations; raise comparability questions; and slow development or release timelines. In many cases, teams have data showing how many particles are present, but not what they are, what changed, or what to do next.
These issues often emerge at critical stages of the product lifecycle: during early development and method setup, when formulation behavior is still being understood; during manufacturing or process changes, when materials or conditions may introduce new particulate sources; and during stability studies, when upward trends must be explained even if specifications remain within limits. When the cause is unclear, teams may spend weeks repeating tests without gaining meaningful direction.
In this webinar, Gateway Analytical will present Flow Imaging Microscopy (FIM) as an image-based tool that complements particle-counting methods when counts alone are not enough. By adding visual and morphological context, FIM helps reduce uncertainty and supports more focused investigations. We’ll also outline a practical decision framework for when compendial counting methods are sufficient, when FIM adds value, and when confirmatory chemical or elemental techniques such as FTIR, Raman, or SEM-EDS are needed to identify the particle source.
Attendees will learn where FIM is especially useful across injectable modalities such as high-concentration protein biologics, peptides, long-chain molecules, ADCs/conjugates, and products involving fill-finish or container-closure interactions where silicone oil, glass, elastomer, or metal may be suspected. Through practical investigation playbooks, we’ll show 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.
If your team has encountered particle excursions or shifting trends that raised more questions than answers, this session will offer a practical path from counts to clarity. You’ll learn how to apply an investigation decision tree and use a feasibility-first approach to quickly determine whether FIM fits your formulation, constraints, and decision needs—so you can move forward with greater speed and confidence.
Key Learning Objectives
- Recognize the most common investigation triggers in injectable biologics and complex parenterals, where subvisible particles count alone can delay decisions.
- Apply a practical decision framework to determine when to rely on compendial counting approaches, when to add FIM for image-based evaluation, and when to escalate to confirmatory 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.
