Subvisible Particle Analysis: Ensuring Quality from Lab Bench to GMP

Regulatory requirements, method validation and variability control for subvisible particle analysis from R&D through to GMP compliance.

November 18th 2025

16:00pm (CET) / 10:00am (ET)

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OVERVIEW

The quantification of subvisible particles is a critical aspect of ensuring the safety, efficacy, and overall quality of pharmaceutical products. These particles may originate from extrinsic sources, e.g., environmental contaminants or manufacturing equipment, or be intrinsic to the formulation itself. Their presence can pose significant risks to patients, including immunogenic responses, infusion-related reactions, or diminished therapeutic efficacy. Consequently, regulatory authorities expect routine monitoring and control of subvisible particulate matter as part of pharmaceutical quality control, with defined acceptance criteria for particle size and concentration.

In some cases, subvisible particles are an inherent part of the product. In these instances, precise characterization of particle size distribution, morphology, and concentration is essential to ensure product consistency, biological performance, and patient safety. Any temporal changes in particle attributes may indicate physical instability or degradation processes, making subvisible particle analysis a sensitive and informative stability-indicating parameter. Accordingly, having a robust and precise analytical method for subvisible particle characterization is critical at all stages of the pharmaceutical product lifecycle, spanning from early development to release of clinical or commercial batches.

In this webinar, we will present a case study highlighting the challenges involved in establishing a precise method for (inherent) subvisible particle analysis and its transition from development in an R&D setting to validation in a GMP-compliant environment. We will discuss regulatory requirements, workflows, and quality considerations involved in moving from R&D to GMP. The case study will highlight sources of result variability—such as the selected analytical method, sample preparation procedures, equipment, operators, or combinations thereof – and offer guidance on how to control these factors and improve method performance.

Addressed Challenges

01Meeting different regulatory expectations for analytical methods in R&D versus GMP, including workflows, documentation standards, and audit readiness requirements.

02Managing the extensive documentation burden during experimental planning, which is time-consuming but essential to achieving successful method validation outcomes.

03Controlling result variability introduced by differences in equipment performance, sample preparation procedures, and operator technique across testing environments.

04Addressing measurement uncertainty that causes significant misestimation of particle concentrations when samples require dilution prior to analysis.

WHAT YOU WILL LEARN

01Learn the essential regulatory requirements for initiating contract GMP testing, including responsibility definitions and formal laboratory qualification.

02Understand how quality requirements differ between R&D and GMP environments when transitioning analytical methods through the development lifecycle.

03Learn the regulatory requirements for validating analytical procedures used in the quantification of subvisible particles in pharmaceutical products.

04Identify the most common sources of variability in subvisible particle analysis and explore proven strategies to control and mitigate their impact.

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SPEAKERS

Dr. Bodo Brocks

Quality Unit Manager

Dr. Bodo Brocks holds a diploma in Technical Biology from the University of Stuttgart and earned his doctorate in the field of phage display and therapeutic antibodies in a collaboration with Boehringer Ingelheim. From 1999 t0 2021 he has held different positions at the former German biotech flagship MorphoSys AG. As Director of Analytical Development, Head of QC, and Director of QA we was deeply involved in research, clinical development and market launch of therapeutic antibody products. Since October 2021, he has been Head of Quality at Coriolis Pharma and is responsible for the global quality management under R&D and GMP.

Dr. Sergey Sotnikov

Principal Scientist GMP

Dr. Sergey Sotnikov holds a diploma in Pharmacy from the Medical State University in Moscow (2011) and completed his doctoral studies in Biology at Ludwig Maximilian University of Munich in 2014. Following his PhD, he spent four years as a Senior Scientist at a biotech start-up, where he was responsible for developing new analytical methods for quality control and providing analytical support for production and formulation development programs. Since 2019, Sergey has been working at Coriolis Pharma in the GMP Analytics department, where he has held several roles including Project Manager, Group Leader, and currently Principal Scientist. His work focuses on the implementation and validation of analytical methods, batch release testing, and stability studies. Most recently, he has been involved in the expansion of GMP services at Coriolis Pharma, leading the implementation of new analytical methods and serving as a subject matter expert in QC and GMP-related topics.

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