Formulation Development Experience For Effective Particle Identification

By Jörg Müller, Business Development Manager

The presence of particulate matter in biopharmaceutical products is far more than a minor obstacle — it is a critical signal of product instability that can disrupt manufacturing, compromise quality, and delay patient access. Rapid and accurate identification of these particles is essential for preserving batch integrity, safeguarding patient safety, and maintaining regulatory compliance. Understanding how complex formulations — including interactions between active ingredients, excipients, and primary packaging — respond to environmental stressors is central to effective particle analysis.

By combining advanced analytical techniques such as SEM-EDX and FTIR with deep formulation expertise, researchers can determine whether particles are intrinsic degradation products or extrinsic contaminants. This integrated approach transforms particle analysis from a reactive troubleshooting exercise into a proactive quality control strategy. Swift identification supports rapid root-cause analysis, prevents costly out-of-specification results, and strengthens long-term product stability. Discover how streamlined analytical workflows can enhance confidence and efficiency in biopharmaceutical development.