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Image-based particle analysis system: Micro-Flow Imaging

Size, size distribution, shape and morphology combined in one instrument

Protein aggregation is a key challenge in the development of biologic formulations because it has crucial impact on product quality in terms of efficacy and immunogenicity. In order to characterize aggregates in a biopharmaceutical product accurately, information about the size, size distribution, shape and morphological characteristics are crucial. Sub-visible particulates in the size range of 0.1–10 microns have shown strong potential to be immunogenic, but are not precisely monitored by currently employed technologies. Micro-flow imaging technology is the only one that provides the whole dataset of information required in one instrument. For this reason, the FDA requires integration of MFI technology into Pharmacopeia methods (USP chapter <1787> Measurement of sub-visible particulate matter / General information).

Solvias offers a broad spectrum of particle characterization techniques (illustrated in Figure 1). Each technique has its own limitations based on detection method and properties of the product and therefore delivers only a part of information required. In order to get the whole picture regarding particle characterization, regulatory authorities require from manufactures that not only one technique is used but multiple orthogonal methods are applied to span the entire size range. Micro-flow imaging technique delivers not only data about particle size, size distribution and concentration but also image-based information about particle shape and morphology.

MFI is a key technology for particle characterization. Compared with light obscuration that has been conventionally used for sub-visible particle testing (USP chapter <1787>) and conventional light microscopy, MFI technology offers the following key advantages:

  • Analysis of smaller particles (customers need analysis of particles as small as possible)
  • Images: inherent, intrinsic, extrinsic particles are distinguishable
  • Analysis of higher viscose solutions possible
  • Analysis of opalescent solutions possible

In addition to size, size distribution, shape, morphology supplied by conventional microscopy, MFI provides:

  • statistically relevant data
  • high sample throughput due to short analysis time per sample (< 3 min per sample)
  • quantitative analysis (the complete sample content can be analyzed)

The following range of application for MFI are offered by Solvias:

  • Biopharmaceuticals, biosimilars and large molecules: inherent particles generated by aggregation formation from product components
  • All liquid samples in prefilled syringes and vials: detection pf intrinsic silicon oil droplets and capability to distinguish them from other particulate matter
  • QC diagnostics (foreign particles in the sub-visible size range): USP <788> commonly by LO (light obscuration), but this technology provides limited information: size and size distribution only. MFI delivers image-based information.
  • Stability studies and shelf-life simulations in order to monitor aggregation formation

Laboratories of the Solvias Group work closely together, in order to provide specific analytical packages based on customers’ needs. This functional network enables us to provide high-quality analytical data delivered on time.

Figure 1: Particle characterization methods at Solvias
MFI: micro-flow imaging; AF4: asymmetrical flow field-flow fractionation; DLS: differential light scattering; SEM: scanning electron microscopy; TEM: transmission electron microscopy; LM: light microscopy; AUC: analytical ultra-centrifugation; SEC: size exclusion chromatography; LO: light obscuration; Visible. Visible particles analysis

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