Analysis of subvisible particles and aggregates in GMP compliance

Expert know-how in aggregate and subvisible particle analysis as a GMP compliant service

Coriolis has received cGMP accreditation by the local regulatory authority and since then we have been re-inspected by the authority and audited by several clients successfully. With a strong focus on analysis of subvisible particles (SVP) we feature the following methods in full GMP compliance:

Light obscuration (LO) (USP <787>, USP <788>, USP <789>, Ph.Eur. 2.9.19.)

  • Quantification of particles ≥ 1 μm
  • Pharmacopoeia method for the determination of subvisible particles ≥ 10 μm and ≥ 25 μm (USP, Ph. Eur.)
  • Development for Low volume method in accordance with USP <787>
  • Vast experience with high-concentration / high-viscosity formulations
  • Vast experience with ophthalmology products

Micro-Flow Imaging (MFI)

  • Quantification, characterization and visualization of particles ≥ 1 μm
  • Particle images and shape analysis
  • Customized filter development for differentiation between particles of different origin (protein, silicone oil droplets, filter shedding, etc.)
  • High sensitivity for translucent (protein) particles
  • Referred to by regulatory authorities as orthogonal method to light obscuration
  • Product-specific validation of MFI methods

Turbidity / Nephelometry

  • Quantification of turbidity according to Ph.Eur.
  • Suitable for stability studies

Typical projects involve product-specific method development and subsequent compendial method verification or method validation. Release testing or routine analysis (supporting in-use or stability studies) is performed based on established Testing Procedures.
At Coriolis we have a lot of experience in establishing the best SVP analytics for the following areas:

  • SVP for high concentration formulations
  • SVP for (standard) formulations
  • SVP for Ophthalmology products
  • SVP for in-use stability
  • SVP for Gene therapy products (BSL1 and BSL2)

Relevant Coriolis publications

Gühlke M. et al., Taking subvisible particle quantitation to the limit: Uncertainties and statistical challenges with ophthalmic products for intravitreal injection. J Pharm Sci. 2019 Nov

Weinbuch D. et al., Light obscuration measurements of highly viscous solutions: sample pressurization overcomes underestimation of subvisible particle counts. AAPS J. 2014 Sep

Hawe A. et al., Pharmaceutical feasibility of sub-visible particle analysis in parenterals with reduced volume light obscuration methods. Eur J Pharm Biopharm. 2013 Nov

Contact us

For enquiries related to GMP analytics please contact Dr. Jörg Müller

Jörg Müller