Particle identification for biopharmaceuticals
The observation of visible and sub-visible particles can result in stagnation of the drug development or batch release process. At Coriolis Pharma we have both the experience and the capacity to determine the identity and possible origin of particulate matter in your (bio)pharmaceutical drug products which is crucial for troubleshooting and root-cause analysis. Our experts can analyze your samples with minimal lead time and deliver results right from the lab bench, so you can resolve the underlying cause of particle formation.
We provide all our services with the highest quality standards and support samples up to biosafety level 2 (S2 / BSL2) classification with this service.
Appearance of particles
Particles in the visible and subvisible size range can appear in (bio)pharmaceutical samples and drug products during all stages of development and even after market approval. The presence of particles can indicate an insufficient stability of the active pharmaceutical ingredient or issues with the production process and can negatively influence the safety and efficacy of the therapy.
directly derive from the active pharmaceutical ingredient (API) e.g., due to an insufficiently stable therapeutic protein or from primary packaging (intrinsic particles)
be related to formulation excipients e.g., degradation products (inherent particles)
be introduced during the production process e.g., during pumping or filtration steps or by personnel (extrinsic particles)
Troubleshooting with rapid particle identification
Determining the identity and possible origin of particulate matter in (bio)pharmaceutical drug products is crucial for troubleshooting and root-cause analysis and, thus, often very time-critical. Coriolis experts can analyze your samples within a matter of days, if required, so you can resolve the underlying cause of particle formation as quickly as possible.
We can select the most suitable approach for your particular analytical challenge, whether following a standardized in-house workflow or a custom-tailored solution.
Webinars and Publications
Dominik Brandstetter, Constanze Helbig, Kentaro Osawa, Hiroyuki Minemura, Yumiko Anzai, Tetsuo Torisu, Susumu Uchiyama, Tim Menzen, Wolfgang Friess, Andrea Hawe
Srivalli N Telikepalli, Michael J Carrier, Dean C Ripple, Greg Barnett, Ashwinkumar Bhirde, Donna Bolton, George M Bou-Assaf, Erica Ferrari, Scott Leigh, Sophia Levitskaya-Seaman, Tim Menzen, Felix Nikels, Anna Riley, Miguel Saggu, Neha Sahni, Eric Vernooij, Klaus Wuchner