Using a simple exchange of images from your flow-imaging microscopy or backgrounded membrane imaging platform, we can develop and test a Fingerprint of your biologic drug product. Our service includes a comprehensive report detailing your test results and a graphic representation of the Fingerprint. This Fingerprint is transferrable to any ParticleSentryᴬᴵ system.
We have testing protocols to replicate pH shock, light, shaking upset, pump-induced and other physical stressors that can impact biologic formulations. Again, with a simple exchange of images from your flow-imaging microscopy or background membrane imaging platform, we can develop a Fingerprint and test your biologic drug under normal and stressed conditions. This data will provide information to select the best formulation for pre-clinical research. Fingerprint(s) developed are transferrable to any ParticleSentryᴬᴵ system.
Once a Fingerprint has been developed, we can easily compare images from other production lots. The comparison identifies shifts in morphological and textural characteristics of particles in different samples. This service includes a comprehensive report detailing your results and includes graphic images of the Fingerprint and comparison of batch results.