Who we are
Lonza, ex-Roche, ex-Merck, Scientific Expert at EDQM, Prof at Uni Frankfurt, Key expert in Particle testing
General Partner Dynamk Capital, former exec VP Satorius
Former CEO, COO Lonza
Professor at University of Denver, key expert in Particle testing
What we believe in
We have three simple values. We share these values amongst ourselves. We also share these values with those we partner and do business with.
what we are working on
Particles are considered potentially critical for patient safety. Sub-visible particle testing is mandatory for any parenteral preparation and is being used for stability testing, drug formulation and process development, and IPC testing during manufacturing.
Current light obscuration technology needs a large (25ml) sample to test, requires multiple manual handling steps, and destroys the sample in the process.
Consequently it is not possible to repeat testing, or do consecutive investigative analysis in case of particulate findings or perform other tests with the identical sample. The significant volumes needed lead to significant cost. Moreover pooling of units with smaller volume bears the risk of contamination and false positives.
Therefore the current method is especially challenging for rare drugs, biologics, cell and gene drugs.
Any dried product (such as lyophilisate) must be reconstituted prior testing and prior use (e.g., with Water for Injection), to ensure the dried material is fully dissolved (patient safety)
“Reconstitution” is mentioned across various regulations (EP, USP, ICH) and is tested for release testing, stability testing, and formulation and process development. Reconstitution time is a critical drug product quality attribute as changes in formulation, product manufacturing processes, sites or equipment can change cake morphology, specific surface are, crystallinity, wettability etc. which in turn can significantly impact reconstitution time
The current testing procedure is manual: The United States Pharmacopeia (USP) defines the reconstitution endpoint but not a procedure or apparatus for reconstitution. Operators add diluent, swirl and decide themselves when material is dissolved, and record time. The endpoint of reconstitution as determined by human operators by eye obviously provides significant variability.