Who we are
Tobias Werk
CEO
Hanns-Christian Mahler
Board
Scientific Advisor
Lonza, ex-Roche, ex-Merck, Scientific Expert at EDQM, Prof at Uni Frankfurt, Key expert in Particle testing
Reinhard Vogt
Board
General Partner Dynamk Capital, former exec VP Satorius
Mark Funk
Board
Former CEO, COO Lonza
John Carpenter
Scientific Advisor
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.
Responsibility
Our commitment to quality and safety drives our modus operandi. It also underpins our conviction that sustainability, through clear thinking and efficiency, must be central to everything we do.
Respect
We treat each other, all those we do business with, and those we seek to support, as we expect to be treated ourselves. We believe respect is the foundation that builds trust.
Revolution
Innovation that drives positive change is evolution. With efficiency and drive we seek to go one step further by delivering break-through technologies that positively disrupt and revolutionize our partners’ businesses, the lives of those stakeholders and the patients they seek to support.
what we are working on
Particle testing
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.
Reconstitution
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.
How to reach us
contact us
Bionter AG
Inzlingerstrasse 238
4125 Riehen, Switzerland
