Revolutionizing analytical testing
for the benefit of people’s health

more about us

Who we are

Tobias Werk

CEO

Inventor, PhD in Pharmaceutical Sciences, ex-Roche, Actelion/Idorsia
HCM_01_r1

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

our values

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.

our work

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.

Get in touch

How to reach us

    contact us

    Bionter AG
    Inzlingerstrasse 238
    4125 Riehen, Switzerland

    info@bionter.com