Bionter
About Bionter
The startup develops analytical testing devices that utilize combination light obscuration technology for sub-visible particle testing, which is essential for ensuring patient safety in parenteral preparations. Their services support stability testing, drug formulation, and in-process control during manufacturing, enabling clients to meet regulatory requirements and enhance product quality.
<problem> Parenteral preparations require rigorous sub-visible particle testing to ensure patient safety and meet stringent regulatory requirements. Traditional analytical testing methods can be limited in their ability to accurately and efficiently detect and characterize these particles, impacting drug formulation, stability testing, and in-process control during manufacturing. </problem> <solution> The startup provides analytical testing devices leveraging combination light obscuration (LO) technology for precise sub-visible particle analysis. Their devices enable comprehensive characterization of particulate matter in parenteral preparations, supporting enhanced product quality and patient safety. By offering advanced analytical capabilities, the startup empowers pharmaceutical manufacturers to optimize drug formulation, conduct thorough stability testing, and maintain robust in-process control throughout the manufacturing lifecycle. This technology ensures compliance with regulatory standards and facilitates the development of safe and effective injectable medications. </solution> <features> - Combination light obscuration technology for accurate sub-visible particle detection and sizing - Automated particle counting and characterization - Real-time data analysis and reporting - Compliance with USP <788> and other relevant regulatory guidelines - Integrated software for data management and audit trails </features> <target_audience> The primary customers are pharmaceutical manufacturers, compounding pharmacies, and research laboratories involved in the development, production, and quality control of parenteral drug products. </target_audience>
What does Bionter do?
The startup develops analytical testing devices that utilize combination light obscuration technology for sub-visible particle testing, which is essential for ensuring patient safety in parenteral preparations. Their services support stability testing, drug formulation, and in-process control during manufacturing, enabling clients to meet regulatory requirements and enhance product quality.
Where is Bionter located?
Bionter is based in Riehen, Switzerland.
How much funding has Bionter raised?
Bionter has raised 3850000.
- Location
- Riehen, Switzerland
- Funding
- 3850000
- Employees
- 4 employees
- Major Investors
- Dynamk Capital