Smart ID Test for Complex Biological Materials:
Multiplexed immunoassay is 10x Faster and 60x cheaper than traditional ID verification tests, such as Western Blot. The All-in-One approach significantly reduces the QC workload and risk by simplifying the analytical tools needed.
Standardized Platform Accepted by Regulatory Agencies:
Biothentix reagent kits are manufactured in Boulder, CO under ISO 13485 certified QMS. The software is included and is 21CFR P11 ready for integration into your QC workflow. The system is built upon the VaxArray platform, which is accepted by global regulatory authorities for vaccine release.
Customized all-in-one Kits:
Each kit is designed to meet all of your critical reagent ID test needs for individual raw materials and complex formulations. Rapid release of high-impact raw materials will streamline process development and accelerate manufacturing. The same test kit can also be used for QC release testing and CoA generation for complex materials, such as cell culture media for regenerative medicine.
Secure, Encoded Results Ensures Protection of Intellectual Property:
Biothentix uses a “fingerprint” approach for generation and verification of a CoA. For proprietary formulations, incoming raw materials testing simply verifies that the fingerprint is a match, without disclosing the exact nature of each component. Advanced test kits can also be used to verify quantity and/or component integrity.
The Biothentix™ Solution
Biothentix raw materials ID verification kits combine multiplex technology with standardized QC workflows and automated software analysis to simplify and accelerate ID verification of raw materials
Key attributes include:
- Proven simplicity and integration into QC workflows
- 21 CFR Part 11 compatible software
- Standardized reagent kits manufactured under ISO 13485 quality system
- Multiplex identification and quantification of numerous biological targets simultaneously
- Less than 2-hour turnaround time
- Digital, traceable results
- Efficient and affordable custom kit development
- Single-platform workflow replacing multiple analytical methods
- Scalable deployment across suppliers, developers, CDMOs, and CTLs
Biothentix is designed to transform the QC bottleneck of releasing raw materials into a strategic advantage for process development and manufacturing. Download our whitepaper “From QC Bottleneck to Strategic Advantage” to learn more.
“In cell and gene therapy development, complex raw material and media ID testing is a persistent bottleneck that traditional methods like Western blot can’t keep pace with. Biothentix collapses the multi-component workload into a single all-in-one platform—delivering regulatory-ready identity and quantification of many targets at once, at a fraction of the time and cost of legacy methods—turning QC release from a burden into a competitive advantage. Biothentix is a much-needed step forward for streamlining development and commercial manufacturing.”
– Basak Clements, Founder of Biomatria
+1 303-402-9100
6035 Longbow Dr., Suite 102, Boulder, CO, 80301