Comprehensive technology validation ensuring safety, functionality, and biocompatibility for life sciences applications.
At CSEM, biovalidation designates the process of evaluating technologies in direct contact with biological systems. This critical analysis determines how biomaterials, biosurfaces and biosensors interact with cells, organoids, tissues, and biological liquids.
Our multifactor approach assesses technology performance across multiple parameters, using advanced in vitro models that simulate physiologically relevant environments for precise compatibility evaluation. All studies are performed under controlled biosafety conditions (typically BSL-2). This approach enables a precise assessment of biocompatibility, biofunctionality, and material–biology interfaces at early stages of development.
At CSEM, multifactor technology validation brings together biological, and analytical testing to ensure that technologies perform reliably in contact with living systems. This integrated approach covers materials, devices, and biosensors, combining in vitro assays with automated systems to evaluate compatibility, functionality, and analytical robustness under physiologically relevant conditions.
By assessing multiple biological and physical parameters simultaneously, we ensure that materials, surfaces, and systems perform reliably and safely when interfacing with living matter.
Technology functionality in biological environments relies on partners’ models and protocols.
We evaluate materials and systems across multiple biological factors using advanced in vitro models that simulate physiologically relevant conditions.
Our validation assays include:
We also specialize in the biovalidation of biosensors—testing their performance directly in contact with biological materials such as cells, organoids, tissues, and body fluids. This allows us to evaluate how biosensors behave and respond under realistic biological conditions.
Our multifactor validation approach assesses sensitivity, selectivity, linearity, and reproducibility, enabling precise characterization of sensor performance within relevant biological matrices. All testing is conducted under controlled Biosafety Level 2 (BSL-2) conditions to ensure safety and reproducibility.
Assay design and validation parameters for biosensors
By integrating biological components early in the sensor development process, we help ensure that biosensors meet the stringent analytical and functional requirements of life science, diagnostic, and clinical applications. This approach bridges the gap between prototype testing and validated bioanalytical performance.
Our biovalidation data directly supports bioanalytical method development and qualification processes. Results help clients move from early validation to robust analytical methods that meet regulatory requirements for biological and diagnostic applications.
Through our multifactor validation and biosensor testing expertise, we accelerate the translation of innovative technologies into trusted, market-ready solutions.
Bioanalytical testing in BSL2 conditions
CSEM's Biosafety Level 2 (BSL2) laboratories provide controlled environments for handling biological materials. These facilities enable precise sample collection, manipulation, analysis and storage of tissues, cells, blood, urine, or saliva.
At CSEM, biovalidation services ensure safe, scalable technologies for drug development, regenerative medicine, and diagnostics. Powered by bioconvergence, we integrate biology, engineering, Digital Health, and Additive Manufacturing in order to:
Before advancing your biosystem, comprehensive validation in biologically relevant environments is essential. Here are success stories from clients who chose to rely on our expertise to minimize risks and maximize success rates.
From biosensor testing to material biocompatibility assessment, we provide the critical data you need to access your technology at early stages of development and successful product development. Get started with CSEM's biovalidation services.