Bioanalytical services
From biomarker discovery to market-ready diagnostics. Biocult supports pharma, biotech and diagnostic companies with custom immunoassay development, assay optimization, validation and manufacturing transfer to bring reliable IVD solutions to market.
Our bioanalytical services
From early-stage feasibility studies to commercial production, we provide tailored solutions for every stage of IVD development.
1. De-novo assay development
We develop custom immunoassays based on your biomarker, application and performance requirements. From feasibility assessment and critical reagent sourcing to assay development, we help translate biomarker concepts into reliable diagnostic tests.
2. Assay optimization
Improve assay performance with targeted optimization. We help address challenges involving specificity, reproducibility, robustness and analytical performance to support reliable results and future clinical applications.
3. Platform migration & scale-up
Move assays between platforms while maintaining performance and supporting scalability. We help transition manual assays to automated analyzers and migrate research-use-only (RUO) assays, including MSD and Luminex formats, towards validated IVD applications.
4. Verification & validation for pharma-related IVDs
We support assay verification and validation to demonstrate that diagnostic tests meet predefined performance requirements. Our approach considers analytical performance, intended use and applicable regulatory requirements for pharma-related IVDs, including companion and complementary diagnostics.
VERIFICATION AND VALIDATION
5. Manufacturing &
commercialization
Prepare your assay for production and market introduction. We support contract manufacturing for validation studies and initial launches, alongside partnerships that can facilitate larger-scale production and commercialization.
MANUFACTURING & COMMERCIALIZATION
From biomarker to market-ready IVD
Feasibility & proof of concept:
Assess technical feasibility, biomarker suitability and critical materials.
Development & optimization:
Establish and refine assay performance for the intended application.
Verification & validation:
Generate performance evidence in line with defined requirements and applicable regulations.
Transfer & scale-up:
Prepare assays for automated systems and manufacturing.
Manufacturing & market introduction:
Support production and commercialization through our capabilities and partners
Our services can be tailored to your project’s stage, objectives and technical requirements.
Immunoassay development across clinical stages
Every stage of drug and biomarker development requires fit-for-purpose analytical methods. Biocult helps pharma and biotech companies adapt assays as projects progress.
- Early development: Exploratory assays, feasibility studies and proof-of-concept testing to investigate biomarker performance.
- Clinical development: Assay optimization and validation to support reliable biomarker data and clinical decision-making.
- IVD transition: Transfer research-use-only assays into validated diagnostic formats, including companion and complementary diagnostics where applicable.
- Commercialization: Manufacturing preparation, scale-up and collaboration with partners to support market introduction.
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Let’s make something great together. Feel free to contact us for more information via the contact form.
Frequently asked questions
Bioanalytical services support the development and evaluation of analytical methods used to measure biomarkers and demonstrate assay performance. For IVD development, these services can include feasibility studies, immunoassay development, optimization, verification, validation and manufacturing transfer.
Yes. Biocult develops custom immunoassays based on project-specific requirements, including the biomarker, intended application, assay format and required performance characteristics.
Yes. We help improve existing assays by addressing challenges such as specificity, reproducibility, robustness and platform compatibility.
Biocult supports the transition of research-use-only assays towards validated IVD applications, including platform migration, assay optimization and verification and validation. The approach depends on the assay, intended use and applicable regulatory requirements.
Yes. Biocult offers manufacturing support for validation studies and initial launches, with partner networks to help facilitate larger-scale production and commercialization.