From EV Discovery to clinical readiness

Extracellular vesicles translation often requires capabilities that extend beyond a single laboratory or organization. At Tides Bio, we support EV projects across the translation journey — from early feasibility assessment to technical validation, industrialization and clinical readiness.

By leveraging our LinkEV model, we combine EV expertise with access to complementary CRO, CDMO, IVD, clinical and regulatory capabilities, helping projects connect the right expertise at the right stage.

Our goal is to help transform scientific innovation into robust, scalable and clinically relevant solutions.

A modular path to translation

Not every EV project follows the same path.

Our capabilities can be combined into focused modules, development packages or broader translation programs, depending on the maturity and objectives of each technology.

ASSESS → DESIGN → VALIDATE → SCALE → TRANSLATE

You can start with a single assessment, combine multiple capabilities within one development stage, or work with us across the full translation journey.

Build the support your technology needs

Whether you are assessing feasibility, planning technology transfer, validating an assay, preparing for industrialization or building clinical evidence, we can help identify the next step.

Explore our service modules and tell us where your technology is today.

Let’s talk →

Translation Readiness Assessment

Understand where your technology stands and what it needs to move forward

We assess the maturity, technical requirements and translation potential of your EV technology, identifying key gaps and defining the most appropriate next steps.

Feasibility & Technology Assessment
Technology maturity / TRL assessment, scientific and technical gap analysis, quality requirements and translation readiness.

Initial Development & Regulatory Assessment
High-level evaluation of development requirements, regulatory needs and key technical milestones.

Outcome

A clear picture of the current technology status, development gaps and priorities for the next stage.

Best suited for:
Early-stage technologies, research programs and teams planning the transition from discovery to development.

Start here if:
You need to understand where your technology stands, identify key gaps or define the right next step.

Tech Transfer Planning

Turn scientific potential into a structured development plan

We translate the initial assessment into a practical roadmap connecting technical development, validation, technology transfer, industrialization and regulatory requirements.

Tech Transfer & Industrialization Planning
Technology transfer strategy, industrialization roadmap, process requirements and critical development milestones.

Technical Validation Planning
Validation strategy, scope, methodology, acceptance criteria and testing activities required to demonstrate technical performance.

Regulatory Strategy
Regulatory pathway, initial regulatory assessment and planning of key regulatory interactions.

Outcome

A practical Translation Roadmap defining what needs to be demonstrated, when and how.

Best suited for:
Technologies with a defined use case that need a structured roadmap towards validation, transfer or product development.

Start here if:
You have a promising technology and need to define the development, validation or tech transfer strategy.

Technical & Analytical Validation

Build robust evidence around technology performance

We design and execute fit-for-purpose validation activities to demonstrate the technical and analytical performance, robustness and reproducibility of EV-based technologies.

Assay, QC & Analytical Validation
Assay and QC development, reference materials, technical and analytical validation, including accuracy, precision, repeatability, reproducibility, robustness and sensitivity / LoD / LoQ.

Sample & Stability Studies
Non-patient and reference samples, spiked or clinical samples, specimen stability, sample collection protocols and kit stability studies, including accelerated stability where appropriate.

Outcome

Reliable, reproducible and documented evidence supporting the performance of the technology and its progression towards industrialization.

Best suited for:
Technologies requiring technical evidence, analytical validation, assay/QC development or standardized performance assessment.

Start here if:
You have a defined technology or assay and need to demonstrate robust performance and reproducibility.

Industrialization & Prototyping

Move from a validated technology to a reproducible and scalable product

We support the transition from laboratory workflows to controlled, traceable and scalable production processes.

Supply Chain & Reagent Qualification
Critical reagent validation, supplier qualification, reagent benchmarking and supply continuity.

Industrialization & Prototyping
Process definition, SOP development, product design and labeling, traceability, risk assessment and integration into relevant quality systems.

Outcome

A controlled and reproducible production workflow, with the documentation and material required to support the next stages of development.

Best suited for:
Technologies moving from laboratory development towards productization, manufacturing and scale-up.

Start here if:
Your technology is technically validated and you need to establish a reproducible production process or generate pilot batches.

Clinical & Regulatory Readiness

Generate the evidence needed to move towards clinical application.

We support the transition from a validated product to clinical readiness through pre-clinical studies, clinical sample cohorts, biobanking, clinical validation and regulatory support.

Pre-clinical & Clinical Development
Pre-clinical studies, biostatistics, clinical study sizing, prospective clinical sample cohorts and representative patient sample collection.

Biobanking & Sample Management
Biobanking, sample management and specimen workflows supporting clinical development, including ISO 20387 where applicable.

Clinical Validation & Regulatory Compliance
Clinical performance assessment — including sensitivity, specificity, clinical concordance and predictive value — together with regulatory gap analysis, compliance assessment and regulatory affairs support.

Outcome

The clinical and regulatory evidence required to support the transition of an EV technology towards its intended application.

Best suited for:
Technologies approaching clinical evaluation, IVD development or regulatory submission.

Start here if:
You have a fully validated technology and need to generate clinical evidence or prepare for clinical and regulatory translation.

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