Build Your Biothentix Kit
You Define the Analytical Targets. InDevR Builds the Reagent Kit and Optimizes the Assay for Your Workflow
Fit-for-Purpose Reagent Kits Powered by a QC -Ready Platform
Whether reducing QC burden by combing multiple ELISA or Western Blot assays, or gaining greater insight into complex formulation variability, we make it easy for you to implement multiplexed assays that give you the data you need. You define the desired analytical targets, sample matrix, and intended use, and InDevR develops a fit-for-purpose multiplex assay around those requirements.
The outcome is a customer-specific Biothentix™ reagent kit, assay protocol, and standardized analysis workflow that your laboratory can implement on the ArrayView platform — and continue purchasing directly from InDevR as needed.
The Biothentix Difference
This approach combines the flexibility of custom assay development with the consistency and convenience of an ISO 13485 QMS-manufactured reagent kit that is analyzed using the ArrayView imager and associated 21CFR Part 11-ready software.
- Customer-defined targets: Build the panel around your analytical needs
- Multiplex efficiency: Measure multiple targets (up to 50) simultaneously using a single standardized workflow.
- Expert development: InDevR manages reagent evaluation, microarray design, optimization, and performance assessment.
- Customer-specific deliverable: Receive a multiplex reagent kit with a dedicated SKU, optimized assay protocol, and standardized analysis workflow.
- Continued kit availability: Purchase additional customer-specific kits directly from InDevR following successful development.
- Quality-system manufacturing: Kits are manufactured under InDevR’s ISO 13485-certified quality management system.
- Standardized data analysis: Automated image acquisition and 21 CFR Part 11-compatible software support consistent, traceable results.
- Established assay development experience: Benefit from more than two decades of InDevR experience developing custom biological assays.
Biothentix complements established functional, phenotypic, chemical, and orthogonal methods by adding standardized identity and quantity measurements across multiple biological targets.
How it Works
Define the Application
You tell us the analytical targets, sample type(s), intended application(s), anticipated concentration ranges, and decisions the assay should support. Then, collaborate with InDevR to discuss and finalize the assay performance requirements.
InDevR Develops the Assay
Our Expert Services team evaluates candidate reagents, establishes the microarray configuration, and optimizes the multiplex workflow.
Performance Is Assessed
The assay is characterized using appropriate standards and, when available, customer-designated samples representing the intended application.
Your Kit Moves into Manufacturing
Following successful development, the customer-specific reagent kit is transferred into InDevR manufacturing under an ISO 13485-certified quality management system.
Designed Around Your Cell and/or Gene Therapy Application
Biothentix assays can be developed to address analytical needs across cell and gene therapy research, process development, manufacturing, and quality workflows.
Raw Materials Characterization: Measure multiple attributes of complex biological raw materials to establish identity, compare lots, evaluate suppliers, and investigate unexpected variability.
Cell Culture Media Analysis: Develop targeted panels for growth factors, cytokines, proteins, and other critical components used in cell expansion, maintenance, and differentiation.
Cell State and Process Biomarkers: Measure multiple proteins associated with cell state, process response, differentiation, stress, or cell damage in a single assay.
Process Development and Comparability: Generate standardized multiplex data to compare formulations, process conditions, production runs, scales, laboratories, or manufacturing sites.
Technology Transfer and Harmonization: Implement the same kit-defined analytical workflow across developers, suppliers, CDMOs, manufacturing sites, and contract testing laboratories.
Consolidation: Many cell and gene therapy workflows depend on several related biological measurements. Developing and maintaining separate single-analyte assays can require substantial time, specialized expertise, and ongoing reagent management. Biothentix can be used to consolidate selected targets into a standardized multiplex workflow.
What We Need to Get Started
A productive initial discussion typically includes:
- A list of the analytical targets you would like to measure
- The intended sample type or matrix
- Expected target concentration ranges, if known
- The purpose of the assay and decisions the results will support
- The desired analytical performance characteristics
- Current analytical methods you utilize and their limitations
- Confirm availability of standards and representative samples
- Expected testing volume and anticipated frequency of use
You do not need to have every technical detail finalized. InDevR will help assess the proposed panel, identify feasibility risks, collaboratively discuss performance targets, and define an appropriate development plan.
Frequently Asked Questions
Can we select our own analytical targets?
Yes. Biothentix projects begin with targets defined by the customer. InDevR then assesses the feasibility of measuring those targets together in the intended sample matrix.
Is every proposed target suitable for a Biothentix assay?
No. Feasibility depends on factors including: reagent availability and specificity, expected concentration, sample matrix, required sensitivity, and compatibility with the other targets in the panel. The feasibility phase is designed to identify potential roadblocks before full assay development. [ED3.1]
Can our own samples be used during development?
Yes. Customer-designated samples can be incorporated into performance assessment when appropriate samples are available and are highly encouraged, as representative samples generally improve the relevance of assay optimization.
What is the final deliverable?
The intended outcome is a customer-specific multiplex reagent kit with a dedicated SKU, an optimized assay protocol, a standardized analysis workflow, and documented performance appropriate to the agreed project scope.
Can we purchase additional kits after development?
Yes. Following successful development and manufacturing transfer, the customer-specific kits are manufactured by InDevR under its ISO 13485-certified quality management system and can be purchased directly from InDevR for continued use.
Is the resulting assay validated?
The standard development process includes assay optimization and performance assessment to verify the assay design meets the intended performance targets. Formal validation f[ED4.1]or a specific application/use case is the responsibility of the end user, and InDevR is available to provide input on validation-related questions and concerns.
Have a Target Panel in Mind?
Tell us what you want to measure, the samples you need to analyze, and how the results will be used.
Our Expert Services team will assess whether Biothentix is a good fit and recommend an appropriate path from feasibility through routine kit supply.
For Research Use Only. Not for use in diagnostic procedures.
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6035 Longbow Dr., Suite 102, Boulder, CO, 80301