Harmonization: Standardized Raw Material Verification for Faster Onboarding, Technology Transfer, and Testing Consistency
CDMOs and contract testing laboratories sit at the center of the cell and gene therapy raw materials ecosystem. They must support multiple sponsors, qualify diverse raw materials, implement customer-specific methods, manage supplier changes, and generate reliable data under demanding timelines.
Biothentix provides a standardized, multiplexed approach to raw material identity verification and characterization. By using a common analytical platform, fit-for-purpose reagent kits, and automated software analysis, Biothentix helps CDMOs and CTLs reduce method-development burden, accelerate onboarding, and generate consistent, traceable results across suppliers, customers, and testing sites.
The CDMO Challenge
Cell and gene therapy programs often enter technology transfer with raw material control strategies that are incomplete, fragmented, or highly specific to the originating sponsor. Incoming material verification may rely on supplier Certificates of Analysis, limited compendial tests, historical performance, or multiple disconnected analytical methods.
For CDMOs and CTLs, this creates operational complexity. Each new sponsor, supplier, material, or process change may require additional method evaluation, troubleshooting, documentation, and communication across multiple organizations.
Biothentix helps simplify this workflow by converting complex biological raw material characterization into standardized analytical fingerprints that can be implemented reproducibly across sites and users.
How Biothentix Supports CDMOs and CTLs
Verify Incoming Raw Materials
Biothentix reagent kits are designed to measure multiple raw material attributes in a single standardized workflow. The resulting analytical fingerprint can be used to compare incoming lots against a qualified reference, verify expected material identity, and detect meaningful lot-to-lot differences before those materials enter development or manufacturing workflows.
Reduce Method Development Burden
Traditional raw material characterization may require multiple single-analyte assays, custom methods, or orthogonal analytical workflows. Biothentix consolidates multi-attribute testing into a standardized multiplex format, helping laboratories reduce analytical complexity while preserving flexibility to measure the attributes most relevant to each material or process.
Streamline Technology Transfer
When sponsors, suppliers, CDMOs, and CTLs use the same analytical platform and kit-defined workflows, raw material verification becomes easier to transfer and interpret. Biothentix supports a shared analytical language that can reduce ambiguity during process transfer, supplier qualification, and manufacturing scale-up.
Customer-Specific Testing Strategies
Because Biothentix kits are fit-for-purpose, users can define the cytokines, growth factors, enzymes, proteins, or other material attributes most relevant to a sponsor’s process. Once built, the kit can be run using the ArrayView™ platform and automatically analyzed and interpreted by InDevR’s 21 CFR Part 11-ready software.
This enables CDMOs and CTLs to offer customer-relevant raw material verification without rebuilding the analytical workflow from the ground up for every program.
Why It Matters
Faster Onboarding
Standardized kit-based workflows help laboratories implement raw material verification more efficiently for new sponsors, suppliers, and materials.
Improved Testing Consistency
A common analytical platform helps reduce variability across operators, laboratories, suppliers, and customer programs.
Stronger Technology Transfer
Shared raw material fingerprints can improve communication between sponsors, suppliers, CDMOs, and contract testing sites.
Reduced Operational Risk
Earlier detection of raw material differences can help reduce troubleshooting burden, rework, investigations, and avoidable process delays.
Traceable Digital Results
Automated software analysis supports consistent interpretation, structured documentation, and quality-system-ready reporting.
Fit-for-Purpose Kits. Standardized Results.
Biothentix kits are designed around the raw material attributes that matter most to your process, then converted into standardized, software-defined workflows for reproducible testing across sites and users.
Users can define the cytokines, growth factors, enzymes, proteins, or other material attributes most relevant to their process, material, or quality-control strategy. InDevR applies its reagent kit build process to create a fit-for-purpose multiplex kit, with typical build times of less than six weeks.
Once built, the customized kit can be run using the ArrayView™ platform and a standardized workflow, with data automatically analyzed and interpreted by InDevR’s 21 CFR Part 11-ready software.
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