Client Challenge
A cell therapy developer needed to establish and transfer a combined potency assay demonstrating that its drug product could drive tissue-specific differentiation in a standard 3D culture model, with the method shown to perform comparably once it moved to a new testing site.
Avance Biosciences’ Solution
Avance Biosciences assessed the feasibility of a combined potency micromass assay, then transferred the qualified method into its Houston facility. The assay:
- Seeds the drug product into a collagen-coated 3D micromass culture, either untreated or treated, alongside a growth factor reference compound, to drive differentiation
- Extracts RNA from the micromass and measures expression of a tissue-specific differentiation marker gene by one-step RT-qPCR relative to a housekeeping gene
- Measures a matrix biosynthesis marker from the same micromass cultures using a colorimetric assay
- Uses a positive control to monitor assay performance for each readout
Project Overview
Avance first ran a feasibility study to confirm the micromass generation and harvest procedure could reliably produce both readouts. The qualified method was then formally transferred from the client’s laboratory to Avance’s Houston facility using a comparability approach: the same drug-product samples were tested independently by two operators at Avance and compared against results generated by the originating laboratory.
Assay Feasibility and Transfer
Each stage answered a question before the assay could be relied on at a new site:
- Biological response: Does the model respond the way the intended differentiation process should? Across feasibility and transfer runs, both the gene expression marker and the matrix biosynthesis marker showed clear, reproducible increases over untreated controls, consistent with the expected biological response and well past the predefined thresholds for a positive result.
- Operator precision: Do two operators at the new site agree with each other? Results from the two Avance operators testing the same samples were closely aligned for both assay endpoints, meeting the predefined precision acceptance criteria.
- Site-to-site comparability: Does the new lab’s data match the originating lab’s? Results from the receiving laboratory were comparable to those from the originating laboratory for both assay endpoints, meeting the predefined comparability acceptance criteria.
Customer Outcome
- A feasibility-confirmed combined potency assay (gene expression plus matrix biosynthesis) for a cell therapy product, successfully transferred to a second testing site
- Documented biological response, two-operator precision, and inter-laboratory comparability for both assay endpoints, all meeting predefined acceptance criteria
- Signed final feasibility and assay transfer reports, with the method established and running at the new site
Client Impact
The client now has its combined potency assay running at a second, comparability-confirmed testing site, ready to support drug product release for clinical testing for its clinical trials.
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