Functional Potency Assays for Batch Release

Our expertise in Functional Potency Assays for Batch Release

CYTOO develops and implements functional potency assays to support batch release by demonstrating biological activity, ensuring consistency and achieving regulatory compliance, particularly for gene therapies and biologics.

Our approach

Using our MyoScreen platform, we establish robust, quantitative in vitro assays that go beyond biomarker detection to measure actual functional outcomes in skeletal muscle cells.

For gene therapies, we have developed and patented methods to quantify both transgene expression and the functional activity of the encoded protein, addressing a key regulatory requirement for potency testing.

Our assays are compatible with high-throughput formats and automated workflows and are designed to be readily transferable to GMP environments.

We tailor assay development to each partner’s unique therapy through a rigorous process of customization, qualification, and validation, closely aligned with the clinical development of the product.

Case study

Potency assay development in differentiated muscle cells

GMP-compatible potency assay based on quantitative colocalization of disease-relevant proteins in muscle cells.

A custom image analysis pipeline enables adaptation to partner-specific therapeutic mechanisms.

This assay is patented, has fulfilled FDA Validation requirements, and can be implemented at CYTOO or transferred to external GMP-compliant CROs through a dedicated tech transfer process.

How can we work together

Everything is tailored to your needs through a flexible R&D partnership model that fosters true collaboration and innovation. We offer adaptable project structures and FTE allocation to fit your goals.

In cases of joint development, outlicensing opportunities are also available for our MyoScreen™ technology, including assays and customised image analysis scripts.