Cell-based Assays

Mycenax delivers end-to-end cell-based assay method development services, from initial concept design to full regulatory compliance, to support robust drug quality assurance. Our development workflow encompasses all critical stages, including cell line selection, parameter screening using a Quality by Design (QbD) approach, method optimization, and validation in accordance with international regulatory guidelines such as ICH Q2. At Mycenax, our methods are developed to be both scientifically rigorous and fully aligned with regulatory expectations, ensuring that your cell-based assays are always inspection-ready.


Critical Step for End-to-End Cell-Based Assay Development

Mycenax delivers end-to-end Cell-Based Assay (CBA) solutions that combine scientific precision with regulatory readiness. With deep expertise in cellular systems and analytical development, we create robust, reproducible, and compliance-aligned CBA platforms that support programs from early research through late-stage submissions. Our integrated approach streamlines development, strengthens assay performance, and ensures complete data integrity. With submission-ready documentation and a commitment to quality, we empower partners to advance their products with confidence and efficiency.

"Share Your MOA, We’ll Deliver Your Custom Cell-Based Assay"

	Potency/ Biological Activity Assay		Specialized Assays Designed for Your Product
	◆ Proliferation, Anti-Proliferation Assays		◆ Hemagglutination Assay
	◆ Fc Functional Assays		◆ Internalization Assay
	◆ Cell Activation Assays		◆ NK Cytotoxicity Assay
	◆ Reporter Gene Assays		◆ Migration Assay
	◆ Binding Assays
	◆ Customized Assays

Mycenax delivers end-to-end cell-based assay method development services, from initial concept design to full regulatory compliance, to support robust drug quality assurance.

Our development workflow encompasses all critical stages, including cell line selection, parameter screening using a Quality by Design (QbD) approach, method optimization, and validation in accordance with international regulatory guidelines such as ICH Q2.

At Mycenax, our methods are developed to be both scientifically rigorous and fully aligned with regulatory expectations, ensuring that your cell-based assays are always inspection-ready.

Critical Step for End-to-End Cell-Based Assay Development

Mycenax delivers end-to-end Cell-Based Assay (CBA) solutions that combine scientific precision with regulatory readiness. With deep expertise in cellular systems and analytical development, we create robust, reproducible, and compliance-aligned CBA platforms that support programs from early research through late-stage submissions. Our integrated approach streamlines development, strengthens assay performance, and ensures complete data integrity. With submission-ready documentation and a commitment to quality, we empower partners to advance their products with confidence and efficiency.