At Elevalue Laboratory, we’re committed to accelerating the development of groundbreaking therapies in the rapidly advancing fields of Cell and Gene Therapy (CGT) and Biologics.
We understand the challenges for the potency/bioassay development for Biologics and Cell&Gene Therapies and offer industry top-notch expertise
We offers end-to-end analytical support from assay development, qualification/validation, and testing for non-compendial methods
We are committed to deliver high quality services with speed to meet your timelines and goals.
Cell and Gene Therapy stands at the forefront of medical innovation, promising transformative treatments for previously incurable conditions. At Elevalue Laboratory, we empower your journey from concept to clinical studies and commercialization, specializing in complex bioassay development and comprehensive analytical solutions. Our expertise accelerates your path to IND and BLA submissions through assay development, phase-appropriate analytical method validation, and comprehensive testing services for CGT and Biologics. Partner with us to transform your groundbreaking science into life-changing medicines —our experienced team delivers swift, efficient analytical strategies that keep you ahead in this rapidly evolving field.
Our extensive service include:
-Analytical Development for Cell and Gene Therapy and Biologics
-Potency assay development for CGT and Biologics for Initial IND and beyond
-Fast, Customized, QC-ready Assay Development, Characterization Assay Development
-Assay Transfer
-IND-enabling analytical services
-Control Strategy with Spec Justification
-Custom Project
Elevalue Laboratory is dedicated to the complexities of CGT and Biologics, bringing specialized knowledge and advanced methods that meet the unique demands of this field. With our team’s in-depth understanding, we address the rigorous standards and challenges associated with these groundbreaking therapies.
Speed and precision are crucial in the biotech industry. We prioritize both by Enabling Accelerated Pathways to IND & BLA method validation that streamline the pathway to successful IND and BLA submissions. Our experience helps you navigate regulatory requirements with confidence and efficiency.
From concept through commercialization, our laboratory offers a seamless suite of services—including bioassay development, analytical testing, and data analysis. This all-inclusive approach means you have a single, reliable partner for your project’s entire analytical journey.
Speed and Quality both are crucial in this sector. Quality is central to Elevalue Laboratory’s core values.
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