Minaris Advanced Testing is a global leader in viral clearance testing. Our deep technical expertise, harmonized quality systems and newly upgraded facilities make us the ideal partner for ensuring viral safety in biologics, gene therapies and viral vaccines.
We design and execute viral clearance studies aligned with ICH Q5A(R2), WHO guidelines and FDA/EMA expectations, whether you’re advancing toward IND, IMPD or BLA.
We tailor viral clearance studies to your process, product class and development phase:
Virus spiking and clearance validation
Selection of appropriate model viruses
Quantification of log reduction values (LRVs)
Customizable based on product modality and regulatory goals
Our dedicated viral clearance testing space in our Philadelphia, PA, facility includes:
Our scientific team offers complete study management, from protocol design to submission-ready reporting:
Whether you need GMP release testing for a commercial therapy or exploratory analysis for an early-phase asset, we’re here to help. Access our full testing catalogue or submit a sample request today.
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Accurate, timely, and compliant testing is critical to advancing complex therapies. Minaris Advanced Testing delivers a comprehensive suite of GMP biosafety and characterization services designed to support every stage of your program, from early research through IND, clinical and commercial requirements. Our team provides the experience, responsiveness and support you need. Get in touch today.
