Sample Reports
Unmatched depth of experience in cell and gene therapy testing
Cell and gene therapies (CGT) and advanced therapy medicinal products (ATMP) are complex and technically demanding to manufacture. Solvias helps you meet the challenge with expertise in every aspect of CGT/ATMP analytical testing in a cGMP-compliant environment.
Breadth of capabilities
Solvias has expertise and capabilities spanning the entire product lifecycle, with particular expertise in cell-based potency assays. Our scientists are skilled at custom, phase-specific method design, development, transfer, and validation and release testing using a wide variety of analytical platform methods.
Specialized expertise
Our CGT expertise is strengthened by our acquisition of Cergentis, a leading provider of genetic quality control solutions for CGT and cell line development with an extensive record of peer-reviewed publications and groundbreaking technology. Our extensive regulatory knowledge and risk assessment experience enables phase-appropriate testing strategies.
Advanced technologies
Solvias uses an extensive array of leading-edge technologies, including all major physico-chemical technologies like UPLC/UPLC, LC- and CE- Mass spectrometry, bio-spectroscopy, capillary electrophoresis and amino acid analytics. Our proprietary Targeted Locus Amplification (TLA) technology, developed by Cergentis, enables detailed characterization of gene integration sites and flanking regions following transfection or transduction of target cells in cell and gene therapies.
Efficiency through experience
Our decades of experience in CMC testing of all major drug classes enables us to develop and validate effective analytical methods efficiently. We deliver customized solutions rapidly, accelerating the delivery of data and increasing our ability to achieve “right first time” results.
Our TLA-based solutions have been featured in 100+ peer-reviewed scientific publications
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