ProtaGene
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Manufacturing
ProtaGene and Merck partner to deliver end-to-end biologics testing
The duo will combine ProtaGene's early-stage biologics expertise with Merck's BioReliance GMP testing infrastructure, offering biopharmaceutical customers an integrated testing solution across the full drug development lifecycle
Finance
New capital strengthens ProtaGene's advanced analytical leadership in the biologics and CGT markets
ProtaGene GmbH, a leading global contract research organization (CRO) dedicated to advanced analytics for biologics and cell and gene therapies, announces additional investment from Ampersand Capital Partners
Regulatory
Confronting molecular bioanalysis challenges in gene therapy development
As the gene therapy sector continues to mature, regulators’ expectations for more robust product understanding are growing. It’s exciting to be part of today’s gene therapy development community; however, three issues are at the top of the industry’s mind—the regulatory landscape, critical molecular bioanalysis considerations (biodistribution, transgene expression, and vector shedding), and assay-related challenges