By Dr. Daniel Waldera-Lupa and Dr. Heiner Falkenberg Host cell proteins (HCPs) have long been recognized as critical process-related impurities in the development and manufacturing of biopharmaceuticals. Regulatory expectations clearly emphasize the need to monitor and control residual HCPs throughout development, yet the way these impurities are assessed is rapidly evolving. For many years, HCP […]
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ProtaGene today announced a strategic partnership with the Life Science business of Merck, which operates as MilliporeSigma in the United States and Canada, to provide biopharmaceutical customers with an end-to-end testing solution across the entire biopharmaceutical product lifecycle, from early-stage development through GMP release testing. ProtaGene’s expertise in advanced protein characterization and early-stage drug product […]
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The development of modern biologics has significantly expanded the therapeutic possibilities of monoclonal antibodies and related modalities. However, with increasing complexity, the requirements for their functional characterization have evolved as well. Beyond target binding, a central question has come into focus: Are biologics functionally performing as intended within the immune system? “Effector function in monoclonal […]
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ProtaGene, a leading global contract research organization (CRO) dedicated to advanced analytics for biologics and cell and gene therapies, today announced additional investment from Ampersand Capital Partners. Given the critical importance of advanced bioanalytics and product characterization for developing increasingly complex therapeutics, Ampersand has invested nearly $40 million within the past year to support ProtaGene’s […]
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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. #1 […]
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In April 2021, the FDA approved the 100th monoclonal antibody as a therapeutic entity, a milestone that took 35 years to reach. As of the fall of 2022, the FDA has approved 162 antibody therapies, and approval momentum continues to accelerate. Classical IgG-based monoclonal antibodies (mAbs) are by far the most mature protein-based therapeutic modality, […]
continue readingProtaGene GmbH, a leading global contract research organization focused on advanced analytics in biologics and cell and gene therapy, announced today the appointment of Jennifer Chadwick, Ph.D., as Chief Scientific Officer and Owen Hitchins as Chief Commercial Officer. Working in close collaboration, accomplished executive leaders Chadwick and Hitchins will utilize their respective experience to meet […]
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ProtaGene is thrilled to announce the planned opening of our brand-new, state-of-the-art lab and office headquarters in the Burlington BioCenter, located in Boston’s rapidly growing biotechnology hub. Our expanded footprint is designed to enable new capabilities required to advance today’s biologic and gene therapy platforms and provide additional capacity to meet the growing demand for […]
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