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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 Mehr
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 Mehr
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 Mehr
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 Mehr
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 Mehr
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 Mehr
ProtaGene 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 Mehr
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 Mehr