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Author: Firma ProtaGene

Effector Function in Biologics: Why ADCC, CDC and Cell-Based Potency Assays Define True Therapeutic Performance

Posted on 26. March 2026 by Firma ProtaGene Posted in General Tagged assay, biologic, biosimilar, bispecifics, cell, cells, clinical, company, dose, lab, mask, new, protagene, webinar, with

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 […]

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New Capital Strengthens ProtaGene’s Advanced Analytical Leadership in the Biologics and Cell and Gene Therapy Markets

Posted on 22. November 202326. January 2026 by Firma ProtaGene Posted in General Tagged ampersand, analytics, biologics, biosimilars, cell, cmc, CRO, discovery, disease, gene, lab, patients, protagene, research, therapy

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 […]

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Confronting Molecular Bioanalysis Challenges in Gene Therapy Development

Posted on 19. October 202326. January 2026 by Firma ProtaGene Posted in General Tagged assay, cell, clinical, cmc, development, gene, genomics, pcr, regualtory, therapy

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 […]

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Navigating CMC Challenges in NBE and Therapeutic Antibody Development

Posted on 11. September 202326. January 2026 by Firma ProtaGene Posted in General Tagged antibody, biotech, bipharma, development, drug, mab, pharma, protagene, research, therapy

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 […]

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ProtaGene Appoints New Scientific and Commercial Leadership to Support Evolving Needs of Biologic and Cell & Gene Therapy Innovators

Posted on 1. February 202326. January 2026 by Firma ProtaGene Posted in General Tagged bioanalytix, cell, cmc, genewerk, indigo, labcorp, market, new, patients, protagen, protagene, research, therapy, thermo, with

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 […]

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Foundation for the Industry’s Next-stage Innovation and Growth

Posted on 6. July 202226. January 2026 by Firma ProtaGene Posted in General Tagged analysis, analytics, drug, gene, genewerk, lab, labs, new, project, protagene, protein, storage, therapy, vector, with

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 […]

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