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    biologics manufacturing

    Mixer Bag-Innovative Bio-Pharmaceutical Mixing Bag

    Introducing Ami Polymer mixer bags are specifically designed to meet the rigorous demands of the bio-pharmaceutical and single-use disposable industries. Engineered for superior performance, these bags are offered in a variety of internal dimensions, ensuring optimal compatibility with your unique process requirements. Manufactured in a controlled environment, our mixer bags are produced in an ISO …

    Sampling Manifolds in Single-Use Systems for Bioprocessing

    In the case of biopharmaceuticals, industry standards demand that during every step of the vaccine or biologics manufacture processes, sterility and integrity of these bioprocesses is sustained. critical part of this is the ability to collect process fluids at predetermined time intervals for analysis without introducing any contamination. This is where a Sampling Manifold in …

    Single-Use Technologies in Biologics Manufacturing: Benefits, Challenges, and Growing Demand

    The increasing adoption of single-use technologies (SUT) in the biopharmaceutical industry is largely due to the added flexibility and cost reduction along with shortened marginal development times provided by SUT innovations. Unlike stainless steel systems SUTs virtually devoid of capital investments and also eliminate labor intensive cleaning and sterilization, while also containing the risk of …

    Aragen to Manufacture Renaissance Pharma’s Fast-Track mAb

    Aragen, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), has successfully tech-transferred and manufactured the first commercial-scale GMP batches of Renaissance Pharma’s lead candidate, Daretabart – a humanized monoclonal antibody targeting GD2 for high-risk neuroblastoma – in just 9 months. The anti-GD2 monoclonal antibody received Fast Track Designation from the FDA in April 2026 for …

    How Single-Use Sterile Connectors Are Tested for Quality and Sterility

    Sterile-to-sterile (S2S) single-use connectors have become foundational technologies in modern biopharmaceutical manufacturing. As biologics, cell therapies, mRNA platforms, and highly potent drug products continue to drive flexible manufacturing strategies. The industry has increasingly shifted away from fixed stainless-steel transfer systems toward disposable closed fluid management technologies. In this transition, sterile connectors are no longer viewed …