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Immobilized rProtein Solutions SDS - Chinese
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Repligen Launches TangenX® SC as First-to-Market Holder-Free Self-Contained TFF Device
- Targeting ADC and Cell & Gene Therapy Customers - WALTHAM, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) - Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced the commercial launch of TangenX® SC, the industry’s first holder-free, self-contained Tangential Flow Filtration (TFF) device. The technology is especially suited to the manufacture of biologics where fully closed systems are critical or ideal, including antibody drug conjugates (ADCs), viral vectors, nucleic acids and lipid nanoparticles, and can also be applied to monoclonal antibody, and recombinant protein production. TangenX SC is not only transformative, it is also a milestone achievement in the advancement of downstream flat sheet TFF technology for ultrafiltration and diafiltration (UF/DF), which is performed in nearly every biopharmaceutical manufacturing process to concentrate and purify drug. Christine Gebski, Senior Vice President, Filtration and
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Repligen Receives Complete Response Letter from FDA for RG1068 NDA
Repligen Corporation (NASDAQ:RGEN) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for RG1068 (synthetic human secretin). RG1068 was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with known or suspected pancreatitis. The CRL indicates that the FDA has completed its review of the RG1068 NDA and has determined that additional clinical efficacy and safety trial data will be required to support potential approval of the NDA. There were no specific safety concerns cited in the CRL, although safety will continue to be monitored in conjunction with any future clinical trial. No deficiencies were cited in the CRL with respect to the manufacturing, pharmacology or toxicology sections of the NDA. “We will continue to engage in dialogue with the FDA to determine the design and scope of a
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Immobilized rProtein Solutions SDS - English (EU, UK)
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Manual TFF lab scale chaos to controlled success
Not all TFF systems are created equal. Turn the chaos of manually adjusting flowrates, monitoring pressures and documenting data every 10 minutes into automated TMP control and data recording. During this webinar we’ll discuss how the KrosFlo® KR2i, KMPi, and FS family of systems solve challenges of human error, reproducibility, and scalability with economical, easy-to-use lab scale TFF systems with automation capabilities.