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New Affinity Resin for COVID-19 Vaccine Purification
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Repligen agrees to buy Spectrum for $359 milion
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Think outside the blocks
Intensification is worth it. Build an intensified upstream suite brick by brick with XCell ATF® systems. Make twice as much product in half the time as you watch VCD grow and shrink bioreactor sizes within the same facility footprint.
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Repligen Announces Asset Purchase Agreement With BioMarin for HDACi Portfolio
WALTHAM, Mass., Jan. 21, 2014 (GLOBE NEWSWIRE) - Repligen Corporation (Nasdaq:RGEN) announced today that it has entered into an asset purchase agreement with BioMarin Pharmaceutical Inc. ("BioMarin") to advance Repligen's histone deacetylase inhibitor (HDACi) portfolio. The HDACi portfolio includes multiple orally bioavailable small molecule compounds as well as enabling technologies. Under the terms of the agreement, Repligen will receive an upfront payment of $2 million from BioMarin and it has the potential to receive up to $160 million in future milestone payments for the development, regulatory approval and commercial sale of portfolio compounds included in the agreement. In addition, Repligen is eligible to receive royalties on sales of therapeutic products originating from the HDACi portfolio. Potential applications of the HDACi portfolio include Friedreich's ataxia and other neurological disorders. "The outlicensing of our HDAC portfolio, which includes the Friedreich's ataxia
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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 clinical
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Repligen Announces FDA Advisory Committee Date for SecreFlo™ NDA
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Repligen Receives Notice of Allowance for Recombinant Protein A Patent
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Evolution of upstream intensification: Optimizing perfusion processes with PAT
Process analytical technology (PAT) in bioprocessing has improved manufacturing control while reducing variability and costs in process development and manufacturing. Leveraging PAT with process intensification tools drives robust, efficient, and scalable platforms. In this webinar, Bristol Myers Squibb scientists describe application of PAT to upstream intensification towards developing a mAb N-1 platform process with accelerated timelines. The optimal cell-specific perfusion rate and inoculation density were determined within 2- 3 experiments. The PAT landscape in upstream intensification, the benefits of this approach, and the scale-up from benchtop to manufacturing will be discussed.
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Where and When to Apply Upstream Process Intensification Technologies
Biopharmaceutical process intensification may be applied to multiple points in the workflow to increase productivity by orders of magnitude for diverse modalities, including recombinant proteins, vaccines, cell therapies, plasmid DNA and cultured meat. This webinar describes application of XCell ATF® Technology to the seed train and the production (N) bioreactor in different modes to create time, cost and facility efficiencies. 15+ years of published application data, implementation in the largest number of commercial processes and proven scaling from 1 L to 5000 L differentiate XCell ATF® Technology from all other upstream intensification methods. Considerations for when and why to apply XCell ATF® Technology in order to meet specific productivity goals will be discussed.
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Repligen Launches AAV Affinity Resins for Gene Therapy Purification
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