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Top Stories
After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.
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The acquisition will enhance Lundbeck's brain disease therapy portfolio as well as its antibody process and development capabilities.
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Industry News
The project focused on accelerating the discovery and development of monoclonal antibodies and aimed to tackle the limitations in the biologics supply chain.
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The new board will assume their positions at the 2019 ISPE Annual Meeting & Expo on Oct. 27–30, 2019 in Las Vegas, NV.
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Ensure the safety and efficacy of gene therapy products.
Attend Eurofins BioPharma Product Testing’s webinar on November 7th discussing the Testing of Bioprocess Residual Impurities in Gene Therapy Products. During this webinar you will learn about the typical residuals associated with the production of gene therapies, analytical approaches, challenges with platform methodologies, and how to deal with matrix effects.
Register Now » 
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Biopharma News
The companies have advanced their collaboration to the next stage and will continue to develop a plant-based biosimilar candidate to Roche's Rituxan.
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Under a new co-development license agreement, Boehringer Ingelheim and Inflammasome Therapeutics aim to develop novel therapies for retinal diseases.
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Supplier News
The new site will provide employees with more space, enhanced R&D facilities, and a fully functional sanitary products training center.
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The companies will focus on identifying peptides applicable to the affinity chromatography process used in the purification of biopharmaceuticals.
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Biopharma N-Glycan Analysis Resource Center
An online resource with useful tools and practical information to find out more about Biopharma N-Glycan Analysis. The site provides useful webcasts, videos, application notes, posters, and more from leading practitioners in the field of chromatography.
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Regulatory News
FDA has approved Novo Nordisk's Rybelsus (semaglutide), a glucagon-like peptide receptor protein treatment in oral tablet form for type 2 diabetes.
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In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.
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FEATURED TOPICS |
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MANUFACTURING
Innovation in manufacturing technologies must occur to ensure the availability of gene and cell therapies.
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REGULATORY
As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.
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DOWNSTREAM PROCESSING
The latest advances in process chromatography include pre-packed chromatography columns, process characterization kits, fast protein liquid chromatography systems, and mixed-mode chromatography resins.
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UPCOMING WEBCASTS
Innovative and Effective Workflow Solutions for Oligonucleotides from Purification to Analysis
Tuesday, October 22, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Rapid Low-level Identification and Quantitation of Host Cell Proteins
Europe: Thursday, October 10, 2019 at 2pm BST | 3pm CEST
North America: Thursday, October 10, 2019 2pm EDT | 1pm CDT | 11am PDT
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USP General Chapter <1049.1> Design of Stability Studies for Biotechnology Product Development and Lifecycle Management
Wednesday, October 9, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Digging Deeper in Every Direction: Developing a Next-Generation Platform for High-Throughput Multi-Faceted Protein Characterization
Thursday, October 3, 2019 at 11am EDT | 8am EDT | 4pm BST | 5pm CEST
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Events
October 16, 2019
October 27–November 1, 2019
November 3–6, 2019
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eBook
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The editors examine the technology, practices, and regulatory approval questions facing
companies employing single-use technologies for commercial manufacturing.
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