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Top Stories
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
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Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.
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Industry News
Research from the Perelman School of Medicine at the University of Pennsylvania suggests that a universal flu vaccine that protects people against most influenza strains is one step closer to reality.
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Alcami and the University of North Carolina Wilmington received a grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals to prepare students for careers in pharmaceutical sciences.
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Ca⁺⁺Pure-HA®, a hydroxyapatite media from Tosoh Bioscience, provides unique multimodal separation properties and unequalled selectivity and resolution for multiple classes of biomolecules. With a DBC of 55 mg mAb/mg resin at 5 min residence time, this resin also demonstrates an increased mechanical and pH stability. Learn more
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Biopharma News
Emergent BioSolutions is set to acquire Adapt Pharma, a pharmaceutical company focused on addressing the opioid overdose and addiction crisis, in a deal worth up to $735 million.
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The collaboration will explore the potential of Dyadic's gene-expression platform to produce multiple biologic vaccines and drugs.
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Supplier News
A collaboration integrates Sartorius Stedim Biotech's BIOSTAT STR bioreactors and Repligen's XCell ATF cell-retention control technology to create simplified, scalable equipment for intensified cell culture.
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The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.
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Did you know you can streamline your workflows with a faster, more in-depth view of your biologic with Multiple Attribute Methodology (MAM) using Accurate Mass LC-MS? Discover the complete BioPharmaView™ Software 3.0 workflow for MAM and learn how to accelerate your biotherapeutic development. Get up to speed by accessing the information packed SCIEX MAM Knowledge Accelerator at: https://ter.li/k0q5lh
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Regulatory News
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
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FEATURE TOPICS |
MANUFACTURING
Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.
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24th Annual Validation Week
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.
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QUALITY SYSTEMS
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
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OUTSOURCING
Successful outsourcing relationships for early phase analytics in drug development are driven by partnership.
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PRODUCT AND SERVICE PROFILE
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EVISIGHT® COMPACT works with ordinary ready-to-use plates and filters, allowing easy implementation and validation for the daily routine.
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UPCOMING WEBCASTS
Using High-Throughput Automation to Accelerate Biologic Drug Formulation
Thursday October 25, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Protein A Chromatography: Important Features in Purification to Reduce mAb Aggregation and Increase Recovery
Tuesday, October 23, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Screen Hundreds of N-Glycans per Day: More Samples – Better Decisions – Faster
Europe Broadcast: Thursday, October 4, 2018 at 2pm BST | 3pm CEST
US Broadcast: Thursday, October 4, 2018 at 11am EDT | 10am CDT | 8am PDT
Asia Pacific Broadcast: Friday, October 5, 2018 at 11am CST | 12pm JST | 1pm AEST
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The Multi-Attribute Method (MAM): Advancing Biopharmaceutical Discovery, Development, and Manufacturing
Wednesday, October 3, 2018 at 11am | 8am PDT | 4pm BST | 5pm CEST
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Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Aggregates
Wednesday, September 19, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Taking Charged Variant Analysis of Therapeutic Proteins to the Next Level
Friday, September 14, 2018 at 11am EDT | 8am PDT |4pm BST | 5pm CEST
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Events
September 26–27, 2018
October 9–11, 2018
October 9–11, 2018
more events
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eBook
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A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs.
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