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BioPharm International
September 11, 2018
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Top Stories

Biosimilars Battles Heat Up

FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
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Novartis to Sell Parts of Sandoz in $1-Billion Deal

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

Study Finds Candidate for Universal Flu Vaccine Protects Against Multiple Strains

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 UNCW Awarded $1.12M Biomanufacturing Workforce Development Grant

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

Biopharma News

Emergent to Acquire Opioid-Focused Adapt Pharma in Deal Worth $735 Million

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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Sanofi Partners with Dyadic to Research Fungus-Based Expression Platform

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

Sartorius Stedim Biotech and Repligen Corporation Partner to Introduce Perfusion-Enabled Bioreactors

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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AGC Biologics Expands Capacity at Denmark Facility

The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.
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Regulatory News

FDA Expands NDMA Investigation to All ARB Class Drugs

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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Hospitals Back Generic Drug Production Venture

More than 120 healthcare organizations plan to bring competition to generic drug market.
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Process Development Forum

Need to optimize your manufacturing systems? Find insights, solutions, and shortcuts in bioprocessing at ProcessDevelopmentForum.com.
Click here to access the site »

FEATURE TOPICS

MANUFACTURING

Comparing the Supply Lifecycle of Bioreactors

Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.
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DRUG DEVELOPMENT

Process Validation in Biologics Development

The changing regulatory and manufacturing environment is ushering in a new approach to drug development.
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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.
Learn more

QUALITY SYSTEMS

Managing Quality in Single-Use 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

Choosing an Analytical Partner in Early Drug Development

Successful outsourcing relationships for early phase analytics in drug development are driven by partnership.
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PRODUCT AND SERVICE PROFILE

bioMérieux

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
Register now


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
Register now


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
Register now


The Multi-Attribute Method (MAM): Advancing Biopharmaceutical Discovery, Development, and Manufacturing
Wednesday, October 3, 2018 at 11am | 8am PDT | 4pm BST | 5pm CEST
Register now


Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Aggregates
Wednesday, September 19, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


Taking Charged Variant Analysis of Therapeutic Proteins to the Next Level
Friday, September 14, 2018 at 11am EDT | 8am PDT |4pm BST | 5pm CEST
Register now


ONDEMAND WEBCASTS

Rapid Low-level Identification and Quantitation of Host Cell Proteins
On Demand
Learn More


Characterizing Protein-Nucleic Acid Interactions by Light Scattering
On Demand
Learn More


Events

SMi's 9th Annual Biosimilars & Biobetters Conference

September 26–27, 2018

CPhI 2018

October 9–11, 2018

bioLIVE

October 9–11, 2018

more events

eBook

Single-Use Systems 2018 eBook

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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