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BioPharm International
June 11, 2019
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Top Stories


Former Novartis Pharma Business Head Takes on CEO Mantle at Sanofi

Paul Hudson, formerly CEO of Novartis Pharmaceuticals, has been tapped to succeed Olivier Brandicourt as CEO of Sanofi.
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Biogen Completes $800-Million Acquisition of Nightstar Therapeutics

The acquisition will boost Biogen's gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.
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Industry News


New UK Life Sciences Asset Launches at BIO

A new United Kingdom life-science asset, HIRANI, was launched at a reception at BIO 2019.
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Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA

Jefferson established the Jefferson Institute for Bioprocessing workforce training institute in collaboration with NIBRT using the GE Healthcare FlexFactory Platform to produce biopharmaceuticals.
/ read more /


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Biopharma News


ERS Genomics, Bioneer Sign License Agreement for CRISPR Gene Editing Tech

ERS Genomics and Bioneer have revealed the signing of a license agreement for access to CRISPR/Cas9 genome editing technology intellectual property.
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Novartis Announces New Head of Pharmaceuticals Business Unit

The current president of Novartis' Advanced Accelerator Applications has been appointed as the new Novartis Pharmaceuticals president.
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Process Development Forum
Need to optimize your manufacturing systems? Find insights, solutions, and shortcuts in bioprocessing at ProcessDevelopmentForum.com.
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Supplier News


iBio Launches Sterile Fill/Finish Services

CDMO iBio introduced cGMP sterile fill/finish services at its facility in Texas.
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FUJIFILM Invests in New Continuous Processing Facility

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.
/ read more /


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Regulatory News


Consultation Opens on EMA's Draft Guidelines on Drug-Device Combination Products

EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.
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Federal Court Decides US Stem Cell Clinics Adulterated and Misbranded Products

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient's adipose tissue.
/ read more /


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FEATURED TOPICS

BIOPHARMACEUTICAL ANALYSIS

From Data to Information

Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.
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DRUG DEVELOPMENT

Taking Therapeutic Antibodies to the Next Level

This article explores the challenges and potential of next-generation therapeutic antibodies.
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MANUFACTURING

Moving PAT from Concept to Reality

The learning curve for process analytical technology has slowed widespread adoption.
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UPSTREAM PROCESSING

Streamlining Upstream Processing: A Good Place to Start

As cost and time pressures are on the rise, innovative expression systems may offer companies a good opportunity to streamline processes early on.
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UPCOMING WEBCAST

Improving Confidence and Productivity in Released Glycan Analysis for Biotherapeutic Development
Wednesday, July 17, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Empowering HCP Identification with Antibody Affinity Extraction (AAE) and Mass Spectrometry
Tuesday, June 18, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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ON DEMAND WEBCAST

Transforming High Performance LC-MS Analysis in Biopharma: From Molecular Characterization to Attribute Monitoring
On Demand
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Events

ISPE Biopharmaceutical Manufacturing Conference

June 18–20, 2019

4th PDA Europe Annual Meeting

June 25–26, 2019

BioManufacturing Conference

September 3–4, 2019

more events

eBook

Outsourcing Resources 2019 eBook

Experts share insight and advice for conducting CMC due diligence with contract development organizations, using multiple attributes methods to monitor quality attributes, and strategies for using specialized services for biopharmaceutical development applications.

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