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PharmTech Europe
27 February 2018

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Top Stories

Jefferson and NIBRT Partner on New Biomanufacturing Training Center

The new training center, the Jefferson Institute for Bioprocessing, will prepare engineering students and industry professionals for the field of biologics manufacturing.
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Salmonella Outbreak Possibly Connected to Opioid Substitute

FDA and CDC are investigating a multi-state Salmonella outbreak that appears to be caused by kratom, a plant used as an opioid substitute.
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Industry News

Novo Nordisk Publishes New Study on Bioproduction of Chemicals

The study suggests that circumventing evolution in cell factories can enable the commercialization of new biobased chemicals to large-scale.
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Drug-Delivering Capsules Support Transplanted Insulin-Producing Cells

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.
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Regulatory News

FDA Issues Guidance on Bioresearch Monitoring Content for NDAs and BLAs

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.
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FDA Publishes Guidance on Classification of Co-Crystals

The agency provides information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.
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More Regulatory News
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Bio/Pharma News

Vertex Receives FDA Approval for Continuously Manufactured Drug Product

FDA approves Vertex’s cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.
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AbbVie, Voyager Partner for New Alzheimer’s Therapies

The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer’s and other neurodegenerative diseases.
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More Bio/Pharma News

Supplier News

ABEC Expands Single-Use Manufacturing Capability

The company has expanded its single-use manufacturing capabilities at its facility in Fermoy, Ireland.
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AMRI to Expand Container Closure Integrity Testing Services into EU

The company aims to add the additional analytical services in the European Union throughout 2018.
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More Supplier News

FEATURED TOPICS

Outsourcing

Outsourcing Analytical Services in Early Drug Development

Successful outsourcing relationships in early phase drug-development analytics are driven by partnership.
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Peer-Reviewed Research

Establishing Correlation Between Aerosol and Surface Microbial Populations

The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
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Manufacturing

Material Traceability in Continuous Pharmaceutical Tablet Manufacturing

A systematic framework and software are needed to implement material traceability.
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Quality

Anticounterfeiting: In Search of the Unhackable

While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.
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Product Profiles

Catalent

Early drug formulation and development
Catalent partners with innovators to accelerate programmes through the early phases of development, overcome a molecule's solubility and bioavailability challenges, and increase its likelihood of success in the clinic.
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Veltek Associates, Inc.

SMA MicroParticle ICSTM
VAI is pleased to announce the addition of the SMA MicroParticle ICS line of non-viable particle counters that utilize the latest innovation in particle counting technology, to our contamination control portfolio.
/ Read more/


LIVE WEBCASTS

Top Quality Trends for 2018: Pharma Quality Survey Report
Live Webcast: Wednesday, March 7 at 11:00am EST
Register now


Successfully Progressing Therapeutic Candidates from Discovery to Development Using Early Developability Assessment Tools
Live Webcast: Wednesday, March 14 at 11:00am EDT
Register now


Real-Time Process Control for Healthy, High-Purity Water Systems
Live Webcast: Thursday, March 15 at 11:00am EDT
Register now


ON DEMAND WEBCAST

Assessing Product Integrity Risk Profiles and Engineering On-Dose Authentication During Drug Development Process
On Demand
Learn more


Events

9th Global Drug Delivery & Formulation Summit

Berlin, Germany

12–14 March 2018

Making Pharmaceuticals Europe 2018

Brussels, Belgium

13–14 March 2018

Paperless Lab Academy 2018

Milano, Italy

20–21 March 2018


more events

eBOOKS

Vaccines Development and Manufacturing 2017

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.

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