Pharmaceutical Technology ePT Weekly
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PharmTech
November 15, 2019
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In this issue:

Rentschler Biopharma to Launch US Center of Excellence

FDA Enhances Postmarket Drug Safety
Surveillance Practices

GE Healthcare Life Sciences, Akeso
Pharmaceuticals to Accelerate Novel Therapy Manufacturing in China


Top Stories

Amgen Enters into Collaboration with BeiGene for $2.7 Billion

The transaction is expected to be finalized in early 2020.
/ read more /


Thermo Fisher Scientific to Invest $24 Million to Expand Global Bioproduction Capabilities

The company will invest $24 million into its Inchinnan, Scotland, site to expand global bioproduction capabilities with additional large-volume liquid manufacturing capacity for cell-culture media.
/ read more /

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Industry News

NIH Announces Vaccine Protected Monkeys Against Hemorrhagic Fever Viruses

Scientists from the University of Texas Medical Branch in Galveston and Profectus BioSciences of New York have developed the candidate quadrivalent VesiculoVax vaccine, an investigational vaccine that protected monkeys against four types of hemorrhagic fever viruses endemic to overlapping regions in Africa.
/ read more /


CPhI Announces 16th Annual CPhI Pharma Awards Winners

The winners were announced during day one of CPhI Worldwide.
/ read more /


More Industry News

Supplier News

GE Healthcare Life Sciences, Akeso
Pharmaceuticals to Accelerate Novel Therapy Manufacturing in China

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.
/ read more /


Stevanato Group, Duoject Medical Systems
Announce Partnership for New Auto-Injector

The companies plan to promote and manufacture Maverick, an emergency-use, cartridge-based auto-injector.
/ read more /


More Supplier News
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Bio/Pharma News

Rentschler Biopharma to Launch US Center of Excellence

The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility.
/ read more /


Samsung Announces Manufacturing
Agreement with Ichnos Sciences

Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale.
/ read more /

More Bio/Pharma News

Regulatory News

FDA Enhances Postmarket Drug Safety
Surveillance Practices

In a statement, Janet Woodcock MD, director of FDA’s Center for Drug Evaluation and Research, highlighted the agency’s efforts to enhance the efficiency of postmarket drug safety surveillance.
/ read more /


Trump Nominates New FDA Commissioner

Oncologist Stephen Hahn has been nominated for the top post, following the appointment of Brett Giroir as acting commissioner.
/ read more /


More Regulatory News

FEATURED TOPICS

FORMULATION

Avoiding Bitter Taste

Palatability is crucial for adherence and compliance to oral drug regimens.
/ read more /


PEER-REVIEWED RESEARCH

Optimizing Compression Coating for Pulsatile Release Tablets

Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.
/ read more /

MANUFACTURING

The Emergence of Operational Technology as a Service

The pressure to improve operational technology performance combined with the rapid pace of technology change is driving adoption of new automation models in pharmaceutical manufacturing.
/ read more /


ANALYTICS

Residual Moisture Determination in Lyophilized Drug Products

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.
/ read more /


ON DEMAND WEBCASTS


From Basics to Best Practices: Exploring Bioassays and Binding Assays
On Demand
Learn More


Replacing Settle Plates with Active Air Sampling
On Demand
Learn More


How to Approach Preparative LC for Compound Purification in the Research and Development Laboratory
On Demand
Learn More


Choosing The Right CDMO For Late-Phase Clinical Trials
On Demand
Learn More


New Research Revealed on a Promising Functional Alternative to Surfactants within Biologic Formulations
On Demand
Learn More


Data Integrity and the Next Level of Connectivity in a Modern Lab
On Demand
Learn More


The Product Development Superhighway: Leveraging End-to-End Solutions for Market Success
On Demand
Learn More


An Integrated Approach to Rapidly Delivering Bioavailability-Challenged Small Molecules to the Clinic
On Demand
Learn More


New Draft USP <922> Chapter for Water Activity Measurement
On Demand
Learn More


Workflow Breakthroughs that Are Improving Data Quality and Efficiency and Changing Pharmaceutical Analysis
On Demand
Learn More


Events

Validation University

November 25–26, 2019

Twin Screw Workshop

December 4–5, 2019

Computer Systems Validation & Data Integrity Compliance Congress

December 9–11, 2019


more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2019

The editors explore novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.


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