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PharmTech Europe
22 October 2019

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TOP STORIES

Sanofi Opens New Digital Manufacturing Facility in Massachusetts

The new location is one of the world’s first digital facilities to use intensified, continuous biologics production technology.
/ read more /


UCB to Acquire Ra Pharmaceuticals for $2.1 Billion

The transaction is set to be completed at the end of the first quarter of 2020.
/ read more /


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Industry News

Enterprise Therapeutics Receives Millions from Foundation to Develop Cystic Fibrosis Treatment

Enterprise Therapeutics is the recipient of funding worth up to £5.7 million (US $7 million) from the Cystic Fibrosis Foundation.
/ read more /


Lonza, Genmab Extend Drug Development Partnership

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.
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Regulatory News

EMA Report Shows Continued Efforts by European Countries to Reduce Antibiotic Use in Animals

A recently published European Medicines Agency (EMA) report has demonstrated that there are continued efforts being made across Europe to reduce the amount of antibiotics used in animals.
/ read more /


FDA Approves AstraZeneca Asthma Drug in Auto-Injector Pen

AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).
/ read more /


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Bio/Pharma News

Novo Nordisk, bluebird bio Partner to Develop Genetic Disease Therapeutics

The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including haemophilia.
/ read more /


CombiGene and Cobra Biologics Sign Agreement for Epilepsy Gene Therapy Drug

The long-term agreement gives CombiGene the authority to manufacture and commercialize the drug if it is approved after clinical studies.
/ read more /


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Supplier News

GammaDelta Therapeutics Announces Spin-Out Company Formation

GammaDelta Therapeutics has unveiled the formation of a new spin-out company, Adaptate Biotherapeutics, aimed at developing antibody-based therapies that modulate gamma delta T-cells.
/ read more /


Nonacus Launches Clinically Enhanced Exome Capture Kit

Nonacus has revealed the launch of its new capture kit, ExomeCG, which has been designed to simplify molecular and cytogenomics data generation and interpretation.
/ read more /


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FEATURED TOPICS

PEER-REVIEW

Optimizing Manufacturing Based on the Storage Stability of Pegylated Products

Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.
/ read more /

 

MANUFACTURING

Best Practices in Handling HPAPIs

Establishing OEL data and ensuring appropriate engineering controls are crucial aspects of safe handling.
/ read more /

ANALYTICS

The Fundamentals of Dissolution Testing

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.
/ read more /

API SYNTHESIS AND MANUFACTURING

Stability Testing for Small-Molecule Clinical Trial Materials

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.
/ read more /


PRODUCT PROFILE

Shimadzu

LCMS-8060 triple quadrupole mass spectrometer
Shimadzu’s LCMS-8060 is designed to push the limits of LC/MS/MS quantitation for applications requiring the highest sensitivity and robustness while delivering a meaningful solution for routine LC/MS/MS analyses.
/ read more /


EXHIBITOR PROFILE

DWK Life Sciences

Hall 11.1 Booth 111H20

DWK Life Sciences, represented by SciLabware (a wholly owned company of DWK Life Sciences), manufacture and supply a complete portfolio of standard and bespoke primary packaging solutions and services that meet and exceed the rigorous requirements and expectations of our customers.
/ read more /

EVENT PROFILE

Validation University

Date: 25 – 27 November 2019
Venue: Rochestown Park Hotel, Cork, Ireland

Validation University is a dream come true for engineering, quality, C&Q and validation professionals by offering hands-on training for the pharmaceutical, biotech, medical device and related industries. Participants create their own experience by choosing from over 50 tutorials and benefit from the wealth of knowledge and useful material our faculty exchanges.
/ read more /

ON DEMAND WEBCAST

How Can You Transform the Patient Experience through Digital Transformation?
On Demand
Learn more


Events

The Universe of Pre-filled Syringes and Injection Devices

Gothenburg, Sweden

22–23 October 2019

CPhI Worldwide

Frankfurt, Germany

5–7 November 2019

Outsourcing & Supply Chain–A 360° View

Lisbon, Portugal

12–13 November 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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