PharmTech Europe, Weekly Alert
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PharmTech Europe
20 February 2018

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Top Stories

Charles River Acquires MPI Research

A $800-million acquisition of MPI Research expands Charles River’s offerings for early-stage contract research.
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Applying GMPs in Stages of Development

Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety.
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Industry News

BIO Publishes Report on Pain Meds

A new report states that more research and clinical development must be done in the treatment of pain and addiction.
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FDA Releases Guidance on Systemic Antibacterial Drugs

The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.
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Regulatory News

GSK’s Influenza Vaccine Gets EU Nod for Expanded Indication

Fluarix Tetra has been approved for use in children aged six months old and above.
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Poor Aseptic Practices Found at Korean Facility

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.
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Bio/Pharma News

J&J and Theravance in $1-Billion Deal for Inflammatory Bowel Disease

Through its Janssen pharmaceutical companies, Johnson & Johnson, has partnered with Theravance to develop and commercialize a therapeutic for inflammatory bowel diseases.
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Fujifilm, Takeda Partner on Regenerative Medicine Therapies

The companies will work together on developing regenerative medicine therapies for heart failure.
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More Bio/Pharma News

Supplier News

ADC Bio to Develop New Bioconjugation Process

The new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.
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Cobra Biologics, Symbiosis Awarded Innovate UK Grant

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.
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More Supplier News

FEATURED TOPICS

Generic Drugs/Biosimilars

Opportunities and Obstacles for Generic Drugs

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
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Facilities

Designing a Single-Use Biopharmaceutical Process

Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.
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Manufacturing

Case Study: Fast-Track Technology Transfer of a Soft-Gelatin Capsule

Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer.
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Analytics

The Power of Synchrotron X-Ray Powder Diffraction for the Characterization of Pharmaceuticals

X-ray powder diffraction exploits the interaction between x-rays and matter to study the structural and microstructural properties of materials.
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LIVE WEBCASTS

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

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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