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PharmTech Europe

26 July 2016

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Top Stories

Open-Access Technology Seeks to Make Drug Discovery Easier

A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.
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Pfizer Receives Prequalification for Presentation of Prevenar 13

The company received prequalification for its Prevenar 13 MDV, which allows global use of the vaccine by United Nations countries and agencies.
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EXPERT INTERVIEW

Francis Flanagan, associate principal scientist at Merck, sat down with Pharmaceutical Technology to discuss using minitablets in pharmaceutical manufacturing.

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Industry News

SmithKline Beecham Gets Warned for Contamination

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.
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EMA Suspends Drugs Due to Flawed Bioequivalence Studies

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.
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Regulatory News

EMA Accepts Pegfilgastim Biosimilar for Review

The agency will review Mylan and Biocon's biosimilar to pegfilgrastim.
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EMA Recommends Approval of First HIV Pre-Exposure Prophylaxis Drug in the EU

The agency has recommended granting marketing authorization in the EU for Truvada.
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Bio/Pharma News

Ionis Pharmaceuticals Licenses Oral RNA-based Therapeutic to Janssen

The antisense drug will be the first in the companies' joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.
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Celgene Partners with Jounce Therapeutics for Immunotherapy Development

The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immuno-oncology.
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Bio/Pharma in China
New Initiatives, New Opportunities

On Demand
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Supplier News

MilliporeSigma to Relaunch Customer Collaboration Centers

The company announced that it will be relaunching its customer collaboration centers.
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SGS Invests in Genotypic DNA Sequencing System

The company invested in the MicroSeq Rapid Microbial Identification System from Applied Biosystems at its Illinois facility.
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FEATURED TOPICS

QA/QC

Cleaning Bioreactors and Fermenters with CIP Systems

Early planning for the integration of clean-in-place systems for equipment cleaning is key.
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FORMULATION

Exploring the Use of Aseptic Spray Drying in the Manufacture of Biopharmaceutical Injectables

Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.
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ASEPTIC/STERILE

Raplixa case study: Enabling an innovative drug presentation through aseptic spray drying

FDA approved the Raplixa, the first spray-dried fibrin sealant, in May 2015 to help control bleeding in adults during surgery.
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API SYNTHESIS & MANUFACTURING

Expanding the Chiral Toolbox

Recent chiral advances demonstrate promise for API synthesis.
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Product Profile

Thermo Scientific

Revitalize your pesticide quantitation workflows
The Thermo Scientific™ Pesticide Explorer Collection is a comprehensive set of LC-MS solutions designed for laboratories performing routine quantitation, targeted and non-targeted screening of pesticide residues in food matrices.
/ Read more /

Nexera-i MT

UHPLC and HPLC analysis on a single system

Shimadzu has released the new Nexera-i MT UHPLC system, based on the very successful i-Series platform launched in 2014. The instrument offers enhanced functionality to support transfer of existing HPLC to faster UHPLC methods while assuring high cross-compatibility between the old and new method conditions.
/ Read more /

Webcasts

Calibration and Qualification of Laboratory Instruments in Accordance with GMP Requirements

On Demand

Calibration, qualification, and the right appropriate level of routine testing for laboratory instruments are critical to ensuring high-quality results and maintaining GMP and USP compliance. Understand the relationship between these factors to optimize testing and be prepared for audit.
Sponsored by Mettler Toledo


Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs

On Demand
Poorly-soluble APIs present formulation and development challenges. Excipient selection and manufacturing process development are crucial. Continuous twin-screw granulation is gaining acceptance as a manufacturing technology to address issues presented by these APIs and offers high production capacity in a small footprint. Learn how to improve the solubility of poorly water-soluble active ingredient using twin-screw wet granulation and proper excipients.
Sponsored by BASF


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Events

14th Annual Pharmaceutical IT Congress

28-29 September, 2016 | London, England

CPhI Worldwide

4-6 October, 2016 | Barcelona, Spain

PDA Visual Inspection Forum

25-26 October, 2016 | Berlin, Germany


more events
 

Reference Book

Pharmaceutical Technology Outsourcing Guide

Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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More Reference Book

eBOOKS

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.

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