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PharmTech Europe

13 September 2016

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Top Stories

HHS Awards $8.2 Million to Moderna for Zika Vaccine Development

The department gave Moderna $8.2 million to accelerate development of an mRNA-based Zika vaccine.
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EDQM Publishes Elemental Impurities Guideline

The agency published a guideline for the implementation of ICH Q3D.
/ read more /


A Global Fight Against Antimicrobial Resistance

Regulatory agencies meet to discuss approaches to the development of antibacterial agents.
/ read more /


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EXPERT INTERVIEW

Barry Holtz, president, iBio CMO sat down with Pharmaceutical Technology to discuss plant models in biopharmaceutical manufacturing.

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Industry News

Pan Drugs Limited Receives FDA Warning Letter

The Indian facility was cited for a range of quality and data integrity violations.
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Chinese Facility Receives Warning Letter

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
/ read more /


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Regulatory News

Microbial Contamination Leads to Recall of Eye-Wash Solutions

A customer complaint revealed microbial contamination issues affecting lots with expiration dates in late 2018 and early 2019.
/ read more /


Quality Issues Found at Brazil Drug Manufacturing Facility

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.
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More Regulatory News
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Getting the Full Picture Predicting Protein Stability Using Chemical and Thermal Denaturation
Live Webinar: Thursday, September 28 at 11:00 am EDT
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Bio/Pharma News

Allergan Acquires RetroSense Therapeutics

Allergan acquired clinical-stage gene-therapy company, RetroSense Therapeutics, for $60 million.
/ read more /


Syngene International Establishes R&D Center for Amgen

The company established a dedicated research center in Bangalore, India for Amgen.
/ read more /


More Bio/Pharma News

Supplier News

Aptar Pharma Forms Pact with BD to Develop Novel Autoinjector

Aptar Pharma has signed a license agreement with BD to jointly develop and bring a new autoinjector to market.
/ read more /


Cambrex Invests in Expansion at Swedish Facility

The company invested SEK 72 million ($9 million) to expand manufacturing capacity at its Karlskoga facility in Sweden.
/ read more /


More Supplier News

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Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
Live Webinar: Tuesday October 11 at 11:00 am EDT
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FEATURED TOPICS

DRUG DEVELOPMENT

The BioRegion of Catalonia—A Unique Life-Sciences Hub in Europe

Barcelona is set to host two well-known pharmaceutical events in the upcoming calendar year: CPhI (October 4–6, 2016) and BIO Europe Spring (March 20–22, 2017). The city is the heart of the BioRegion of Catalonia, believed to be the most dynamic bioregion in Spain and one of the most active in Europe.
/ read more /

 

PROCESS DEVELOPMENT

Next Steps for Investment in Continuous Manufacturing Research

A US government report on advanced manufacturing promotes continuous manufacturing of pharmaceuticals, which has had recent commercial success but faces challenges for widespread adoption.
/ read more /

MANUFACTURING

Manufacturing and Distribution Boundaries Blur

Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.
/ read more /

ANALYTICS

Evaluating Practical Uses of Molecular Isotopic Engineering

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.
/ read more /


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Don't Let the Diluent be Your Weakest Link in Your Drug Product
Live Webinar: Thursday, October 13 at 10:00 am EDT
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Product/Services Profiles

ABITEC Corporation

INJECTA
ABITEC Corporation is dedicated to the advancement of essential bioavailability enhancement and formulation development technology. ABITEC synthesizes and produces lipid based excipients to enhance bioavailability of poorly water soluble and poorly permeable molecules for the pharmaceutical industry.
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EtQ

EtQ Reliance Solution for Life Sciences
EtQ is the leading Quality, Compliance and EHS Management software provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration.
/ Read more /


Event Profile

CPhI Worldwide, ICSE, InnoPack, P-MEC, FDF

Date: Exhibition: 4th-6th October, 2016 Pre-Connect Congress : 3rd October 2016
Venue: Fira de Barcelona Gran Via, Barcelona, Spain
CPhI Worldwide, the world's leading pharmaceutical platform, co-located together with ICSE, InnoPack, P-MEC and FDF, brings together year on year over 36,000 industry experts from 153 countries around the world to meet and greet, do business and shape the future of the global pharmaceutical industry.
/ Read more /


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 Library

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo

A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
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More Reference BookS

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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