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  Pharmaceutical Technology Europe E-Alert
 
27 January 2015
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Featured Content
Fill/Finish Capacity Use for Biologics
There are significant differences between small molecules and biologics fill/finish capacity. More...
 
Analyzing Protein Aggregation in Biopharmaceuticals
Understanding and preventing protein aggregation is crucial to ensuring product quality and patient safety. More...
 
Mitigating Risk for Single-Use Assemblies in Sterile Filling
Risks associated with single-use technologies, such as product loss and sterility assurance, are magnified in the filling operation because of its closeness to the product in its final form. A thorough evaluation of the assembly design process, manufacture, and use can assist in identifying and mitigating these risks. More...
 
Top Stories
EMA Recommends Suspension of 700 Drugs Tested at GVK Site
GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. More...
 
Ebola Treatments Ramp Up for Clinical Trials
Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials. More...
 
Industry News
EMA Sets Elemental Impurities Implementation Dates
New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines. More...
 
EMA Publishes Safety Monitoring Guide
The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards. More...
 
Investment into T-Cell Therapies Continues
Syncona and Kite Pharma announced separate investments into T-cell therapies to fight cancerous tumors. More...
 
CPhI Worldwide Announces New Advisory Board
CPhI, a UBM EMEA organization, launched a new advisory board for 2015. More...
 
Europe Collaborates on Generic Drugs
The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union. More...
 
Catalent and MGC Pharma Partner for Production of Cell Lines
Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines. More...
 
BASF Announces Plans to Expand PVP Facilities
BASF announced that it would invest $65 million to improve its PVP manufacturing facilities, as well as add production to its Shanghai facility. More...
 
Giovanni Caforio Named BMS CEO
Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman. More...
 
CDC Publishes Information on Reducing Worker Exposure to Hazardous Drugs
A draft NIOSH Current Intelligence Bulletin on recommendations for reducing worker exposure to reproductive risks of drugs is available for public comment. More...
 
The Quest Continues for Quality Metrics
FDA’s aim is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis. More...
 
Baxter BioPharma Solutions Joins PBOA
Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board. More...
 
Webcasts
Overcoming Challenges in the Development of Active Drug-Layered Formulations for Multiple Dosage Forms
On Demand
Sponsored by Patheon
 
Practical Implications of the Lifecycle Approach to API Process Validation
On Demand
Sponsored by Regis Technologies Inc.
 
More Webcasts
Product/Service Profile
Colder Products Company
Colder Products Company
 AseptiQuik® connectors from CPC provide easy and reliable sterile connections for single-use biopharmaceutical processing. Robust designs for 1/8” (3.2mm) to 1” (26.4mm) quickly transfer valuable media. Read more & Download our Q&A
Shimadzu
i-series - the new driver of i-volution in HPLC analysis
Shimadzu, one of the world leaders in analytical instrumentation, has introduced the i-series of integrated HPLC and UHPLC systems. The analyzers meet the needs of any analytical environment with high speed, outstanding performance, maintainability and economic efficiency. Read more

Event Profile
BIO-Europe Spring® 2015 — 9th International Partnering Conference
Where the global biotech industry comes to partner
March 9–11, 2015
Paris expo Porte de Versailles - Pavillon 5
BIO-Europe Spring® is the springtime counterpart to EBD Group’s flagship conference, BIO-Europe®, and continues the tradition of providing life science companies with high caliber partnering opportunities. Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative startups.
Read more
Pharmapack Europe 2015: innovation, networking & education in pharmaceutical packaging and drug delivery technologies
11 & 12 February 2015
Paris Expo, Porte de Versailles (Hall 5)
More than 370 leading suppliers in pharma packaging and drug delivery technologies have already announced their participation and will meet with international pharmaceutical companies’ buyers and R&D managers at the 14th edition of Pharmapack Europe, taking place on the 11th & 12th February 2015 in Paris. Read More

Reference Library

Pharmaceutical Technology Drug Delivery Guides
A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects.  Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery. ... Click here
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