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  Pharmaceutical Technology Europe E-Alert
 
17 June 2014
IN THIS ISSUE
News
Webcasts
Events
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Featured Topics
The Role of Powder Characterization in Continuous Manufacturing
Experimental work on wet granulation demonstrates the use of dynamic powder characterization to support continuous processing for tablet manufacturing. More...
 
Packaging Innovations Abound
New packaging concepts and equipment, including systems for vial handling, printing and labeling, and parenteral packaging, were revealed at INTERPHEX 2014. More...
 
Q&A with Paul Nelles, Vetter Development Service
Paul Nelles of Vetter Development Service discusses prefilled syringes. More...
 
Podcast: Biosimilar Development Landscape
Kate Keeping, senior director of biosimilars research at Decision Resources Group, discusses the most popular targets and active geographic regions for biosimilars development. View now on BioPharm TV. More...
 
Top Stories
Research Firm Predicts Negative Impact of Biosimilars
A new report from GlobalData states that biosimilars will overtake the market share after 2019. More...
 
FDA Releases Draft Guidance on ANDA Submissions
Draft guidance from FDA includes information essential for the completion of ANDA applications. More...
 
EMA Publishes New Guidance for Qualified Person's Declaration on GMP Compliance of API
EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain. More...
 
Industry News
Glenmark Pharmaceuticals Opens Monoclonal Antibody Manufacturing Facility
The new mAb manufacturing facility in Switzerland will supply material for clinical development. More...
 
Total Facility Solutions Opens Hygienic Fabrication Center
The fabrication facility will supply modular construction to the US life-science market. More...
 
Merck to Acquire Idenix
Merck acquires Idenix Pharmaceuticals for $3.85 billion. More...
 
Cellectis Enters Agreement With CELLforCURE
Cellectis enters an agreement with CELLforCURE for cGMP clinical manufacturing of allogeneic T-cells. More...
 
Xcelience Opens European Packaging and Distribution Facility
Xcelience opens a clinical packaging and distribution facility in Birmingham, UK. More...
 
USP Helps Expand Worldwide Access to Tuberculosis Drugs
USP and USAID give prequalification status to Capreomycin, an anti-tuberculosis injectable. More...
 
Webcasts
Using Engineered Particles in Capsules for Rapid-to-Clinic Dry Powder Inhalation Applications
Wednesday June 25, 2014 at 11:00 AM EDT
Sponsored by: Capsugel
 
Best Practices to Overcome Softgel Coating Challenges
Wednesday, July 9, 2014 at 11:00 AM EDT
Sponsored by: BASF
 
Optimizing Bioavailability: Enhancing Pharmaceutical Productivity
On Demand
Sponsored by: BASF and Catalent Pharma Solutions
 
Optimizing Microbial Quality Control Testing
On Demand
Sponsored by: Rapid Micro Biosystems
 
More Webcasts

Products/Services Profiles
Pfizer CentreSource
Pfizer CentreSource (PCS) is a world-class supplier of Bulk Active Ingredients including corticosteroids, hormonal steroids, antibiotics, and sterol intermediates. PCS production is based on soy sterol bioconversion and innovative chemical synthesis.
Read more
Shimadzu
Nexera X2 – X-ceptional insights
Ultra-high sensitivity, expanded flexibility, increased stability and robustness - the Nexera X2 UHPLC system targets routine analysis and applications in highly regulated environments demanding complex system setups. Read more
The Maltese Release Company
The Maltese Release Company (TMRC) is a recently established, privately owned company, located in Malta. TMRC provides access to testing and release services in any dosage form and offers you analytical method development and validation. Read more

Event Profile
Excipientfest
ExcipientFest Europe – 24 & 25 June, 2014 || Amsterdam
Marriott Hotel

ExcipientFest brings together experts from the excipients suppliers
and users community. The program is designed to share practical experience about topics related to the manufacture, use, regulatory compliance and future technologies of pharmaceutical excipients. The presentations and workshops will provide solutions based on guidelines and tools elaborated by IPEC Federation. Technical and scientific subjects will be discussed by various industry experts.
For more information, please contact Marisol Perez (marisol.perez@excipientfest.com) or visit www.excipientfest.com/europe
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Bioprocessing and Sterile Manufacturing
View technical articles on the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and more.Download Now

Reference Library

Pharmaceutical Technology Solid Dosage Combo
Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development. ... Click here


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