Top Stories
Pfizer closes the acquisition of Hospira, adding sterile injectables business to portfolio.
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The platform, developed by Vectron Biosolutions, will be used for BI’s in-house pipeline and for its outsourcing clients.
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Industry News
The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.
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Worldwide, meetings take place for several reasons, such as to share new findings, learn about novel technologies, discuss international issues, exchange know-hows, and network, to name a few.
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Supplier News |
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This agreement is a follow-on to an established collaboration between LobSor and Recipharm for the development and the manufacturing of Lecigon batches for the recently completed clinical trial.
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The collaborative effort will be focused on fully humanized antibodies.
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Bio/Pharma News
Tuzistra XR for cough relief is said to be the only twice-daily, extended-release codeine-based cough and cold syrup available in the US.
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Regulatory News
The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.
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After many legal proceedings surrounding the first FDA-approved biosimilar, Zarxio officially launched commercially on Sept. 3, 2015.
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TROUBLESHOOTING
Appropriate cleaning procedures are crucial for any cGMP aseptic or sterile pharmaceutical manufacturing process, including vial filling; operators share best practices for cleaning.
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The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
In a market where high-demand causes organizations to seek software systems that will fit into their complex business infrastructure, the pressure to find the right system often causes angst to many.
Learn how to ensure that Quality and Compliance are met in the Life Science industry.
 Download guide now |
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AAPS 2015 Planning Guide
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Patheon, a business unit of DPx Holdings B.V., is a leading provider of contract development and commercial manufacturing services to the pharmaceutical and biotechnology sectors.
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Qualicaps Prism Capsules are empty two-piece capsules with a significant number of colorants and two ink formulations helping speed up development timelines.
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Ropack Pharma Solutions is a competitive, full-service CMO providing contract solid oral dose formulation, process development, clinical and commercial manufacturing and packaging as well as distribution.
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Widely recognized global supplier of two piece capsules, Suheung Capsule has solely focused on manufacturing the highest quality capsules.
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Waters Corporation creates business advantages for laboratory-dependent organizations by delivering practical and sustainable scientific innovation.
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Xcelience offers a suite of services enabling clients to partner with a single CDMO for all of their clinical outsourcing needs.
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Training Course - October 15-17 - Basics of Tablet Manufacturing and Troubleshooting;
Learn the basics of tablet shapes and design, tablet press setup & operation, tooling options and steel types, tool inspection, and tool reworking and polishing – with hands-on experience.
This course is designed for tablet compression industry professionals, including tooling technicians, tablet press operators, tablet press maintenance technicians, QC/QA personnel, research and development, and supervisors.
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Webcasts
On Demand
Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by Tosoh Bioscience LLC |
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Calibration and Qualification of Laboratory Instruments in Accordance with GMP Requirements
LIVE WEBCAST: Tuesday October 6, 2015 at 11 EDT/ 15:00 GMT/ 16:00 BST/ 17:00 CET
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.
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On Demand
Join our free webinar for a case study on the handling of complex manufacturing expansion projects, with insight on simulation and visualization tools, innovations for manufacturing of parenterals, effective team building, and more.
Sponsored by Baxter
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Fundamentals of Spray-Dried Dispersion Technology
Live Webcast: Thursday, September 17, 2015 at 15:00 CET | 9:00 am ET
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on pharmtech tv
Blow-Fill-Seal for Aseptic Processes
The Human Element in Pharma Manufacturing
Working with CMOs and CDMOs
The Transition from Paper Records to Electronic Batch Records
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Events
September 28–30, 2015 | Washington, DC, USA
September 28–30, 2015 | Las Vegas, NV, USA
October 25–29, 2015 | Orlando, FL, USA
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Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs
On Demand
Solubility enhancement expert Andreas Gryczke from BASF will share the latest insights into solubility improvement using simple and continuous processing technology twin-screw wet granulation.
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REFERENCE BOOKS |
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A compilation of informative, useful articles from Pharmaceutical Technology designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins
On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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