Newsletter | August 14, 2014

08.14.14 -- How To Prepare A Facility For The Biopharmaceutical Revolution; What You Missed From The FDA Last Week

Pharmaceutical Online Newsletter
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By Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader
Angie Green, an external manufacturing and supply chain leader with 16+ years of experience, has a remarkable understanding of the sponsor/CMO relationship. Her presentation on the steps sponsors should follow when selecting CMO partners is so informative and are echoed in many of the conference sessions for Outsourced Pharma West Conference.

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» From The Editor
How To Prepare A Facility For The Biopharmaceutical Revolution
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. The Patheon facility, in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?
Featured Focus: Critical Environments
A Strategy For Implementing Rapid Microbial Methods
By Gilberto Dalmaso, Sterility Assurance Consulting, A&L Co
The purpose of this white paper is to present a strategy to be used and applied for rapid microbiological methods (RMM).
WHITE PAPER: When To Replace Your Biological Safety Cabinet
APPLICATION NOTE: Paperless Environmental Monitoring For Aseptic Pharmaceutical Manufacturing
By Bob Latimer, Beckman Coulter Life Sciences
Aseptically produced, parenterally administered biopharmaceutical products must be free of unwanted bacterial or viral contaminants.
BROCHURE: Handheld Raman Analyzer For Raw Materials Verification
BROCHURE: Compact Glassware Washer And Dryer
» Packaging
Leveraging Track-And-Trace Technology To Improve Packaging Line Quality
By Frank Bieganousky, Founding Member, Montesino Associates, LLCBy Frank Bieganousky, Founding Member, Montesino Associates, LLC
Whether it comes from the global market or a national regulatory body, implementing a track-and-trace system is a complex, expensive, and resource-intensive endeavor. It is complex since there are numerous technical and design challenges, expensive since it can involve many and varied pieces of equipment, and resource intensive since it needs cross-functional teams and top management involvement.
VIDEO: Packaged Product Inspection In Food And Pharma
PRODUCT: Pharmaceutical Filling Machine For Aseptic Bags
» QA/QC
WHITE PAPER: The Hidden Value Of Instrument Manufacturers
By Tara S. Hundley, Anton Paar USA
For those of you who work with any analytical, lab, or process instruments, you know that staying in compliance with global regulations has become burdensome in the past decade. Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the workflow as soon as possible; but to do so you need to know everything there is to know about equipment and instrument qualification. In the overall pharmaceutical manufacturing process you may be just one cog on the gear of productivity, but without some help, you could go from cog to clog very quickly.
BROCHURE: QUBE: Modular Biodecontamination System
PRODUCT: Data Analysis Consulting
» Manufacturing
APPLICATION NOTE: Mixing And Drying Of Granulations For Vitamin And Mineral Supplements
APPLICATION NOTE: Process Optimization Made Easy: DoE With A Multibioreactor System
APPLICATION NOTE: Metal Removal From Fine Chemical Products
» Logistics
WHITE PAPER: 5 Tips To Minimizing Risk In Your Cold Chain Packaging
By Jean Bédard, President and CEO, Infitrak
As pharmaceuticals have become more and more regulated, companies have had the need to build or evaluate their cold chain processes and packaging to comply with those regulations and minimize risk.
DATASHEET: Certis Qualified Shipping Series
By Sonoco ThermoSafe
PRODUCT: Handheld Vaccine Carriers
» Inspection
CASE STUDY: Risk Mitigation: Tablet Inspection Recalls
DATASHEET: In-Line Leak Testing Machine For Flow Wrapped Applications
By TASI Group: Bonfiglioli Engineering and Sepha
PRODUCT: Pharmaceutical Syringe Headspace Inspection
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UPCOMING TRAINING

Lyophilization: An Introduction To The Scientific Principles
Date: Wednesday, August 20, 2014 • Time: 1:00 pm to 2:30 pm EST
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What You Missed From The FDA Last Week — August 5-9, 2014
CPhI Pharma Awards Open For Entries, With New 'Innovation In Partnering' Category
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