Newsletter | June 17, 2014

06.17.14 -- Eli Lilly Navigates The Realities Of Innovation; X-Chem And Pfizer Sign Multi-Target Collaboration Agreement

Pharmaceutical Online Newsletter
Outsourced Pharma West Conference And Exhibition
November 10 and 11, 2014
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» Magazine Article
Eli Lilly Navigates The Realities Of Innovation
By Wayne Koberstein, Executive Editor
You have seen the headlines, reading them like obituaries for the about-to-be departed. You know the drill: repeated failures in Phase 3, nothing to replace the big earners with vanishing patents, mental images of a ship lost at sea. So why is Eli Lilly & Company still here — sailing the same course, undiverted, undiluted, and seemingly undeterred as the uniquely independent Midwestern-based company it has always been?
Featured Focus: QA/QC
Nutraceutical Powders Need Quality Control: Catching Up With The Competition
By Vinnie Hebert, Product Manager, Brookfield Engineering Laboratories, Inc.
Nutraceutical powders are like pharmaceutical powders in many aspects. There is an active ingredient (or ingredients) with a host of excipients.
ARTICLE: Improving Computerized System Quality Through Design Verification
By Mike Byrd, Director of Computer System Validation, ProPharma Group
While documented cost estimates may vary for correcting software/system defects in early versus late phases of the life cycle (10 to 100 times), the fact remains that formalized design verifications can be an effective tool in improving software quality. In regulated environments this can translate into improved compliance, enhanced data integrity, and ultimately. patient safety.
WHITE PAPER: Facing The Challenges: Single-Use Approaches To Powder Transfer
By Chris Rombach, ILC Dover
Media and buffer preparation is a key part of the biopharmaceutical manufacturing process, and while it doesn't have to be carried out in sterile conditions, improving the powder transfer process makes this step cleaner, safer, more efficient, protects personnel, and could cut time and costs as well.
WHITE PAPER: A Statistical Approach To Expanding Production Capacity
By Annette Kaya, Andrea Uebele, Anke Seeger, et al., M+W Process Industries
Contract manufacturer DSM Biologics, at its current good manufacturing practices (cGMP) facility in Groningen, The Netherlands, provides services for clinical development and commercial production based on mammalian cell culture technology.
PRODUCT/SERVICE: Flexsafe Single-Use Bags
» Inspection
WHITE PAPER: Tablet Dedusting: Which Method Fits Your Process?
By Andre Petric, President, Kraemer USA
There are a number of things to consider when integrating a deduster into your manufacturing line.
DATASHEET: Low-Profile Hygienic Floor Scale: IF Series
By Sartorius Intec
BROCHURE: Why You Should Be Using Ultrasonic Cleaning
» Supply Chain
BROCHURE: AT&T Cargo View With FlightSafe
PRODUCT: Via Prequalified Universal Insulated Shipper
UPCOMING EVENT: Bringing The Clinical Trial To The Patient
» Critical Environments
APPLICATION NOTE: Effective Cleaning Of BOD Bottles
DATASHEET: Labgard NU-819: Class I Vented Balance Enclosure
By NuAire, Inc.
PRODUCT: Pall Micro-24 Gas Micro Mixer
» Packaging
CASE STUDY: Recloseable Multidose Containers From Bottelpack Blow/Fill/Seal Aseptic Machines
BROCHURE: Pharmaceutical And Medical Device Applications Guide To Vision
PRODUCT: Overseal Capping System For Vials And Bottles
» Manufacturing
APPLICATION NOTE: Calculating High-Pressure Isosteric Heats Of Adsorption From HPVA Data Using MicroActive
BROCHURE: Process Optimization And Scale-Up Of Freeze-Dried Products
PRODUCT: Endotoxin Removal Cartridges And Capsules
» Most Recent News
Cellectis And CELLforCURE Sign Into Manufacturing Agreement
X-Chem And Pfizer Sign Multi-Target Collaboration Agreement
Takeda Launches Ulcer FDC Tablets In Japan
EffRx Signs Agreement For Binosto Distribution In Russia And Africa
FDA Accepts Expanded Label For Teva's Azilect In Parkinson's Disease
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