Newsletter | August 7, 2014

08.07.14 -- What You Missed From The FDA Last Week; Novartis Vaccinates Over 45K People In Bexsero Campaign

Pharmaceutical Online Newsletter
Life Science Leader and BayBio bring you interactive panels on the challenges to managing outsourcing relationships. Panelists include Andy Skibo (RVP, AstraZeneca; EVP, MedImmune), David Lowndes (SVP, Shire), Bob Kanuga (VP, Merck), Junning Lee (SVP, Theravance Biopharma), Terry Novak (COO, Pernix Therapeutics), and others. Learn more.
» Featured Article
Genzum Plies The Art And Science Of Scaling Up
By Wayne Koberstein, Executive Editor
Sometimes the smallest bits of evidence light up the largest theories. Like the infinitesimal traces of the Big Bang astronomers recently teased from cosmic background radiation — data showing the effects of gravitational waves in the universe at zero plus one-trillionth of a second — a single company case, stripped down to the bare essentials, can teach fundamental lessons about growth after start-up.
Featured Focus: Packaging
Four Reasons For The Rise In Blister Packaging
By Paul Dupont, Ropack, Inc.
Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17 percent of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook, compiled by GBI Research.
BROCHURE: Scan TVS Print Inspection
BROCHURE: Premium Stainless Steel Checkweigher
» Logistics
WHITE PAPER: Why A Closed-Loop Supply Chain System?
By Dr. Rüdiger Lomb, Global Director, Quality and Technical Compliance, World Courier
This article covers improving compliance and efficiency in the pharmaceutical supply chain with reduced cost and risk. How does the sponsor ensure that product transfer conforms to the same established written procedures demanded at the investigator level throughout the full length of the supply chain, or more specifically, while in the hands of non-pharmaceutical, non-investigator personnel?
WHITE PAPER: Securing Provision K Status For A Client's API Helps To Expedite Shipping And Reduce US Importation Costs
BROCHURE: AT&T mHealth Solutions
» Critical Environments
WHITE PAPER: Improving Uptime In Aseptic Processing Of Pharmaceutical Liquids
By Chuck Reed, Weiler Engineering, Inc.
Maximized uptime, minimized changeover time, and efficient OEE are key factors that have influenced the acceptance of aseptic blow-fill-seal in the packaging of pharmaceutical liquids.
APPLICATION NOTE: A New Single-Pass TFF Technology To Simplify Processes And Lower Costs
BROCHURE: SPECTester Material Segregation Tester
» Manufacturing
WHITE PAPER: How Online Viscosity Control Helps Manufacturing
By Robert G. McGregor, General Manager, Brookfield Engineering Laboratories, Inc.
The pharmaceutical industry typically employs the grab-sample technique to evaluate viscosity behavior of material in process. High-volume products such as cough syrup and skin lotions for sun protection are good candidates for “in-process” viscosity measurement because payback for equipment investment can be justified. Products produced in limited quantity should continue with the grab-sample approach.
APPLICATION NOTE: Improve Tablet Uniformity And Hardness While Reducing Friability And Variation
BROCHURE: Sartobind Ion Exchange Membrane Adsorber Capsules
BROCHURE: Isolation Technology
PRODUCT: Six-Glove Sterility Testing Isolator
WHITE PAPER: Be In Control Of Product Quality: Do Not Just Rely, But Understand
By Maik W. Jornitz, President, G-CON Manufacturing LLC
Past experiences have shown that too often product quality is based on sole reliance on vendor certifications, statements, and promises. To diminish such reliance, new technologies were implemented, such as process analytical technologies (PAT), process controls, automation, etc., often once again overexerted as the solution to all problems; activities that supposedly result in higher product quality due to better process controls.
DATASHEET: Pharmaceutical Flexible Isolator: FlexiVac
By ILC Dover
BROCHURE: Unscrambler X Classification Engine: Multivariate Analysis Software
» Inspection
BROCHURE: Veripac 410 Blister Leak Tester
PRODUCT: Pharmaceutical Syringe Headspace Inspection
PRODUCT: High-Voltage Leak Detector
Upcoming Event
October 27 to 29, 2014, The Ritz-Carlton, Laguna Niguel, CA
The #1 partnering event for the pharma and biotech industries.
Pharma/Biotechs: Get 25 percent off your registration with code BN14PHARMAO. Learn more.

Serialization Preparedness: What You Must Know For Bullet-Proof Programs
Date: Tuesday, August 12, 2014 • Time: 1:00 pm to 2:30 pm EST

Lyophilization: An Introduction To The Scientific Principles
Date: Wednesday, August 20, 2014 • Time: 1:00 pm to 2:30 pm EST
» Most Recent News
Dual-Shaft Mixers For Efficient Powder Dispersion And Temperature Control
Sanofi And Regeneron To Use Priority Review Voucher For Alirocumab
Malaria Drugs Eyed As Asthma Treatment, Liver Cancer Prevention Tactic
What You Missed From The FDA Last Week—July 28th-August 1, 2014
Novartis' Vaccinates Over 45K People In Bexsero Campaign
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