06.24.14 -- FDA Approval Pushes Novartis Into 21st Century Vaccine Development

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» From The Editor
FDA Approval Pushes Novartis Into 21st Century Vaccine Development
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
In 2009, the world experienced a global threat in the form of H1N1. Despite a prompt response to the need for a vaccine in the United States, it was still not available until six months later, and not enough doses were even produced to cover all Americans. During the year-long battle with the deadly virus, the CDC estimates between 8,870 and 18,300 people died due to H1N1-related complications. In the world of influenza vaccine production using chicken eggs, the response experienced during the H1N1 outbreak is not uncommon. Is this the best our industry can do? Novartis says NO.
Featured Focus: Supply Chain
Tips For Responding To FDA Form 483 Inspectional Observations
By Bruce McDuffee, Vaisala Life Science Division
According to the FDA document Investigations Operations Manual (IOM), the FORM FDA 483 INSPECTIONAL OBSERVATIONS is intended for use in notifying the inspected establishment’s top management, in writing, of "significant objectionable conditions, relating to products and/or processes, or other violations of the FD&C Act and related Acts which were observed during the inspection." This statement and other background information can be found in section 5.2.3 Reports of Observations of the IOM.
WHITE PAPER: 5 Most Logistically Challenging Biopharm Commodities
By Hervé Valler, Managing Director, France
For several years, the pharmaceutical industry has been moving away from primarily chemical and synthesized-based drugs and toward biologics. And while research and development is complex for all types of drug therapies, biologics have special challenges since they are made up of living microorganisms and cells. This is especially true where logistics is concerned — whether related to R&D, clinical trials, or ultimately, getting a drug to market.
WHITE PAPER: Temperature Mapping vs Temperature Monitoring: What's The Difference?
WHITE PAPER: Supply Chain Visibility Is A Key Part Of Delivering Proof Of Product Integrity
CASE STUDY: All-Season Containment Approach Maintains Product Integrity Even At Extreme Temperatures
» Critical Environments
WHITE PAPER: Ultraviolet Disinfection: Crucial Link In The Sterilization Chain
By Alex Verayo, Terra Universal
Many manufacturers face the challenge of maintaining sterile products and processes. In most cases, there’s no one-size-fits-all solution.
BROCHURE: CrimpLoc: Secure Closure Containment System
DATASHEET: Cleanroom Curtain System RVS
By M+W Group
WHITE PAPER: Is "Yield Stress" As Important As "Viscosity?"
By Robert McGregor, Global Marketing and High End Product Manager, Brookfield Engineering Laboratories, Inc.
“Yield stress” could be a term that applies to our daily lives. When under pressure, if the stress is too great, you start to “change” in a figurative sense. In the world of science and engineering, fluids and semi-solid materials that are subjected to a strong enough force will start to move. Basically, they “change” from their original shape and move in response to the applied force, remaining in motion as long as the force is great enough.
BROCHURE: Laser Diffraction Particle Size Analyzer
PRODUCT: Near-Infrared PAT System For Blend Uniformity Analysis For IBC Tumble Blending
» Packaging
CASE STUDY: Packaging Form Comparison: Bottelpack Bottle Versus Non-PVC Bags
PRODUCT: Island Placement: Eliminate Product Waste In Pharma And Medical Products
PRODUCT: Large Volume Pharmaceutical Parenteral Packaging Systems
» Manufacturing
WHITE PAPER: Reduce Cycle Times For Large-Capacity Mixing Applications
PRODUCT: Sterilization And Depyrogenation Ovens
» Inspection
DATASHEET: Pharmaceutical Flow Sensor
By Bürkert Werke GmbH
PRODUCT: X-Ray Inspection System: Dymond Series
PRODUCT: Used Checkweighers

FDA GMP Inspections: Proven Preparation And Survival Techniques
Date: Thursday, June 26, 2014 • Time: 1:00 pm to 2:30 pm EST

Process Validation Guide — Regulatory Expectations And Best Practices
Date: Wednesday, July 16, 2014 • Time: 1:00 pm to 2:30 pm EST

The Seven Characteristics Of A World-Class Supply Chain
Date: Tuesday, July 22, 2014 • Time: 1:00 pm to 2:30 pm EST
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