Newsletter | June 19, 2014

06.19.14 -- Novartis Facility Licensed By FDA For Cell-Culture Flu Vaccines; Shire To Comply With FDA Request

Pharmaceutical Online Newsletter
Flexsafe: One Bag For All
Since Sartorius Stedim Biotech introduced the first single-use bag for biopharmaceutical applications, demand for them has rapidly increased for use in critical applications. Their robust performance and compliance are crucial for ensuring process safety and economy.

Now, we have developed a new polyethylene film and new bioprocessing bags that pave the way towards the single-use manufacturing facility of the future, and meet the most stringent customer needs for safe bioprocessing.
Learn more.
Featured Focus: Inspection
Validation Study Of The Vi-CELL XR For Automated Cell Counting Of Dendritic Cells
By Iveta Bottova, Ph.D., Beckman Coulter Life Sciences
Dendritic cells (DC) population is a key functional constituent of cell-based immunotherapy drugs. The correct cell count and adequate viability of DC are one of the quality control criteria for the final product release. Number of viable DC is historically determined by microscopy using a manual counting method — Bürker chamber and trypan blue dye for dead cell exclusion.
WHITE PAPER: The Challenges With Real-Time Viable Particle Counters
By Darrick Niccum, Senior Global Product Manager - Biotechnology, TSI Incorporated
While real-time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators. This article will address the unique challenges associated with evaluating, testing, and validating this new family of RMM instruments.
WHITE PAPER: QA/QC: Catching Up With The Competiton
By Robert G. McGregor, General Manager, Brookfield Engineering Laboratories, Inc.
In the world of pharmaceutical products, there is almost always a leader in every category of major application. Take skin creams, for example. The reputation is earned because the product solves the customer's problem, such as relieving facial acne or soothing aching joints. Working with the formulation chemists who create the product are the physical scientists, who specify how to process the material. They also have responsibility for characterizing the flow behavior of the cream when used by the customer and for specifying the QC test that verifies compliance.
WHITE PAPER: Introduction To Laser-Based Headspace Inspection Of Sterile Pharmaceutical Containers
PRODUCT: Visionspect Contract Visual Inspection Services
» Logistics
APPLICATION NOTE: 8 Steps To Mapping Validation Of A Chamber
CASE STUDY: Why Air Cargo Is A Viable Solution For Transporting Medical And Pharmaceutical Products
PRODUCT: Polar Pack Gel Packs And Foam Bricks
» Critical Environments
APPLICATION NOTE: The Benefits Of Machine Washing Laboratory Glassware Versus Hand Washing
By Lisa Choplo, Miele Professional
Hand washing not only presents inherent safety risks for employees, but is also not a repeatable process and produces variable results. Automating the washing process is one step that can be taken to modernize the laboratory and make it a safer and greener work environment.
DATASHEET: Tissue Culture CO2 Incubator
By NuAire, Inc.
PRODUCT: NanoPlus DLS Nano Particle Size And Zeta Potential Analyzer
» Manufacturing
APPLICATION NOTE: Activated Carbon Cartridges Evaluation And Scale-Up For Pharmaceutical Applications
By Thomas O'Brien, Ph.D., 3M Purification
Activated carbon in the pharmaceutical industry has been used for many years to reduce impurities derived from the reactions that create active pharmaceutical ingredients (APIs). The adsorptive properties and very large surface area of activated carbon make it ideal for filtering impurities from APIs, with decolorization being the most common pharmaceutical application.
DATASHEET: Klave-It: Autoclavable Bioprocess Containers
By Parker domnick hunter Process Filtration
BROCHURE: Cadence Single-Use Inline Concentrator
APPLICATION NOTE: Effect Of Bleaching On The Streaming Potential Of Human Hair
WHITE PAPER: Documentation Creation, Review, And Approval
DATASHEET: Luminox: Low-Foaming Neutral Cleaner
By Alconox, Inc.
» Packaging
BROCHURE: High-Speed Checkweighers
SERVICE: Pharmaceutical Manufacturing And Business Integration
VIDEO: Press Out Semiautomatic Deblistering Machine

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

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

The Seven Characteristics Of A World Class Supply Chain
Date: Tuesday, July 22, 2014 • Time: 1 pm to 2:30 pm EST
» Most Recent News
Shire To Comply With FDA Request To Test ADHD Drug On Preschoolers
FDA Lifts Partial Hold On Imetelstat Study
Sanofi And CQDM Enter Into Drug Discovery Agreement
Federal Judge Strikes Down Drug Discount Program
Novartis Facility Licensed By FDA For Cell-Culture Flu Vaccines
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