Newsletter | August 5, 2014

08.05.14 -- PhRMA, U.S. Biopharma Companies Partner For Arthritis Treatment R&D; Pfizer To Acquire Baxter's Commercial Vaccines

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.
» Guest Column
The Falsified Medicines Directive: What Does It Really Mean?
By Suzanne Elvidge, Contributing Editor
The trade in falsified medicines — medicines that look real but really aren’t what they seem — is a huge and growing one, and it is putting patients’ health and even their lives at risk. Along with regulatory authorities around the world, the European Union is putting directives into place that could begin to slow this deadly trade.
Featured Focus: Logistics
The Urgent Need For Qualified Transportation Providers
Dr. Rüdiger Lomb, World Courier
Given the high cost of conducting global clinical trials and the even higher cost of failure, regulatory agencies and pharmaceutical companies alike now demand that every party involved in the pharmaceutical supply chain — transportation and logistics providers included — conform to GxP guidelines.
WHITE PAPER: New Investments In Asia Enable Envirotainer To Respond To High Market Demand
WHITE PAPER: Mean Kinetic Temperature (MKT): A False Sense Of Security
VIDEO: Comprehensive Supply Chain Integrity Solutions
PRODUCT: PureTemp: Phase Change Materials (PCMs)
» Manufacturing
ARTICLE: PAT For Freeze Drying: Cycle Optimization In The Laboratory
By Dr. Henning Gieseler, PhD., Department of Pharmaceutics, University of Erlangen-Nuremberg
Freeze drying is generally known to be a time-consuming and therefore expensive process. In order to lower costs during manufacturing, the effective cycle time must be reduced. This goal can be achieved by optimizing a freeze-drying cycle in the laboratory — in particular the primary drying phase. Applying PAT (process analytical technology) in the laboratory can provide valuable information about product and process behavior and may help to identify the critical process parameters during cycle development and optimization.
DATASHEET: Emphaze AEX Hybrid Purifier
By 3M Purification
PRODUCT: High-End Fixed Industrial Vacuum: VHW311
» Inspection
WHITE PAPER: Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharmaceutical Liquids
By Chuck Reed, Weiler Engineering, Inc.
PRODUCT: Multisizer 3 Cell Counter: Ultra-High Resolution And Multiple Channel Analysis
PRODUCT: Pharmaceutical Contract Packaging Technology
WHITE PAPER: Rupture Test: A Quick And Easy Way To Avoid Soft Gel Capsule Failure
BROCHURE: EMC Documentum Quality Manufacturing Solution For Life Sciences
PRODUCT: Biological Safety Cabinets: Class I And Class II
» Packaging
DATASHEET: Formed Packs With Water-Soluble Film
By Harro Höfliger Packaging Systems
BROCHURE: Leak Testing Equipment For Packaging And Closure Containers
BROCHURE: Design, Create, And Manufacture Packaging In The Lab: EZ MedPak
» Critical Environments
Q&A: 5 Glassware Washing Concerns For Drug Development Labs
A Q&A with James Espiritu, Laboratory Equipment Business Applications Manager, Miele
As in any analytical lab, cross-contamination due to improper glassware washing is one of the major sources of experimental error in a drug development lab. The good news is that cross-contamination is totally preventable and it is possible to have excellent control over the glassware washing operation using a properly validated, sophisticated lab washer.
BROCHURE: Single-Source Isolation Technologies
PRODUCT: Modular Pharmaceutical Cleanroom Pass-Throughs
ChemOutsourcing is the largest U.S.-based API show, attracting annually 700 to 800 chemists from the pharmaceutical, biotech, and chemical industries. The show focuses on API development spanning early drug discovery through chemical development and commercial supply. Attendees are executive scientists from pharmaceutical companies responsible for sourcing starting materials, intermediates, and active ingredients, and experienced in working with contract research and contract manufacturing organizations. Learn more.

Improving Biological Facility Design: Critical Tips For Compliance
Date: Wednesday, August 6, 2014 • Time: 1:00 pm to 2:30 pm EST

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
Weekly FDA Enforcement Report For Drugs And Biologics 7/30/14
Pfizer To Acquire Baxter's Commercial Vaccines
PaxVax Acquires Typhoid Vivotif Vaccine, Swiss Plant
Thomson Reuters Recognizes World Hepatitis Day With Report On HCV Drugs
PhRMA, U.S. Biopharma Companies Partner For Arthritis Treatment R&D
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