Newsletter | February 10, 2014

02.10.14 -- Industry Insights From The Executive Director Of Compliance At Seattle Genetics

Bioresearch Online Newsletter
Upstream Quality/Regulatory Downstream Supply Chain Integrity
Sartocheck® 4 Plus Bag Tester: Fully Automatic Bag Testing Device For 2D And 3D Bags
The Sartocheck® 4 plus Bag Tester is the result of a clear market need for testing single-use bags and bioreactors, pre- and post-use. The Sartocheck® 4 plus Bag tester is the perfect match for the BIOSTAT® STR, providing the tremendously valuable benefit of risk mitigation at a critical process step. Learn more.
» Featured Guest Column
"Women In Bio" Profile: Industry Insights From The Executive Director Of Compliance At Seattle Genetics
By Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader
From the time she was young, Kristin Rand's mother said she would be an actress or a lawyer. Although she thought her mother was probably correct, she didn't like the prospect of becoming either, merely because she did not want her mother to have predicted her future. While in high school she developed an interest in genetics, and the promise it held for the future of personalized medicine. Rand notes she always had an interest in the questions that science had not yet answered.
Featured Focus: Upstream
Fed-Batch Biofuel Production Process In A Stirred-Tank Fermentor
APPLICATION NOTE: Optimization Of Monoclonal Antibody Production Employing Noninvasive Sensor Technology
MAGAZINE: Your Partner In Bioprocessing: Single-Use Automation And Control
BROCHURE: Parallel Bioreactor Systems For Microbiology
PRODUCT: PerFix EXPOSE Cell Signaling Kit
PRODUCT: Cryogenic Microtubes
» Quality/Regulatory
ARTICLE: Simplify Metabolic Disease Complexity And Improve Clinical Success With Metabolomics
By Dr. Andrea Eckhart, Metabolon
Metabolic disease disrupts normal metabolism, resulting in altered systemic physiology. A challenge posed by metabolic diseases is that they are often present for years prior to becoming clinically apparent.
WHITE PAPER: Multivariate Data Analysis For Dummies
By Brad Swarbrick, CAMO Software
Welcome to Multivariate Data Analysis For Dummies, your guide to the rapidly growing area of data mining and predictive analytics. Multivariate analysis is set to change the mindset of many industries, and the way they approach the daunting task of analyzing large sets of data to extract the information they really need.
APPLICATION NOTE: Save Time And Costs In Biopharma Production With Fully Characterized And Certified Products
DATASHEET: Tri-Scale Sensor
By STERIS Corporation
BROCHURE: MiVac Centrifugal Concentrators
» Downstream
APPLICATION NOTE: Automation Of HTRF elF4E Kinase Assay Using A 3D Tumoroid-Based Cell
By Brad Larson, Peter Banks, Nicolas Pierre, and Grant Cameron
Three-dimensional (3D) cell culture is poised to meet the need for a more in vivo-like cellular model with which to test large and small molecules. This is accomplished by providing a method that allows for the reorganization of cells into a format which re-establishes the necessary cellular architecture and communication networks seen in normal tissue. Recently, a methodology has been put forth that incorporates a simplified procedure for the creation of a cell and collagen hydrogel mix. The inclusion of appropriate liquid handling instrumentations can further simplify the process, and ensure the generation of accurate, robust results.
DATASHEET: MPC/MPX Back-To-Back Body And Insert Adapters
By Colder Products Company
BROCHURE: MPC Ceramic Hydroxyfluoroapatite Chromatography Media
BROCHURE: Development And Commercial Services: Biopharmaceuticals
PRODUCT: BalanCD CHO Growth A Cell Culture Medium
PRODUCT: Integrity Bioprocess Vessels
PRODUCT: High-Quality Nutrient Media And Supplements
» Supply Chain Integrity
ARTICLE: New Regulations: Logistics And The Pharmaceutical Supply Chain
By Jeff Clark, 7P Solutions™, LLC
The transportation and logistics world is accustomed to complying with regulations — from the Department of Transportation (DOT), to the International Air Transport Association (IATA), as well as country-specific import and export regulations. With the implementation of Good Distribution Practices (GDP) in the European Union, it is inevitable that the U.S. will follow suit, and the Food and Drug Administration (FDA) will adopt GDP as well. This is the foundation for securing the "identity, strength, quality, and purity" of all pharmaceutical products as defined in 21 CFR Part 211, Current Good Manufacturing Practices for Finished Pharmaceuticals (cGMP).
ARTICLE: Supply Chain Visibility Is A Key Part Of Delivering Proof Of Product Integrity
BROCHURE: Event-Based Asset Tracking Solution
PRODUCT: SPS: Insulated Pallet Shippers
» Most Recent News
FDA Expected To Address Off-Label Marketing
Pfizer's Breast Cancer Drug Trial Deemed A Success
Merck And Ablynx Sign Global Cancer Immunotherapy Agreement Worth Up To $2.3B
AstraZeneca Announces Acquisition Of All Bristol-Myers Squibb Diabetes Alliance Interests
Mylan Subsidiary Launches First Trastuzumab Biosimilar Hertraz In India

CRA Oversight: A Risk-Based Approach
Date: Tuesday, February 11, 2014 • Time: 1pm – 2:30pm EST

Quality By Design (QbD) In Clinical Trials: Build Bullet-Proof Protocols
Date: Tuesday, February 18, 2014 • Time: 1pm – 2:30pm EST
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