Newsletter | January 6, 2014

01.06.14 -- Shire's $120 Million Single-Use Gamble

Bioresearch Online Newsletter
Upstream Downstream Quality/Regulatory Supply Chain Integrity

Accelerated Regulatory Review: Tips To Speed Your Products To Market
Date: Wednesday, January 29, 2014 • Time: 1pm – 2:30pm EST

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 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
Featured Focus: Upstream
Shire's $120 Million Single-Use Gamble
By Rob Wright
Project Atlas is a 200,000 square foot biologics manufacturing facility. This facility is unique because its entire upstream line utilizes single-use systems, but what's more interesting is that the plant's $210M dollar price tag is $127.6M shy of the company's annual profit.
APPLICATION NOTE: Introduction To CHO Culture In A Stirred-Tank Bioreactor
By Richard Mirro, Eppendorf Inc.
This application report presents a simple protocol for achieving high-density culture of Chinese hamster ovary (CHO) cells using a New Brunswick™ benchtop autoclavable stirred-tank bioreactor.
APPLICATION NOTE: Amino Acid Fermentation: Evaluation Of Scale-Down Capabilities
APPLICATION NOTE: Reduce Cost, Increase Quality, And Shorten Cycle Time In Upstream Manufacturing-Scale Cell Culture
DATASHEET: GGsTop: Highly Selective GGT Inhibitor
By Wako Laboratory Chemicals
BROCHURE: Single-Use Depth Filtration: Zeta Plus
BROCHURE: New Paradigm For Process Optimization And Control
» Downstream
ARTICLE: Rapid Process Improvement Achieved By Applying A Rational Approach To Culture Media Optimization
By Tom Fletcher, Scott D. Storms, and Jenny Y. Bang, Irvine Scientific
The challenge of effective cell culture process development often involves how to simultaneously meet two competing needs: the need to maximize improvement of process performance and the need to minimize time spent on process development.
APPLICATION NOTE: Automated Cord Blood Cell Viability And Concentration Measurements Using The VI-CELL XR
By Stephen E. Szabo, Ph.D. and Sarah Monroe, B.S., Beckman Coulter, Inc.
Stem cells, due to their differentiation into mature blood cells, are the key to successful bone marrow transplantations. More recently, it has been found that umbilical cord blood is also a plentiful and rich source of hematopoietic stem cells.
APPLICATION NOTE: Integrate A Mixing System As A Slurry Tank When Packing Chromatography Columns
VIDEO: Genderless Sterile Connectors For Single-Use Bioprocessing Applications
POSTERS: Linear Scalability Of Virus Production From Bench-Scale To Industrial-Scale
POSTERS: How To Choose A Solid Carrier For Liquid Formulations
PRODUCT: HPLC Ion Exclusion Column
» Quality/Regulatory
ARTICLE: The New USP Chapter 41: Are You Compliant?
By Jennifer Camarda, Sales Specialist, Premium Balances and Software, Sartorius Corporation
As of December 1, 2013, significant changes to the USP Chapter 41, a mandatory chapter, became effective, and now apply to all materials that must be accurately weighed. USP Chapter 41 has also been renamed, from Weights and Balances to Balances, and it does not reference the minimum sample weight anymore, but rather it defines repeatability and accuracy, which specifies the operating range of a balance.
ARTICLE: New Draft Guidance On Quality Agreements: No Passing The Buck On cGMPs
By Cathy L. Burgess, Donald E. Segal, and Guillermo Cuevas, Alston & Bird LLP
Last month, the FDA released a draft guidance document entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements." The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use quality agreements to define responsibilities associated with manufacturing activities in a manner that is consistent with regulatory requirements.
DATASHEET: Biotest Laboratory Services
By STERIS Corporation
DATASHEET: NanoScan SMPS Nanoparticle Sizer 3910
By TSI Incorporated
DATASHEET: Miniature Spectrometer: AvaSpec-Micro
By Avantes BV
PRODUCT: Remove Potential Sample Loss And Damage: SampleGenie
PRODUCT: EZ BioPac: Powder Transfer Process
» Supply Chain Integrity
Q&A: Serialization Compliance: Will Pharma Be Prepared? Part Two
A Q&A With Chip Meyers, VP of UPS Corporate Public Affairs; and Tim Bishop, Manager of Healthcare Compliance, UPS
In part two of my interview, Chip and Tim share answers to their most-asked questions about serialization and how track and trace could impact supply chain integrity. They also weigh in on their concerns about the pharma industry's readiness from a logistics standpoint, as well as ways they can help manufacturers navigate the bumpy road toward serialization.
GUEST COLUMN: 5 Tips For Successful Cold Chain Logistics
By Dan Catizone, QuickSTAT
Cold chain shipments often have to be transported to obscure parts of the world under strictly controlled temperature conditions. Making sure that clinical specimens, vaccines, drugs, or other biologicals reach their destination safely, securely, and at the right temperature is a critical element of the drug discovery process. As a shipper, you need to ensure that your "cold chain" runs efficiently and with the least amount of adverse incidents.
ARTICLE: RAP e2 Shipping Larger Quantities More Efficiently
WHITE PAPER: Latin America Emerges As World Competitor For Global Trials Despite Tough Regulatory Environment
BROCHURE: Cargo Companion: Air Cargo Tracking Solution
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