BioPharm International, November 2013 - BioPharm International

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BioPharm International, November 2013
Cover Story
Challenges in Managing the Cold Chain
By Susan Haigney
BioPharm International speaks with industry experts about challenges faced in managing the cold chain.
Peer-Reviewed Research
Metacomplex Formation and Binding Affinity of Multivalent Binding Partners
By Daniel Some , Sophia Kenrick
A study to investigate metacomplex formation in the hetero-association of a multivalent antigen, streptavidin (SA), and a bivalent antibody (Ab) using a composition-gradient multiangle light-scattering (CG-MALS) system consisting of a composition-gradient device, a MALS detector, and a UV/Vis absorption detector.
Features
Evolution of the Monoclonal Antibody Purification Platform
By Anurag S. Rathore , Ranga Godavarti , Vijesh Kumar , Nihal Tugcu
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Thermal Protection for Control-Room-Temperature Products
By Melissa Germain , Jean-Pierre Emond
The authors discuss how to develop a cost-effective thermally protective packaging system.
Supplier-Change Management for Drug-Product Manufacturers
By Steve Jones , Brian Trdina , Cynthia Pullinger , Kevin Vermeulen , Ewelina Flamm , Alfred Keusch , Jonathan Goetz
An effective supplier-initiated change management process is discussed.
USP Plans Standards on Good Distribution Practices
By Desmond Hunt
USP is developing and revising distribution standards in response to changes in the global supply chain.
Manufacturing Best Practices
Risk Aversion and Closed-System Processing
By Simon Chalk
Using closed systems opens up many new possibilities for how facilities are designed and operated and may also present lower risk to the operation and, ultimately, the product.
Regulatory Beat
Congress Revises Rules for Drug Compounding and Supply-Chain Security
By Jill Wechsler
Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.
European Beat
European Union Introduces GMPs for Excipients
By Sean Milmo
Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.
Perspectives on Outsourcing
Disposable Applications in Demand by Biopharma
By Eric Langer
Data from BioPlan Associates' 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.
Boot Camp Business Guide
The State of the Used-Equipment Market
By Tom Burton
Today, there is a global adoption of buying and selling used equipment. This article reviews what organizations should look for when considering the purchase of used equipment.
Global News
Report from Brazil
By Hellen Berger
New regulation offers patients in Brazil greater access to experimental drugs.
From the Editor
New Funding and Approval Pathways Prove Popular
By Rita Peters
The JOBS Act and FDASIA show early signs of accelerating drug development.

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