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Challenges and New Technologies for Supply-Chain Management
Industry experts discuss new technologies and challenges associated with the pharmaceutical supply chain with a focus on cold-chain technologies. Participants include Merck, Georgia Tech Research Institute, Cold Chain Technologies.

Supply-Chain Standards
Dr. Desmond Hunt, United States Pharmacopeia Convention
USP gives an update on the latest supply-chain standards.

A Primer on Supplier Change Management for Pharmaceutical Drug Product Manufacture
Brian Trdina, MedImmune; Cynthia Pullinger, Baxter; Kevin Vermeulen Genzyme; Susan Grant, Merck; Alfred Keusch, Baxter; Jonathan Goetz, Baxter; Steve Jones, BPOG
The authors give an introduction and overview of the Pharmaceutical Supplier Initiated Change Process and discuss the need for control of SICs, a review of change notification scope and content, and a general overview of how SICs are typically evaluated, managed, and closed.

Evolution of the Monoclonal Antibody Purification Platform
Anurag S. Rathore, Vijesh Kumar, Department of Chemical Engineering, Indian Institute of Technology, New Delhi, India; Nihal Tugcu, Bioprocess Development, Merck & Company, Kenilworth, New Jersey, USA; and Ranga Godavarti, Bioprocess Research and Development, Pfizer, Andover, Massachusetts, USA
Monoclonal antibody (mAb) products increasingly form the majority share of pipeline as well as revenue of major biopharmaceutical companies. From a processing perspective, what is unique about them is the applicability of developing a common process and analytical platform. The authors discuss the evolution of the purification platform for manufacturing of monoclonal antibody therapeutics.

Boot Camp: Technical Guide- Best Practices in Implementing Single-use Systems
BioPharm talks with Saint-Gobain about how a single-use systems approach to implementing disposable technologies can open the door to greater efficiency.

Peer Reviewed: Metacomplex Formation and Binding Affinity of Multivalent Binding Partners
Sophia Kenrick, Ph.D, Application Scientist, and Daniel Some, Ph. D., Director of Marketing and Principal Scientist, Wyatt Technology, Corporation
This article highlights a study to investigate metacomplex formation in the hetero-association of a multivalent antigen, streptavidin (SA), and a bivalent antibody (Ab) using a CG-MALS system comprising a Calypso II composition gradient device, a DAWN HELEOS II MALS detector and a Waters 2487 UV/Vis absorption detector. The Calypso software provided macromolecular interaction models suitable for analysing this complicated interaction. The analysis indicated that SA and Ab associate into complexes with higher molecular weight than a simple 1:1 or 2:1 stoichiometry, including 2:2, 3:2 and 3:3 assemblies. Each complex was found to exhibit dynamic equilibrium with an affinity value of 23±4 nM. The higher-order stoichiometries, a consequence of the multivalent nature of the two binding partners, are naturally derived from the weight-average solution molar masses reported by MALS.