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April 2012 Editorial Line-up
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PEER-REVIEWED
Development of an Alternative Monoclonal Antibody Polishing Step using Sartobind STIC Membrane Chromatography
Yun (Kenneth) Kang, Stanley Ng, Julia Lee, Josaih Adaelu, Bo Qi, Dale Ludwig
and Paul Balderes, ImClone System Corporation Eli Lilly and the Company
In many mAb purification platforms, traditional anion exchange column chromatography or, increasingly, anion membrane chromatography is used as a polishing step in a product flow-through mode to bind trace levels of process or product related impurities and assure efficient viral clearance. Anion exchange chromatography is however limited by the requirement for low loading buffer conductivity to efficiently remove impurities, which necessitates buffer exchange or dilution of the protein A column eluate. In this study we developed a mAb polishing step using membrane chromatography. The step can be easily integrated into most mAb purification platforms and may shorten mAb purification processes and accelerate development programs. |
Knowledge Management Implementation in a Biopharmaceutical Company
Tarun Jain and Bipul Pandey , Tata Consultancy Services Limited
Parliament Street, New Delhi
Knowledge management is one of the most important systems for any biopharmaceutical company. Knowledge management is considered a vital connection to other management subsystems in an organization. This paper focuses on the steps needed for successful implementation of knowledge management in a biopharmaceutical company. The approach to implementation discussed in the paper enables new possibilities for usage and exploration of valuable information existing in the company. Electronic Document Management System are discussed as well. |
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Editorial Theme: Outsourcing
Product & Services Spotlight: Outsourced Services |
25th Anniversary Retrospective: GMP Compliance
Each issue of BioPharm International in 2012 will feature a unique retrospective article from the publication’s first volume. This month, we rewind to an article on GMP Training Compliance programs and how they were run 25 years ago, compared with today. |
Special Section: Advances in Separation and Purification
BioPharm International speaks with key experts in the areas of separation and purification technologies to gain insight on key technical challenges including single-use components, protein chromatography, and more.
Participants include representatives Sartorius Stedim Biotech; Pall Life Sciences; 3M Purification, and Bio-Rad Laboratories.
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Formulation: Injectables
Self-administration therapies are changing the way the industry is approaching injectables. BioPharm International speaks with key experts on the formulation and delivery of self-administered injectable drugs.Participants include Steven Kaufman, SHL Group (Scandinavian Health Group); Mark Novara, BD; Charles Potter, Glide Pharma; and Peter Sadowski, Antares Pharm. |
BootCamp: Business and Technical Guides
Introducing BioPharm International’s basic training for drug development and manufacture, the journal will be featuring regular articles on how biotech companies can move a drug from discovery into development and manufacture. This month, we provide a look at driving business efficiency and value during strategy pipeline planning, featuring Tarja Mottram, CEO of Action for Results. |
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From the Editor |
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Global News |
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Regulatory Beat |
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Perspectives on Outsourcing |
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Manufacturing Best Practices |
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Compliance Notes |
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Product Reviews and Highlights |
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Final Word |
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