BioPharm International-11-01-2012

BioPharm International

BioPharm International, November 2012 Issue (PDF)

November 01, 2012

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Biosimilars : New Guidelines Set for Monoclonal Antibodies

The Transformation to Process-Centered Organization

November 01, 2012

Manufacturing Best Practices

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Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

Considerations for Scale-Up of Stem-Cell Cultures

November 01, 2012

Features

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Scaling up stem-cell cultures requires careful consideration of the bioreactor design.

Creating a Holistic Procurement System

November 01, 2012

Perspectives on Outsourcing

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The procurement organization rethinks sourcing for maximum efficiency and results.

Product Characterization: A Primer

November 01, 2012

Boot Camp Technical Guide

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NIBRT's Jayne Telford provides an overview of biopharmaceutical analytics and their accompanying qualification and validation steps.

A 25-Year Retrospective on Protein Recovery through Membrane Filters

November 01, 2012

Features

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This month, Jerold Martin of Pall Life Sciences takes a look at protein recovery through direct-flow microporous membrane filters over the past 25 years.

Assay Development and Method Validation Essentials

November 01, 2012

Bioanalytical Best Practices

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A 10-step systematic approach to analytical method development and validation can improve the quality of drug development.

Discovery Pipeline: Improved Delivery of RNA Vaccines

November 01, 2012

Global Reports

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Creating an effective nucleic acid-based vaccine requires protecting the fragile nucleic acid from degradation, effective transfection of the targeted cells, and producing high enough levels of antigen to evoke a robust immune response.

How to Manage Effective Leadership when Change is the Only Constant

November 01, 2012

Final Word

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A disciplined approach to changing behavior can achieve change agility.

It's an Election Year.... Are You Making the Best Choices in Single-Use Tubing

November 01, 2012

Disposables Advisor

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The author considers the types of tubing available to the industry and how to make an informed selection.

Product Analysis Key to Biosimilar Development

November 01, 2012

Regulatory Beat

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Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.

EU Sets Guidelines for Biosimilar mAbs

November 01, 2012

Features

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The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs.

Stability in Biopharmaceutical Storage

November 01, 2012

Boot Camp Business Guide

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Patrick Jackson of Vindon Scientific offers key considerations for choosing an outsourced sample storage facility.

Report from Turkey

November 01, 2012

Global Reports

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The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East.

Knowledge is Power

November 01, 2012

From the Editor

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Global coordination tactics that incorporate online technologies and social media are reshaping disease prevention and response.

Connecting QbD, Knowledge Management, and Supplier Quality Management

November 01, 2012

Compliance Notes

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Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.

Evaluation of Single-Use Fluidized Bed Centrifuge System for Mammalian Cell Harvesting

November 01, 2012

Features

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This article discusses the evaluation of a novel single-use fluidized bed centrifuge for harvesting of antibodies.

Considerations for Scale-Up Stem-Cell Cultures

November 01, 2012

Features

25

11

Scaling up stem-cell cultures requires careful consideration of the bioreactor design.