BioPharm International, November 2012 - BioPharm International

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BioPharm International, November 2012
Features
EU Sets Guidelines for Biosimilar mAbs
By Sean Milmo
The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs.
Considerations for Scale-Up of Stem-Cell Cultures
By Matthieu Egloff , Jose Castillo, PhD
Scaling up stem-cell cultures requires careful consideration of the bioreactor design.
Evaluation of Single-Use Fluidized Bed Centrifuge System for Mammalian Cell Harvesting
By Hsu-Feng Ko , Ravi Bhatia
This article discusses the evaluation of a novel single-use fluidized bed centrifuge for harvesting of antibodies.
A 25-Year Retrospective on Protein Recovery through Membrane Filters
By Jerold Martin
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.
From the Editor
Knowledge is Power
By Angie Drakulich
Global coordination tactics that incorporate online technologies and social media are reshaping disease prevention and response.
Global Reports
Discovery Pipeline: Improved Delivery of RNA Vaccines
By Amy Ritter, PhD
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.
Report from Turkey
By Sean Milmo
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.
Regulatory Beat
Product Analysis Key to Biosimilar Development
By Jill Wechsler
Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.
Perspectives on Outsourcing
Creating a Holistic Procurement System
By Gregg Brandyberry
The procurement organization rethinks sourcing for maximum efficiency and results.
Compliance Notes
Connecting QbD, Knowledge Management, and Supplier Quality Management
By J. Paul Catania
Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.
Disposables Advisor
It's an Election Year.... Are You Making the Best Choices in Single-Use Tubing
By Jerold Martin
The author considers the types of tubing available to the industry and how to make an informed selection.
Boot Camp Technical Guide
Product Characterization: A Primer
NIBRT's Jayne Telford provides an overview of biopharmaceutical analytics and their accompanying qualification and validation steps.
Boot Camp Business Guide
Stability in Biopharmaceutical Storage
Patrick Jackson of Vindon Scientific offers key considerations for choosing an outsourced sample storage facility.
Bioanalytical Best Practices
Assay Development and Method Validation Essentials
By Thomas A. Little, PhD
A 10-step systematic approach to analytical method development and validation can improve the quality of drug development.
Manufacturing Best Practices
The Transformation to Process-Centered Organization
By Simon Chalk
Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?
Final Word
How to Manage Effective Leadership when Change is the Only Constant
By Tracy Thurkow , Karen Gorman , Paula Butte
A disciplined approach to changing behavior can achieve change agility.

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