BioPharm International, November 2014 - BioPharm International

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BioPharm International, November 2014
Cover Story
Vector Manufacturing and Testing for Gene and Cell Therapy Applications
By Wolf Klump , Martin Wisher , Alison Armstrong , Audrey Chang
The authors offer insight into cell therapy manufacturing, vector production, and the safety aspects of testing for characterization.
Standardizing Practices for Cellular Therapy Manufacturing
By Uplaksh Kumar, PhD , Naynesh R. Kamani, MD
Cellular therapy developers learn process development strategies from pharma industry experiences.
Troubleshooting
Viral Clearance Challenges in Bioprocessing
By Cynthia Challener, PhD
Challenges remain for virus removal and validation.
Features
Setting Standards for Biotech Therapeutics in India
By Anurag S. Rathore, PhD , Renu Jain , M. Kalaivani , Gunjan Narula , G. N. Singh
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
Germany Post AMNOG: Insights for BioPharma
By Jill E. Sackman , Michael Kuchenreuther
The authors take a look at some of the recent developments in the German pharmaceutical market.
DoE Provides Benefits, but Preparation Is Necessary
By Cynthia Challener, PhD
Defining critical parameters and processing large quantities of data can be a challenge.
Analytical Best Practices
Developing Representative Sampling Plans for Development, Problem Solving, and Validation
By Thomas A. Little, PhD
The ability to define a scientifically justified and statistically sound sampling procedure is a fundamental skill in modern systematic drug development.
Perspectives on Outsourcing
Outside Looking In
By Jim Miller
European CDMOs want into the US market, but entry options are limited.
Regulatory Beat
New Era for Generic Drugs
By Jill Wechsler
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
From the Editor
Hype vs. Health
By Rita Peters
Ebola Virus Disease (EVD) is a severe, often fatal disease that is transmitted human-to-human through bodily fluids.
Products
Cell Culture Consumables Prevent Contamination
Eppendorf's Cell Culture Consumables have an ISO class/GMP class C clean room production standard.

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