Germany Post AMNOG: Insights for BioPharma
The authors take a look at some of the recent developments in the German pharmaceutical market.
Standardizing Practices for Cellular Therapy Manufacturing
Cellular therapy developers learn process development strategies from pharma industry experiences.
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Outside Looking In
European CDMOs want into the US market, but entry options are limited.
Cell Culture Consumables Prevent Contamination
Eppendorf's Cell Culture Consumables have an ISO class/GMP class C clean room production standard.
Hype vs. Health
Ebola Virus Disease (EVD) is a severe, often fatal disease that is transmitted human-to-human through bodily fluids.
New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
DoE Provides Benefits, but Preparation Is Necessary
Defining critical parameters and processing large quantities of data can be a challenge.
Vector Manufacturing and Testing for Gene and Cell Therapy Applications
The authors offer insight into cell therapy manufacturing, vector production, and the safety aspects of testing for characterization.
Developing Representative Sampling Plans for Development, Problem Solving, and Validation
The ability to define a scientifically justified and statistically sound sampling procedure is a fundamental skill in modern systematic drug development.
BioPharm International, November 2014 Issue (PDF)
Click the title above to open the BioPharm International November 2014 issue in an interactive PDF format.
