BioPharm International-11-01-2014

The authors take a look at some of the recent developments in the German pharmaceutical market.

Cellular therapy developers learn process development strategies from pharma industry experiences.

The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.

Challenges remain for virus removal and validation.

European CDMOs want into the US market, but entry options are limited.

Eppendorf's Cell Culture Consumables have an ISO class/GMP class C clean room production standard.

Ebola Virus Disease (EVD) is a severe, often fatal disease that is transmitted human-to-human through bodily fluids.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

Defining critical parameters and processing large quantities of data can be a challenge.

The authors offer insight into cell therapy manufacturing, vector production, and the safety aspects of testing for characterization.

The ability to define a scientifically justified and statistically sound sampling procedure is a fundamental skill in modern systematic drug development.

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