BioPharm International, February 2013 - BioPharm International

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BioPharm International, February 2013
Features
Viral Vaccine Manufacturing
Tony Hitchcock of Cobra Biologics discusses challenges posed by production of viral vectors for vaccines.
The Vaccine Scene
By Jose Castillo, PhD
A look at vaccine history, markets, manufacturing, and overcoming the scale-up dilemma.
Automated Concentration and Diafiltration of Multiple siRNA Samples
By Rebecca Arvary , Deborah R. Cohen , Steven Vaughan , Catherine Blake
Project: transfer a manual concentration/diafiltration process for siRNA production.
Assessing Development Needs for Biobetters and Biosimilars
By Christina Satterwhite, PhD
Development requirements and regulatory guidance for biosimilars and biobetters.
Therapeutic Antibodies in Review
By K. John Morrow, Jr., PhD , Rathin C. Das, PhD
Innovative products and a range of indications drive the therapeutic antibody market.
Navigating Emerging Markets: Eastern Europe
By Jill E. Sackman, PhD
Eastern Europe is moving towards a goal of harmonized regulations.
Guest Editorial
Offering a Biopharma View of Social Media
By Aaron Davidson
Ever since Twitter launched in 2006 and Facebook became mainstream, most industries have sought ways to connect with their consumers through social media.
Global Reports
Report from India
By Jane Wan
India's biopharmaceutical industry is valued at $2 billion a year with 20 companies producing biosimilars and 50 products available in the domestic market.
Regulatory Beat
GMP Compliance Becomes Prominent Enforcement Issue
By Jill Wechsler
Shortages spur efforts to overhaul manufacturing oversight.
Perspectives on Outsourcing
End of the Dedicated CMO?
By Jim Miller
Is the contract-only CMO an endangered species?
Boot Camp Business Guide
Facility Design and Operation: A Primer
NIBRT's Michael Lacey provides an overview of biopharmaceutical facility design and operation.
Manufacturing Best Practices
Relevance Regained
By Simon Chalk
Improvement strategy should be linked to business strategy.

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