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Milestones and Moderate Progress in 2012 Drug Approvals

April 1, 2013

First gene therapy and plant-based expression vector products approved in 2012.

Custom-Cell Products: Diversified In Vitro Models

April 1, 2013

The author outlines the need for custom-cell products.

Securing the Supply Chain

March 2, 2013

A Q&A with SAFC and BioReliance about sourcing and risk mitigation for raw materials.

Emerging Outsourcing Trends in 2013

March 2, 2013

BioPlan's outsourcing survey gives insight on top activities, budgets, and growth trends in biopharmaceutical outsourcing.

Achieving More Effective and Efficient GMP Auditing

March 2, 2013

The authors present solutions based on a review of current service offerings and their audit experience.

Quality and Regulatory Leadership: Right-Sizing Need and Cost

March 2, 2013

This article examines the options to best match needs and spending for quality and regulatory leadership.

Managing Contract Manufacturing Organization Relationships

March 2, 2013

Successful management of the CMO/client relationship should include open communication and trust.

CROs in a Global State of Mind

March 2, 2013

CROs are keeping pace with the increased globalization of the biopharmaceutical/pharmaceutical industry.

The Lifecycle Change of Process Validation and Analytical Testing

March 1, 2013

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

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