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Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank Bioreactor

April 1, 2013

The authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.

Milestones and Moderate Progress in 2012 Drug Approvals

April 1, 2013

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

Managing Contract Manufacturing Organization Relationships

March 2, 2013

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

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.

CROs in a Global State of Mind

March 2, 2013

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

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.

Emerging Outsourcing Trends in 2013

March 2, 2013

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

Securing the Supply Chain

March 2, 2013

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

Overcoming Challenges in the Reconstitution of a High-Concentration Protein Drug Product

March 1, 2013

The authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.

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