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Correlating Product Lifecycle and Manufacturing Site Characteristics with Product Deviations

October 1, 2012

MIT survey results address product and site characteristics that statistically correlate with quality performance.

Report from India

October 1, 2012

India has enforced stricter patent laws compared to other countries. For a drug to be patentable in India, the invention has to be novel, inventive, and industrially applicable.

Considerations in Outsourced Vaccine Manufacturing

October 1, 2012

Marco Chacon of Paragon Bioservices discusses the challenges associated with outsourced vaccine manufacturing.

Key Considerations in Biosimilars Development

October 1, 2012

Understanding opportunities and challenges across all major phases of development.

A Manufacturing-Capacity Sharing Model

October 1, 2012

The manufacturing capacity-sharing model between Merck and MedImmune ushers in a new paradigm of "co-opetition."

Challenges and Opportunities for Biosimilars Developers

September 1, 2012

Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.

A Method for Removal of Endotoxin from Pharmaceutical Formulation

September 1, 2012

The authors describe a simple method to remove endotoxins from highly viscous formulations.

Bucking the Trend

September 1, 2012

A perspective on why platform processes are not and should not define the future of bioprocess development efforts. This article is part of a special section on biopharmaceutical trends.

Regulatory Challenges in the QbD Paradigm

September 1, 2012

The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.

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