Feature Articles - BioPharm International

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Feature Articles

Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process Considerations

June 1, 2014

USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.

Assuring Equivalency of Alternative Lot-Release Test Methods

June 1, 2014

New test methods can provide improved quality and efficiency, but they must be validated to demonstrate equivalency.

Weighing Clinical Trial Outsourcing Options

May 28, 2014

Evolving clinical trial research services give biopharmaceutical companies options for full- and functional-services.

Standardizing Practices for Disposables

May 1, 2014

Progress is being made in the development of harmonized best practices for single-use systems.

Regulatory Requirements for Viral-Challenge Studies: Influenza Case Study

May 1, 2014

Review regulatory requirements and the use of viral-challenge studies in drug development.

Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions

May 1, 2014

New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.

Improving Protein Expression with Novel Systems

May 1, 2014

New human and plant-based expressions systems can enable faster product development and improve quality at potentially lower costs.

India's Developing Market Offers Opportunities

May 1, 2014

Biopharma companies should not overlook India's growing market.

Accelerated Stability Modeling

May 1, 2014

Characterization of stability performance provides a clear, statistically defendable method for determining accelerated stability.

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