Feature Articles - BioPharm International

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Feature Articles

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.

India's Developing Market Offers Opportunities

May 1, 2014

Biopharma companies should not overlook India's growing market.

Raw Material Variability

April 1, 2014

The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.

Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material Considerations

April 1, 2014

USP evaluates raw materials used in the chemical synthesis of peptides.

Biopharmaceuticals Approval Trends in 2013

April 1, 2014

A review of the past year's trends in biopharmaceutical approvals shows an above average approval rate.

Global Instability Affects the Pharma Market in Brazil

April 1, 2014

How badly is Brazil's pharmaceutical market suffering from the global instability of emerging markets?

Implications of Trace Levels of Redox-Active Metals in Drug-Product Formulation

April 1, 2014

The presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.

Monoclonal Antibodies Key to Unlocking the Biosimilars Market

April 1, 2014

The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth.

Single-Use Technology for Syringe Filling

March 1, 2014

A novel approach to sterile drug product manufacturing that uses a single-use assembly in a multi-product final filling suite with isolator technology offers benefits of efficiency and flexibility.

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