BioPharm International-05-01-2015

Meissner’s single-use biocontainer, FlexGro, is designed for use with rocker-style bioreactors.

While the United States and Europe still dominate, CMOs and CROs based in emerging markets continue to capture market share.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.

Higher cell densities, greater demand for high-performance viral clearance, and desire for large-scale single-use technologies are driving development of filtration technologies.

Manufacturer supply chain needs are changing in response to widening product temperature ranges.

Industry and regulatory agencies continue to make progress in establishing quality metrics for the pharmaceutical industry.

The rapid testing of biologic raw materials can lead to greater efficiency.

Integrating advances in facility design can meet differing and emerging bioprocessing needs.

ITT’s Pure-Flo EnviZion valve is designed with tool-less installation capabilities and lessened maintenance time.

The biopharma industry has had some successes but still needs to work on operational issues.

Differentiation and Characterization of Protein Aggregates and Oil Droplets in Therapeutic Products

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