BioPharm International-05-01-2015

BioPharm International

Biomanufacturing Outsourcing Globalization Continues

May 02, 2015

Perspectives on Outsourcing

28

5

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

Ensuring the Quality of Biologicals

May 02, 2015

Inside Standards

28

5

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.

How to Stay Abreast of Shifting Regulations and Remain Compliant

May 02, 2015

Compliance Notes

28

5

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

FDA Revises Field Inspections to Reflect Global Market and Quality Initiatives

May 01, 2015

Regulatory Beat

28

5

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

Filtration Technologies Advance to Meet Bioprocessing Needs

May 01, 2015

Features

28

5

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

An Update on the Quality Metrics Initiative

May 01, 2015

Features

28

5

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

Streamlining Raw Materials Testing

May 01, 2015

Features

28

5

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

Best Practices in Facility Design

May 01, 2015

28

5

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

Quality Counts, Too

May 01, 2015

From the Editor

28

5

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

BioPharm International, May 2015 Issue (PDF)

May 01, 2015

Issue PDF

28

5

Click the title above to open the BioPharm International May 2015 issue in an interactive PDF format.