Articles on analytical & statistical methods, process analytical technology - BioPharm International

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Quality
Essential information about quality assurance and quality control, including analytical methods, analytical method development, statistical methods, and process analytical technology (PAT).

USAID Moves Global Healthcare Initiatives Forward

January 1, 2012

Government plans require investment, partnership, and industry collaboration.

Budget Crunch, Political Battles Shape Policy Agenda for Year

January 1, 2012

Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation.

Here's to a Year of Compromise

January 1, 2012

The benefits of harmonization may be on industry's wish list, but buying into change is another story.

A 25-Year Retrospective on Separations Technology

January 1, 2012

This month, we rewind to "Separations Technology Outlook, Part II: Improved Recovery and Greater Purity."

FDA Revamps to Meet New Challenges

December 1, 2011

Added responsibilities and outside concerns prompt overhaul of agency's structure.

Supporting Innovation Requires Consistency and Vision

December 1, 2011

Political leaders need to consider the impact of the biopharmaceutical industry on the economy.

CMOs Ratchet up use of Single-Use Devices to Improve Performance

November 1, 2011

Single-use systems continue to gain traction among biomanufacturers, especially CMOs.

Focus on Standardization, Quality by Design, and Regulatory GMP

November 1, 2011

In this quarter's column, highlights from the IBC Single-use Applications meeting, the PDA Single-use Workshop, and the BioProcess systems Alliance International Single-Use Summit are presented.

Integrity Testing of Flexible Containers

November 1, 2011

Defects as small as 10 μm can be detected without compromising product cleanliness using helium integrity testing.

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