June 2010 contents - Archive by Issue - BioProcess International

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CMC Forum Press Releases

June 2010

June 2010, Vol.8 No.6

On the Cover

A photomicrograph of human mesenchymal stem cells after three days of hypothermic storage in HypoThermaSol medium.

FOCUS ON…

Measuring Manufacturing Cost and Its Impact on Organizations

Andrew Sinclair, Miriam Monge

BioProcess International, Vol. 8, No. 6, June 2010, pp. 10–14

Contractor Responsibilities in Outsourced Pharmaceutical Quality Control Testing

Raymond W. Nims, Elizabeth Meyers

BioProcess International, Vol. 8, No. 6, June 2010, pp. 16–20

BioProcess Technical

Practical Considerations for DoE Implementation in Quality By Design

Mahesh Shivhare, Graham McCreath

BioProcess International, Vol. 8, No. 6, June 2010, pp. 22–30

Fluorescence-Activated Cell Sorting for CGMP Processing of Therapeutic Cells

Catherine A. McIntyre, Brian T. Flyg, Timothy C. Fong

BioProcess International, Vol. 8, No. 6, June 2010, pp. 44–53

Technical BioProcess

The Roles of Bioactivity Assays in Lot Release and Stability Testing

Noel Rieder, Hélène Gazzano-Santoro, Mark Schenerman, Robert Strause, Chana Fuchs, Anthony Mire-Sluis, Lorna D. McLeod

BioProcess International, Vol. 8, No. 6, June 2010, pp. 33–42

Vendor Voice

I'm Losing Cell Viability and Function at Different Points in My Process, and I Don't Know Why!

Aby J. Mathew

BioProcess International, Vol. 8, No. 6, June 2010, pp. 54–57

Global Marketplace

BioProcess International, Vol. 8, No. 6, June 2010, p. 60

Global Meetingplace

BioProcess International Conference and Exhibition

BioProcess International, Vol. 8, No. 6, June 2010, p. 62

Elucidation

Single-Use Technology

Jerold Martin

BioProcess International, Vol. 8, No. 6, June 2010, pp. 64–65

Biopharmaceutical Production
Facility Design Strategies for Single-Use Technologies

Please join us for a free webinar addressing strategies for facility design in biopharmaceutical manufacturing:

Wednesday, 29 February 2012
8:00 AM and 1:00 PM EST

Presented by:

Ingrid Long, MSc
Research Engineer
GE Healthcare Life Sciences

During the webinar, Ms. Long will discuss the impact of different strategies for facility design, with a focus on the following topics:

* Replacement of traditional equipment with the single-use equivalent
* Biopharmaceutical manufacturing in a single room
* Benefits of facility design with respect to cost, risk, and flexibility

Editors' Blog

Biopharmaceutical Development and Production Week

Nine Conferences — One Location: Hilton Bayfront (San Diego, CA)

Development of a Plant-Made Pharmaceutical Production Platform

Recommendations for Cell Banks Used in GXP Assays

Efficient Aggregate Removal from Impure Pharmaceutical Active Antibodies

Implementation of Single-Use Technology in Biopharmaceutical Manufacturing

Production and Purification of a PER.C6-Expressed IgM Antibody Therapeutic

How QbD and the FDA Process Validation Guidance Affect Product Development and Operations, Part 2

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