January 2010 contents - Archive by Issue - BioProcess International

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CMC Forum Press Releases

January 2010

January 2010, Vol.8 No.1

On the Cover

Production vessels lined up in Roche’s biotech manufacturing plant, building #95, in Basel, Switzerland (winner of the 2009 ISPE facility-of-the-year award, announced in November). www.roche.com

Focus On…

COMPLIANCE

Hurry Up and Wait?

Michalle Adkins

BioProcess International, Vol. 8, No. 1, January 2010, pp. 10–16

BioProcess Technical

Improved HCP Quantitation By Minimizing Antibody Cross-Reactivity to Target Proteins

Xing Wang, Thomas Schomogy, Kristine Wells, Ned M. Mozier

BioProcess International, Vol. 8, No. 1, January 2010, pp. 18–24

Nutrient Supplementation Strategies for Biopharmaceutical Production, Part 3

Richard Fike

BioProcess International, Vol. 8, No. 1, January 2010, pp. 24–31

Primary Clarification of Very High-Density Cell Culture Harvests By Enhanced Cell Settling

Emily B. Schirmer, Michael Kuczewski, Kathryn Golden, Blanca Lain, Carissa Bragg, John Chon, Marco Cacciuttolo, Gregory Zarbis-Papastoitsis

BioProcess International, Vol. 8, No. 1, January 2010, pp. 32–39

Vendor Voice

PAT-Based In-Line Buffer Dilution

Thomas Malone, Michael Li

BioProcess International, Vol. 8, No. 1, January 2010, pp. 40–49

Global Marketplace

BioProcess International, Vol. 8, No. 1, January 2010, pp. 50–51

Global Meetingplace

Biopharmaceutical Development and Production Week

BioProcess International, Vol. 8, No. 1, January 2010, p. 52

Elucidation

Quantitative Crowdsourcing

Leslie Fine

BioProcess International, Vol. 8, No. 1, January 2010, p. 56

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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