BioPharm International-06-01-2010

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BioPharm International, June 2010 Issue (PDF)

June 1st 2010
ArticleIssue PDF

Optimize Processes by Using CoGs Modeling

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Manufacturers, FDA Seek to Secure Supply Chains

Jill Wechsler
June 1st 2010
ArticleRegulatory Beat

International outsourcing and rising theft spur regulatory action and manufacturer oversight.

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The Effect of Thermal Cycling on Clamp-Type Fittings

Michael Bridge
June 1st 2010
ArticleFeatures

How to control compressive loads on seal materials.

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Five Things Every Biotech Company Must Know About Biosimilars

Stacie L. Ropka;Jonathan Harris
June 1st 2010
ArticleFinal Word

The new US legislation will forever alter the commercial landscape for biologics.

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Large-Scale Freezing of Biologics: Understanding Protein and Solute Concentration Changes in a Cryovessel—Part I

Satish K. Singh;Parag Kolhe;Alanta Lary;Steven Chico;Elisabeth Holding
June 1st 2010
ArticleFeatures

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Out of Nowhere: Do You Need to Prepare for Highly Improbable Situations?

Jim Miller
June 1st 2010
ArticleOutsourcing Insights

Being open to unforseen events may avert risk or create opportunities.

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The New Normal

Laura Bush
June 1st 2010
ArticleFrom the Editor

New R&D models must be tried, but it will take time to see if they work. In the meantime, a new kind of threat is on the horizon: biobetters.

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Biopharmaceutical Facility Cleaning Validation Using the Total Organic Carbon Test

Alexis Musacchio Lasa;Leopoldo Núñez de la Fuente;Julio César Sánchez García;Meily Sánchez;Luciano Hernández;Raudel Sosa Echagarruga;Marbel Ramos Alfonso;Rebeca Bouyon Albarran
June 1st 2010
ArticleFeatures

Case studies show TOC is effective for cleaning validation.

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Will Protein A Be the Long-Term Solution for Your Purification Needs?

Eric Langer
June 1st 2010
ArticleDownstream Trends

Biomanufacturers and vendors are now exploring more cost-effective purification technologies.

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Cost of Goods Modeling and Quality by Design for Developing Cost-Effective Processes

Hervé Broly;Matteo D. Costioli;Clémentine Guillemot-Potelle;Christine Mitchell-Logean
June 1st 2010
ArticleFeatures

Combine cost analyses with QbD to improve operations and lower costs.

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