BioPharm International, June 2010 - BioPharm International

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BioPharm International, June 2010
Features
Large-Scale Freezing of Biologics: Understanding Protein and Solute Concentration Changes in a Cryovessel—Part I
By Parag Kolhe , Elisabeth Holding , Alanta Lary , Steven Chico , Satish K. Singh
Cost of Goods Modeling and QbD for Developing Cost-Effective Processes
By Matteo D. Costioli , Clémentine Guillemot-Potelle , Christine Mitchell-Logean , Hervé Broly
Combine cost analyses with QbD to improve operations and lower costs.
Biopharmaceutical Facility Cleaning Validation Using the Total Organic Carbon Test
By Julio César Sánchez García , Raudel Sosa Echagarruga , Meily Sánchez , Rebeca Bouyon Albarran , Luciano Hernández , Marbel Ramos Alfonso , Alexis Musacchio Lasa , Leopoldo Núñez de la Fuente
Case studies show TOC is effective for cleaning validation.
The Effect of Thermal Cycling on Clamp-Type Fittings
By Michael Bridge
How to control compressive loads on seal materials.
Regulatory Beat
Manufacturers, FDA Seek to Secure Supply Chains
By Jill Wechsler
International outsourcing and rising theft spur regulatory action and manufacturer oversight.
Outsourcing Insights
Out of Nowhere: Do You Need to Prepare for Highly Improbable Situations?
By Jim Miller
Being open to unforseen events may avert risk or create opportunities.
Downstream Trends
Will Protein A Be the Long-Term Solution for Your Purification Needs?
By Eric S. Langer
Biomanufacturers and vendors are now exploring more cost-effective purification technologies.
From the Editor
The New Normal
By Laura Bush
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.
Final Word
Five Things Every Biotech Company Must Know About Biosimilars
By Jonathan Harris , Stacie L. Ropka
The new US legislation will forever alter the commercial landscape for biologics.
Feature
What the Pharmaceutical Industry Can Learn from Toyota's Recalls: 12 Lessons of What to Do and What Not to Do
By Robert N. Borghese
The pharmaceutical and medical device industries can learn from Toyota's recalls to avoid their own "runaway" quality problems.

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