BioPharm International, June 2010

Features

The Effect of Thermal Cycling on Clamp-Type Fittings

By Michael Bridge

How to control compressive loads on seal materials.

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.

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.

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

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.