BioPharm International, November 2006

Features

Production Cost Analysis: Economic Analysis as a tool for Process Development: Harvest of a High Cell-Density Fermentation

By Anurag S. Rathore, PhD , Matthew Karpen

The number of biotechnology-based human therapeutic products in the late-stage pipeline, and the average cost to commercialize a biotech product, have steadily increased. This has required biotech companies to use economic analysis as a tool during process development and for making decisions about process design. Process development efforts now aim to create processes that are economical, as well as optimal and robust.

Specification Setting: Setting Acceptance Criteria from Statistics of the Data

By Terry Orchard

This article shows how Probabilistic Tolerance Intervals of the form, "We are 99% confident that 99% of the measurements will fall within the calculated tolerance limits" can be used to set acceptance limits using production data that are approximately Normally distributed. If the production measurements are concentrations of residual compounds that are present in very low concentrations, it may be appropriate to set acceptance limits by fitting a Poisson or an Exponential Distribution.

Downstream Processing: Improving Productivity in Downstream Processing

By Gail Sofer , Laura C. Chirica

Increased resin stability can extend the number of cleaning cycles that can be performed in situ.

Technology Transfer: How to Make It a Competitive Advantage

By Scott J. Mahoney , Anser F. Qureshi

If a company wants to reduce costs, it should consider outsourcing some manufacturing and analytical testing to low-cost sites.

Columns and Departments

Legal Forum: Patenting Strategies to Delay Biogeneric Competition

By Narinder Banait

In the US, the patent term is 20 years from the filing date . . . commercial product may lose patent protection just as sales are ramping up.

Regulatory Beat: Biotech Manufacturers Face Streamlined Inspection Programs

By Jill Wechsler

FDA is working more closely with foreign regulators to keep abreast of drug and vaccine quality issues in their regions.

From the Editor: We All Need Quality Systems Even at the Cellular Level

By Laura Bush

Whether it's for manufacturing drugs, characterizing cell substrates, or regulating new technology, quality systems provide a needed framework.

StreetTalk: Banking on a Pharma Giant

By Brian O'Connell

In the big pharma world, drugstore aisle space is every bit as important as Times Square is to New York real estate developers. And few pharma giants fill that space as well as GlaxoSmithKline.

Final Word: Outsourcing to Developing Countries

By Steven S. Kuwahara

In the rush to save money, the consequences of potential problems often are ignored.