Manufacturing

Angie Drakulich was editorial director of Pharmaceutical Technology.

Articles

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.

Platform Technologies

In a world where product recalls can mean the end of a company, all batches must be perfect.

Total Recall

Debottlenecking downstream mAb purification.

Single-Use High Capacity Membrane Chromatography

Combining olfactometry analysis with multidimensional gas chromatography–mass spectrometry provides an extremely useful analytical method for identifying aroma or odor notes from a sample.

An Analytical Technique for Identifying Tribromoanisole

The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.

The Determination and Control of Genotoxic Impurities in APIs

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

A recent industry survey shows keen interest in improving bioreactors and cell-culture media.

Wanted: Better Upstream Bioprocessing Technologies

Two popular methods for detecting protein aggregates are analytical ultracentrifugation (AUC) and size-exclusion chromatography?multiangle light scattering (SEC?MALS). These techniques? results correlate relatively well, but each one has its own strengths.

Analyzing Aggregate-Detection Methods

Many facilities buy compressed gas tanks or evaporate liquid nitrogen to supply processes with dry, high-purity nitrogen. An in-house nitrogen generator, however, provides several significant benefits.

In-House Nitrogen Generation Can Enhance Safety and Decrease Costs

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

What's More Important, the Process or the Product?

The authors describe the operational requirements and design of a process-ready PAT-based IBD system.

Manufacturing Equipment, Downstream Processing