Manufacturing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

35th Anniversary Special: The Today and Tomorrow of Process Analytical Technology

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.

Industry wants more innovation, but can suppliers meet customer needs?

Biomanufacturing Innovation

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

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.

Process Analytical Technology-Based In-Line Buffer Dilution In Downstream Bioprocessing

US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments? suitability for this application.

Manufacturing, Process Chromatography