Manufacturing Equipment, Downstream Processing

Critical issues that should be considered when scaling up a hot-melt extrusion process.

On Mar. 7, 2012, GE Healthcare announced an agreement to acquire Xcellerex, a supplier of manufacturing technologies for the biopharmaceutical industry, for an undisclosed amount.

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

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

Debottlenecking downstream mAb purification.

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

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

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

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.

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.

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

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

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.

The author proposes techniques, based on Six Sigma methods, for monitoring such processes to discover their airflow patterns and reduce opportunities for spillage.This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The authors describe the origins of single-use components and explain their application to aseptic processes. They also show how disposable devices have changed over time and offer a glimpse of the future.

Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.

Endotoxin removal from a finished product is a major challenge for biopharmaceutical manufacturers; particularly as all endotoxin removal methods have operational limitations and may result in loss of protein.

The spotlight on the biopharmaceutical industry is intensifying, as recently evidenced by Pfizer's (New York) ongoing acquisition of Wyeth (Madison, NJ), which was initiated partly to reduce the former's dependence on small-molecule drugs.

Ultra high performance liquid chromatography is advantageous in a contract laboratory because it is faster, more sensitive, and relies on smaller volumes of organic solvents than HPLC.

A book about pharmaceutical analysis engages the reader with history and unexpected asides.

A well-balanced guide to industrial bioseparations provides valuable information.

The authors review methods for reducing analysis time and increasing throughput that are reliable and maintain data integrity.

Polysaccharide-based chiral stationary phases have been developed that comprise chiral selectors immobilized on their support rather than being physically coated. These materials are completely solvent stable, thereby increasing selectivity and and enabling the development of new chiral selectors that have been too unstable in a coated form for general use.

The combination of supercritical fluid chromatography with chiral separation media offers several analytival advantages over traditional liquid chromatography techniques.

Ultrahigh pressure liquid chromatography maximizes efficiency, but, as defined by the resolution equation, the stationary phase is still a crucial consideration when attempting to resolve mixtures of compounds.

High performance liquid chromatography has become an efficient technique at the production scale, and simulated moving bed chromatography provides several benefits during processing.

Pharmaceutical Science & Technology Innovations

Pharmaceutical science & technology news.