Formulation and Process Development Articles

To commercialize DNA medicines, industrial plasmid DNA manufacturing processes that meet the quality, economy, and scale requirements projected for future products are needed. We have developed cell bank and fermentation process unit operation innovations that reduce plasmid-mediated metabolic burden, enabling improved upstream production of optimal plasmids to 2.6 g/L.

Throughout the industry, there are questions regarding when to integrity test filters in the purification and buffer preparation areas. This includes liquid filters as well as vent and air filters. The requirement to warrant a filter integrity test (FIT) is based on compliance with the validated claim of microbial retention and criticality of the filter performance.

The International Conference on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concepts to the manufacture of biotech products, however, involves some nuances and complexities.

Researchers at the Graduate School of Engineering at Nagoya University in Nagoya, Japan, recently reported that they developed an asymmetric catalyst that assembles spontaneously, a development that lays the groundwork for further designing functional supramolecular catalysts. Their work involved using chiral organic ion-pair catalysts assembled through a hydrogen-bonding network (1).

In the pharmaceutical industry, the three most common granulation processes for solid dosage form production are wet granulation, dry granulation (i.e., roller compaction), and direct blending. In spite of their popularity, each of the processes raise concerns as they are currently practiced.

Karl Fischer titration is one of the few assay techniques recognized by the US Food and Drug Administration for the determination of residual moisture in lyophilized pharmaceutical products (1). Because the iodine–water reaction is specific and quantitative, this technique provides high accuracy and precision.

Van Trieste is vice-president of quality at Amgen (Thousand Oaks, CA) and interim director of Rx-360, the recently established international pharmaceutical supply-chain consortium.

The contributions of classical chemistry to biotechnology are sometimes forgotten, and its advances are less recognized than those of recombinant DNA technology for the production of therapeutic proteins. The hard work of thousands of scientists and researchers in the solution chemistry of proteins has quietly supported the evolution of biotechnology.

It has been quite apparent to some of us in the pharmaceutical and medical-device industries that there appears to have been a directed effort over the past number of years to eliminate the concept of and need for the installation qualification (IQ) and the operational qualification (OQ).

The United States Pharmacopoeia (USP) has proposed revising the Labeling on Ferrules and Cap Overseals section of USP General Chapter <1> "Injections" to limit printing and other types of messaging on drug packages. The revision would limit printing to only cautionary statements on the top surface of the ferrule or cap overseal of an injectable drug product.