Production of Hyaluronidase by .

Hyaluronidases have been a subject of great interest in medical and cosmeceutical applications. Previously, our group demonstrated that the venom glands of contain hyaluronidase enzymes (VesT2s), and heterologous expression of the corresponding gene () in systems results in inclusion bodies, necessitating functional folding using urea. Here, we report the successful heterologous expression of VesT2a in the expression system, with gene construction achieved using Golden.

From natural to synthetic: Promoter engineering in yeast expression systems.

Synthetic promoters are particularly relevant for application not only in yeast expression systems designed for high-level heterologous protein production but also in other applications such as metabolic engineering, cell biological research, and stage-specific gene expression control. By designing synthetic promoters, researcher can create customized expression systems tailored to specific needs, whether it is maximizing protein production or precisely controlling gene expression at different stages of a process. While recognizing the limitations of endogenous promoters, they also provide important information needed to design synthetic promoters.

Closed System Transfer Devices (CSTDs): Understanding Potential Over- and Under- Dosing of Liquid Vial Drug Products and How to Generally Mitigate.

Closed system transfer devices (CSTDs) are a major challenge for drug manufacturers to assess and assure drug compatibility and acceptable dosing accuracy for a range of clinical administration strategies. In this article, we systematically investigate parameters affecting the loss of product during transfer by CSTDs from vials to infusion bags. We show that liquid volume loss increases with vial size, vial neck diameter, and solution viscosity - while dependent on stopper design.

An Intra-Company Analysis of Inherent Particles in Biologicals Shapes the Protein Particle Mitigation Strategy Across Development Stages.

To better understand protein aggregation and inherent particle formation in the biologics pipeline at Novartis, a cross-functional team collected and analyzed historical protein particle issues. Inherent particle occurrences from the past 10 years were systematically captured in a protein particle database. Where the root cause was identified, a number of product attributes (such as development stage, process step, or protein format) were trended.

Tolerance Interval Approach for the Determination of Overfill of Liquid Parenteral Drug Products.

Liquid parenteral products contain an overfill to ensure withdrawal of the declared volume. The overfill must be sufficiently high to compensate for the expected loss during product preparation and administration, but it should also be minimized to prevent accidental overdosing and unforeseen dose splitting of single-dose products. Finding the right balance between too much and too little overfill with an acceptable risk of product failure is challenging and requires consideration of the relevant sources of variability of the extractable volume.