Diosynth Biotechnology

Diosynth Biotechnology Publications and Presentations

Fri, 08 Jan 2010 20:30:00 -0500

2009 PUBLICATIONS and PRESENTATIONS

Creation of a Well Characterized Small Scale Model for High-Throughput Process Development

Wed, 16 Dec 2009 16:00:00 -0500

Quality by Design in the CMO Environment

Mon, 10 Nov 2008 11:30:00 -0500

Incorporating quality by design into process development in a contract manufacturing environment can be challenging. In this case study, design of experiements was used to identify the key and critical operational parameters and their targets for hydrophobic interation chromatogaphy (HIC) used in the purification of an antibody. Six parameters that typically influence HIC performance were assessed for their effect on elution profile, product yield, and resolution between product and product-related impurities. Statistical software was used to design experiments and analyze the data. The data established wide ranges for some parameters and tighter controls were required for others that had a significant effect on product yield. Some of the parameters also influenced the elution profile and the resolution of product from product-related impurities. These bench-scale studies established a design space that delivered product with reproducible quality and yields during manufacturing.

Optimization of a PEGylation Reaction Using Design of Experiments (DOE)

Fri, 12 Sep 2008 10:40:00 -0400

The covalent attachment of polyethylene glycol (PEG) to a therapeutic protein is frequently used to increase the half-life of that protein in patients while reducing their immunogenic response. The PEGylation reaction can be optimized to maximize the desired product (average moles of PEG per mole of protein) molecules while limiting undesired byproducts (under- and over-PEGylated species). In the example discussed here, the desired molecule was mono-PEGylated, yet the preoptimized reaction yielded multi-PEGylated species visible by SDS-PAGE. The goal of our experiments was to maximize the amount of mono-PEGylated product produced during the PEGylation reaction while minimizing the costs associated with manufacturing the mono-PEGylated product.