Eden Biodesign is 2009 European Outsourcing Awards finalist
Category Shortlisted for: Best Analytical Contract Award
Project Title: Development and evaluation of Bio-Monoliths for the analysis of gene therapy vectors and other viruses
Company Name: Eden Biodesign Ltd, in collaboration with BIA Separations d.o.o
Successful development of biopharmaceuticals depends on high quality analytics to interpret process design and development studies. Of particular benefit are analytical methods that can be applied not only to final purified samples but throughout production. However, the analysis of large and complex biomolecules, such as viral particles, has long presented a challenge for process development and quality control.
Viruses such as adenoviruses are currently being evaluated for a wide range of clinical applications including gene therapy and vaccination. However, many conventional methods for quantitative analysis of adenoviruses are labour / time intensive and prone to error. As an alternative, high-performance liquid chromatography (HPLC) has been applied to analyse adenovirus preparations using various chromatography resins. The separation and analysis of large (macro) molecules such as virus particles using conventional packed bed porous chromatography resins is somewhat limited however because of steric restriction to the active binding sites.
By comparison, monoliths are homogenous columns with a continuous porous bed matrix, consisting of interconnected perfusion channels. These channels are relatively large compared to the typical pore sizes of packed-bed particle based chromatography. One benefit of this is that it increases the potential binding capacity of macromolecules such as adenoviruses.
BIA Separations (“BIA”; Slovenia) are market leaders in the development of a wide range of monolith chromatography supports based on CIM Convective Interaction Media® Technology, which among many other applications, is ideally suited for the separation of macromolecules. Previously developed columns, however, were not suitable for sensitive product analysis as they were not designed to withstand the high pressures of HPLC and required the application of relatively larger volumes of sample. BIA therefore developed a much smaller column (100 µL rather than 0.34 mL or 8 mL) that is housed in a stainless steel casing and thus is more suitable for the analysis of small sample volumes by HPLC.
A highly collaborative relationship was initiated between BIA and Eden Biodesign (“Eden”, United Kingdom) for method development and technology evaluation of the analytical bio-monoliths. Eden Biodesign are an expert contract provider of development and cGMP manufacturing services for new biopharmaceutical medicines, including novel gene therapies such as adenoviruses. Therefore BIA and Eden complimented each other perfectly in this situation: BIA had novel technology that required further development and evaluation in an applied setting, and Eden had the experience of manufacturing products such adenoviruses for clients, and needed improved methods by which to analyse these complex products.
The objectives were clear at the start: To develop and evaluate in an applied industrial setting the technology developed by BIA, with the aim of providing a method to enable rapid adenovirus analysis throughout the production process. The successful outcome of the project has been a fully evaluated technology / optimised methodology, with data that has been presented in numerous posters, oral presentations and peer-reviewed literature(1), and has provided real value to Eden&rsquos clients during numerous contract development / manufacturing projects. In addition, following this development programme the technology has been exclusively licensed for world-wide distribution by Agilent Technologies.
1: Whitfield RJ et al., Rapid high-performance liquid chromatographic analysis of adenovirus type 5 particles with a prototype anion-exchange analytical monolith column. J Chromatogr A. 2009