Scientific activities in the post-genomics area are extensively focused on identifying and characterising candidate molecules with the potential to benefit and improve the lives of the world´s populations. Over the next few years, effective manufacturing strategies will be required to meet the rigorous demands of making these important scientific advances rapidly available.

At present companies have various degrees of enabling know-how, technologies and resources; however, the number of candidates may likely outstrip the currently available contract manufacturing resources and technologies for process development activities as well as manufacturing. To effect critical time to market, companies will need to consider their process development strategies early in the drug development cycle, taking the investment risk of increasing their own capacity and resource base or alternatively limiting that risk by outsourcing.

Molecular Biology

No single promoter, expression vector or process can be utilised for the high level expression of every protein - as yet there is no set of well-characterized "rules" governing a decision as to which expression system would deliver the highest yield of any given protein. more

Fermentation

Development of a reproducible and productive fermentation process is one of the key stages for the effective manufacture of a recombinant protein. Organisms used in the production of recombinant products are complex and respond to changes in the environment. more

Downstream Processing

An effective DSP strategy is critical to delivering product to market of an appropriate quality and acceptable cost. more

Biossays

Bioassays are one of the few analytical tools where native proteins can be characterized in vitro, under physiological conditions. They are essential in assuring integrity and functionality of a biological product. more

Analytics

The production of therapeutic proteins for use in clinical applications is stringent and rigorously controlled. The burden of proof lies with the manufacturer, who must be able to demonstrate, using robust analytical procedures, the quality and consistency of the product and process. more

Documentation

Communication and information exchange as a project progresses is fundamental to attaining objectives in an efficient and timely manner. An organised documentation structure and maintenance of that structure is essential. more