Enhancing efficiency and economics in process development and biotherapeutics

COST CONSIDERATIONS and lengthy development times for biotherapeutics have necessitated enhanced process efficiencies at all stages of drug discovery and development. Increasingly stringent regulatory requirements targeting better understanding and control of manufacturing processes are expected to positively impact product quality and performance. Quality, which begins with the determination and characterisation of critical quality attributes (CQAs) for any new biotherapeutic, is a critical step in ensuring product efficacy and safety. Once these attributes are determined, they become key parameters for assessing the quality of the product throughout its life cycle – particularly prior to commercial release and subsequent in-process testing and lot release. While a CQA should technically be dependent on the biotherapeutic in question and needs to be established specifically for the lead molecule during development, some key attributes are known to be common for most platforms. These include product specificity to target, titer, product activity or potency, cell-line inherent contaminants such as host cell proteins, and propensity to aggregation among others. The need to rapidly assess these quality attributes in a cost-effective manner therefore fuels the search for innovative analytical techniques that can provide improved performance and speed without increasing costs.

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