Continuous processing still represents a major long-term aim for many pharmaceutical and biopharmaceutical producers. But until very recently, the process changes and validation required would have been so fundamental and onerous as to make it unachievable for all but the largest of companies. However, new market requirements along with regulatory and technology advancements are making small steps towards meeting this goal.
Recent technological progress in areas such as reactor chemistry, micro and nanoscale material processing, on-line monitoring and process control is bringing the reality of continuous processing a lot closer. The major regulatory authorities now acknowledge the benefits that continuous processing, aligned with initiatives such as process analytical technology and Quality by Design, could bring – i.e. greater process efficiency and control, better product quality and ultimately cheaper drugs.
Continuous processing is not necessarily going to suit every product and it cannot be implemented for all manufacturing steps without first solving issues around required volumes, quality, homogeneity and characterisation of intermediates
Continuous processing is not necessarily going to suit every product and it cannot be implemented for all manufacturing steps without first solving issues around required volumes, quality, homogeneity and characterisation of intermediates. Most of these issues will be specific to individual products. However, some companies are already en route. Eli Lilly, for example, is on the record as saying it has installed and demonstrated four different continuous processing platforms, with continuous processing steps in place for most of its medicines in development.
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