Global challenges in pharmaceutical manufacturing
KATIE MURRAY
CPI, United Kingdom
Abstract
Advances in our understanding of disease mechanisms and our ability to make sophisticated molecules have resulted in an increase in targeted therapies. These are medicines that are highly effective in specific target population groups or are directed to a specific location in the body. However, targeted therapies are typically low-volume, high-complexity products and the current pharmaceutical supply chain is not agile enough to enable these therapies to realise their full potential to improve patients’ lives. To become more streamlined and cost-effective in meeting the supply chain needs for these products, the conservative pharmaceutical sector will need to overcome several challenges, including inefficient manufacturing and drug distribution. This can only be achieved by bringing together expertise from across industry, academia and government.
As scientists around the world make further advances in understanding complex disease pathways and developing enhanced drug delivery techniques, the way we think about medicines is beginning to change. Traditionally, drug formulations have been made with a one-size-fits-all approach that aims to have the greatest therapeutic effect across a broad swathe of the population. However, through the use of tailored drug formulations that are targeted towards specific population groups or specific sites in the body, physicians are able to treat patients more effectively. For example, stratified cancer treatments are designed to be highly effective in patients with a specific genetic mutation, and antibody-drug conjugates use a monoclonal antibody to direct a potent cytotoxic agent to a specific tumour site. We are far from realising the full potential of these approaches, however, because this enormous opportunity also presents significant supply chain challenges for the pharmaceutical sector. It will need to adapt, and quickly, to succeed in a world that is demanding small batches of targeted medicines at a reasonable cost.
Taking into account the number of drugs ...