In the pharmaceutical industry, both branded and generic drug manufacturers could improve speed to market by adopting a continuous process development and manufacturing approach. Process Analytical Technology (PAT) allows pharmaceutical producers to evolve from a batch production process to a continuous one. It therefore represents a key enabling technology that can lead to a better supply of affordable, safe and quality assured medicines worldwide.
Martin Gadsby, Director at Optimal Industrial Technologies, looks at how PAT can improve global health by speeding up the development and production of new and existing drugs. Reducing production costs, improving the consistency of quality and allowing improved access to affordable medicines, especially in developing countries.
The pharmaceutical industry is often driven by discovery of new molecular or chemical entities, i.e. drugs, that can be patented. Once patented, licensed and launched on to the market, there is a commercial imperative to cover development costs and make profits. However, the cost of product development is increasing, becoming more challenging and at an ever-higher commercial risk factor, so an offset is sorely needed.
Improving patent life coverage by reducing development time
Patents work as an incentive to keep pharmaceutical manufacturers coming up with new products, as they allow the innovator or manufacturer a period to recoup expenditure on drug development and trial costs. Nonetheless, the life of a patent is finite, and generally more than half of the patent life of a new drug is lost in the development stage, before the product has even been launched.
By shortening the development and scale-up time of a new large or small molecule candidate, it is possible to substantially reduce the time taken to bring a new drug to the market and gain months or years of additional time covered by the patent. For many processes this can be achieved by shifting from batch to continuous processing.
By adopting this approach, it is possible for the development system to be in exactly the same format as the full manufacturing one, eliminating a large proportion of the time taken for scale-up. Also, time and material costs associated with Design of Experiments (DoE) are considerably reduced.
In addition, it empowers manufacturers to have a holistic, end to end, real time quality assurance built into the process. This can help facilitate Real Time Release Testing (RTRT). Consequently, quality testing efforts, manufacturing time and costs are substantially reduced, whilst also improving product quality.
As such, process analytical technology (PAT) is a gateway that allows this change in manufacturing practice. The data generated by spectral instruments and univariate analyses on production equipment feed into multivariate prediction models that have the capability to provide real-time quality predictions, assuring product quality at every stage of the production process.
Reducing drug production time and cost
Once a drug is no longer patented, PAT can also be used to deliver cost, productivity and quality advantages when manufacturing quality-compliant generic drugs. While the latter are generally sold at a lower price than the branded equivalent, PAT can still be used to improve an existing batch process, or, even better introduce a continuous process that can be used for multiple stock keeping units (SKUs).
Therefore, the manufacturers of generics can benefit from savings such as shorter production cycle times, higher productivity and asset utilisation. Lower levels of waste and off-spec material are produced, work in progress is reduced and energy consumption cut. A smaller production footprint is required as well as reduced overhead for quality testing, and potentially lower regulatory oversight.
Optimised worldwide access to medicaments
Eventually, greater efficiency for manufacturers of branded or generic drugs will positively impact global health. PAT-led drug production ultimately benefits patients worldwide, particularly those with limited access to medicines.
At least one third of the world’s population (approximately 2 billion people) has no regular access to medicines.1 Two of the main reasons for the lack of access to essential medicines are their prohibitive prices and limited availability. These issues have a particularly strong impact on developing countries, with the result that diseases prevalent in these areas are largely neglected. Furthermore, fake or sub-standard drugs are more of a concern in poor countries, with one in 10 medicines in developing countries reported as being counterfeit.2
Continuous manufacturing in pharmaceutical production can optimise availability and affordability for essential quality-controlled medicines. By simultaneously lowering the development and production costs while reducing time-to-market for new drugs, PAT allows pharmaceutical industries to increase the availability of both patented and generic medicines.
In addition, by speeding up the production cycle while ensuring real-time product quality during manufacture, PAT-led production can improve the global medicine supply system, helping with the prompt response to epidemics and outbreaks.
Furthermore, by increasing the efficiency of the overall production cycle for new medicines, PAT makes it easier for pharmaceutical companies to develop new drugs for the treatment of neglected, rare or emerging diseases, thus improving people’s quality of life and life expectancy.
The rise of continuous manufacturing
As an example, companies that have already benefitted from deploying PAT include Vertex Pharmaceuticals. Patricia Hurter, PhD, Senior Vice President, Pharmaceutical and Preclinical Sciences Vertex comments on continuous manufacturing (CM).
“Vertex has made a strong commitment to continuous manufacturing, and to mitigate risk as we embarked upon this ambitious project, we made the decision to bring multiple facilities online to manufacture our medicines, including facilities that are fully continuous (Boston, MA) and other facilities globally that reflect both a CM and hybrid approach, ensuring a robust supply chain network for our manufacturing efforts.
“Once a few companies have demonstrated that the perceived regulatory and technological hurdles of implementing this technology are not standing in the way of success by receiving approval for commercial products, we think this will reduce the risk substantially for others, and then the benefits of CM will be such that anyone not adopting this technology may be at a sufficient disadvantage.” 3
Tangible results
Vertex uses the PAT based production and development management software platform synTQ developed by Optimal Industrial Technologies. This is currently in use by over half of the global pharmaceutical manufacturing majors. Its success has been proved worldwide, with some users reporting how production cycle times have been reduced from weeks to hours with corresponding vastly improved productivity levels.
PAT holds a lot of promise for the future in pharmaceutical development and manufacturing, as it provides a key to encouraging medical research and protecting profits – while at the same time keeping medical treatments affordable and accessible. Through the continued development of platforms like synTQ, it is possible to further drive efficiency into current drug production lines and expand global health access.
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