The pharmaceutical industry has for several decades been reliant on batch manufacturing, which dominated the blockbuster drug era. With profitability on the higher side, the need to innovate or consider new types of manufacturing wasn’t the need of the hour. Things began to change in the post-blockbuster era as companies realised material costs during drug development increased significantly, while new drugs were required to be produced in smaller quantities. Increased costs, longer production timelines coupled with inherent risks associated with batch processing led companies to look for an efficient and cost-effective process.
Continuous manufacturing had been in use across other industries but early adoption of this process in the pharma industry saw light only in 2015. In 2015, Orkambi became the first US FDA-approved drug to be produced via continuous manufacturing and later approved by the FDA. Subsequently, three more drugs made their way into the market following continuous manufacturing.
Slowly, the industry appeared to be catching up on continuous manufacturing for drug development. Continuous manufacturing helps uninterrupted production, manufacturing or processing of materials and enables faster product development, decreasing operational costs while providing increased flexibility in manufacturing. According to FDA experts and leaders, continuous manufacturing will have a positive impact on the quality of drug as margin of effort could be minimal with little intervention in production process. With continuous manufacturing, a drug produced in a month under batch processing might probably be produced in a day. Because the process is efficient and fast, it offers flexibility to produce drugs just-in-time based on market demand. This way companies would not need to worry about huge inventories to address surge in demand.
There are numerous players in the industry for which not all drugs developed would pass through clinical trial and successful production. As with any other change, transition to continuous manufacturing isn’t easy for the companies in this industry. A shift to a new manufacturing process involves huge investment and operational expenditure that could be unrealistic for a lot of companies, unless there’s a blockbuster drug with high market demand and requires continuous production.
In February 2019, the FDA issued a guidance ‘Quality Considerations for Continuous Manufacturing’, encouraging manufacturers to switch from batch to continuous production of drugs in order to improve consistency and mitigate the risk of shortage of drugs. The guidance indicates continuous manufacturing is recommended for solid oral drug products and small molecules and is certainly not applicable for biological products. Fast tracked drugs that undergo a quicker path to FDA approval and personalised medicine could be the trends to propel the need for continuous manufacturing, among other factors. Companies across industries are challenged to be flexible in manufacturing leveraging advanced technologies. Continuous manufacturing may probably not take over batch production as the de facto process in this industry, but it has the potential to play a bigger role in commercial manufacturing involving large-scale operations to meet changing market needs.