This is Part 3 of a 3-Part series detailing a product’s pathway from research & development (R&D) to clinical trials to manufacturing.
Of the many thousands of drugs that are synthesized in the R&D stage of drug development, only a small percentage, 1 in in 5,000, will successfully pass through clinical trials and FDA approval, and on to manufacturing. (1) The manufacturing process is multi-layered and complex; having an understanding of the process and which method is right for your drug and company will preserve both money and time. In the final installment of this series, we analyze the two major manufacturing processes and help you assess which will be a better option for your drug.
Batch processing represents the history of pharmaceutical manufacturing, and possibly the past, as continuous processing (described below) is increasing in popularity among pharmaceutical corporations.
Drugs produced by batch processing are typically only required in small amounts, and are completed through multiple (and oftentimes disconnected) batch steps; said steps frequently occur at different locations. Major advantages of batch processing, particularly in comparison to other processing methods, are the low factory equipment costs and widespread expertise of professionals who use this method. Alternatively, batch processing confers multiple disadvantages, such as a slow rate of production, frequent shut-down times, and difficult automation. (2)
Developed in 2012 through a partnership between MIT researchers and Novartis, continuous manufacturing has potential as the future of drug manufacturing. Compared to the traditional manufacturing process, continuous manufacturing occurs at a single facility; this allows for a faster process and lower long-term manufacturing costs.
In terms of the process itself, continuous manufacturing utilizes tubes that reactants flow through and undergo chemical reactions within. If a specific drug’s process entails multiple steps, reagents can be easily added to the flow where needed. Additionally, when heating and cooling need to take place, the flow system can more efficiently acclimate to temperature change than the large vat used in traditional manufacturing. Finally, quality control under a continuous system is much more streamlined. Because drugs are being produced at a single location, continuous monitoring can occur, which lends to overall higher drug quality.
Transitioning to a different manufacturing process may require some drug companies to re-request FDA approval, and of course, purchase the required equipment. Particularly in continuous processing, initial costs may feel excessive. However, researchers and pharmaceutical companies are encouraged to look at the long-term cost-benefit; initial estimates indicate 15-50% long-term savings with continuous processing. (3)
Regardless of which processing method is the best fit for your laboratory, your drug will need to prove its value in both safety and effectiveness to even get to the manufacturing stage of drug development; this can be accomplished by utilizing high quality equipment in the R&D phase, and again in the manufacturing phase.
BEEI International produces homogenizers that can yield a variety of relevant products, such as emulsions, suspensions, dispersions and lipids. Importantly, these products go on to make up the injectables, inhalants, anesthetics, and vaccinations that attain FDA approval for manufacturing. In addition, BEEI has extensive experience assisting its product users as they transition through the drug development process.
Visit BEEI here to learn more about how their homogenizers can optimize your drug’s chances of success.
We hope that this series makes you feel more equipped to push your innovative drug through the development process. Check out Part I for more on R&D, and Part 2 for a breakdown of the clinical trial process.