Manufacturing & Analytical Characterization
Paul Wan Sia Heng, PhD (he/him/his)
Honarary Fellow
National University of Singapore
Singapore, Singapore
Bhavishya Mittal, PhD (he/him/his)
Vice President
BioDuro
Irvine, California
It is well-known that the pharmaceutical industry is generally conservative, slow to change in its highly regulated operational space. Nevertheless, pharmaceutical companies are continuously seeking manufacturing processes that are more reliable and efficient, faster turnaround and lower production unit cost. Innovations have always been pursued in the pharmaceutical industry, particularly in the search of new drugs and delivery methods, to treat certain maladies, enhance efficacy, patient acceptance and commercial benefits. For off-patent drugs, increased competition drives innovations towards lowering production unit cost while maintaining or enhancing consumer acceptance. The last notable pharmaceutical manufacturing advancement is continuous manufacturing, over a decade ago and now; more products are being produced by continuous manufacturing. Innovations in continuous direct tableting, end product testing and containment have evolved. Fluidised bed applications in granulation and coating have innovated to improve efficiency and better process control. For inhalation technologies, improved blending and dosing have advanced efficiency. Future innovations in oral solids and inhaled products manufacture will be incremental, by adaptive innovations, for better efficiency or process control. Lower cost can be achieved through high volume end-to-end manufacturing, from synthesis to finished product. However, considerations of potential supply chain disruptions will limit the monopolistic market.