The industry is looking forward to the next frontier, with regulators generally approving continuous manufacturing of biologics. In 2021, guidelines for the continuous manufacturing of biologics will be issued by the International Council for Harmonization of Technical Specifications for Pharmaceuticals for Human Use (ICH). To date, the FDA has approved continuous manufacturing of innovative products (Table 1), all small molecules, for six final doses. Approximately 50 other national regulators have given at least one such approval, indicating that this methodology, at least for small molecules, has earned worldwide acceptance.

In order to accommodate continuous production, some regulations still need to be modernized and, in turn, ICH will need to harmonize these standards among national regulators, said Moore, who previously worked for the FDA and Pfizer (New York, NY, US). New products will be the majority of the products that are likely to be manufactured in integrated continuous lines, and will also be mainly labile biologics or those that have unknown demand. Investors and industry insiders should track company patent filings and peer-review papers written by company executives to tell which pharmaceutical manufacturers are likely to incorporate end-to-end continuous manufacturing into production lines first. 

For some time, regulators and some pharmaceutical firms have touted the benefits of continuous manufacturing. A smaller equipment footprint can be created by the process because the equipment is used for longer without breaks between batches. By running the same equipment for longer, it often usually achieves greater amounts.

If there is an issue during development, manufacturers need to decide what to do, so they can segregate potentially non-conforming products from the rest of the process. In addition, depending on the dosage type and the corresponding method, continuous manufacturing involves various control strategies. Continuous manufacturing approvals have so far been made for small molecule, solid oral dose products, with powder flow-related processing steps. Various measuring techniques would be needed for a liquid drug, which has diffusion measures.

For some time, regulators and some pharmaceutical firms have touted the benefits of continuous manufacturing. A smaller equipment footprint can be created by the process because the equipment is used for longer without breaks between batches. By running the same equipment for longer, it often usually achieves greater amounts.