By Jerry Martin, pharmaceutical and life sciences consultant, PMMI, The Association for Packaging and Processing Technologies
For many drug manufacturers it can be a challenge to determine whether a path to continuous manufacturing is right for them. Continuous manufacturing can offer more efficient production, lower cost, consistent quality of product and improved safety during processing. However, batch production can still be the way forward for drugs needed in low volumes or requiring degrees of patient customization.
Here are a few points to consider when weighing the pros and cons of each manufacturing type.
- Drug Type
Continuous manufacturing is still in its infancy within the pharmaceutical industry, but stands to improve the overall quality of biotherapies. Early adopters of continuous manufacturing are likely to be the manufacturers of APIs, bulk formulations and dry powders used in solid dosage pharmaceuticals because conversion is relatively easy in these areas. Meanwhile, adoption of continuous manufacturing is still a long way off for biopharmaceutical processing of monoclonal antibody and recombinant protein drugs, because these drugs are deeply entrenched in the batch methods and current technology.
- The Cost of Adoption
It goes without saying that large-volume producers of bulk formulations and dry powders may see and capitalize on the long-term cost reduction benefits associated with continuous manufacturing because the path to conversion is less complicated and more cost-efficient. However, companies that deal in low-margin drugs or small-volume batches are less likely to experience those cost-savings in the short-term and, ergo more likely to stick with existing batch processes and technologies…for now.
- Due Diligence
Currently, the Food and Drug Administration’s (FDA) flexible definition of “continuous” may make it easier for companies to test the waters. While the FDA is an influential proponent of continuous manufacturing, many drug companies are seeking more detailed guidance from the agency on how to make the switch. In the meantime, manufacturers should do their own due diligence to ensure compliance while minimizing associated costs and potential downtime.\
- Integration of Single-use Systems
The trend toward continuous manufacturing complements the increasingly popular adoption of single-use process equipment, especially in biotherapy production. Manufacturers are attempting to integrate single-use systems into a continuous production platform. The areas most likely to see a convergence of these two processes are bioreactors, chromatography and filling operations.
Pharmaceutical professionals can learn more about continuous manufacturing solutions at Healthcare Packaging EXPO. Register for the show at www.hcpelasvegas.com.
About Jerry Martin
Jerry Martin is an independent consultant to pharmaceutical manufacturers and equipment suppliers for filtration, single use manufacturing, marketing, business development and regulatory compliance. He was previously Sr. Vice President, Marketing and Global Scientific Affairs for Pall Life Sciences where he served the pharmaceutical, biotech, medical device and vaccine industries for over 37 years. He is currently chairman emeritus of the Bio-Process Systems Alliance, the single-use manufacturing trade association and a member of the USP Expert Panel on Plastic Systems Used for Manufacturing Pharmaceutical Products. He holds a M.Sc. in Microbiology from the University of Toronto.