Local vs Global Manufacturing
Ramesh Subramanian, Ph.D. VP, Strategic Marketing and Global
Head, Business Development, Piramal Discovery Solutions
A: Supply chain has always been the backbone of the global pharma-ceutical industry and all firms strive to ensure on-time delivery of drugs. New product approvals, pandemic threats, low-dose drugs, multiple dosage forms, uncertain market demand and geographic spread are driving the demand for customized manufacturing and supply solutions. Focus has now shifted from large-volume drugs to low-volume highly potent drugs treating rare and orphan diseases. To be able to cater to specific requirements, manufacturers must implement lean, adaptable facilities that can switch quickly between multiple products in multiple dosage forms. Criteria to be considered while designing a manufacturing facility include adequate space for orderly placement of equipment and materials to prevent mix-ups and contamination as well as suitable size, construction and location to facilitate cleaning, maintenance and proper operations. Above all, proper adherence to GMP regulations must be kept in mind even before designing and engineering the pharmaceutical manufacturing facilities to be approved as compliant — this is in the best interest of manufacturers to avoid approval delays with local authorities in regions where they intend to market their drug products.
William J. Monteith, Chief Operating Officer, PCT
A: I think that one of the biggest factors impacting facility and equipment design is the regulatory need to assure that the product can be produced the same at every location, cost-effectively. For that reason, the cell therapy industry is evolving towards modular design of facilities for maximum flexibility while still providing design consistency, automated processes to reduce operator error and minimize process variability, and — in the case of sterile manufacture — closed-system processing.
Note: Answered in terms of cell therapy manufacturing, not pharmaceuticals.
Stefan Peterli, Ph.D., Vice President of Strategic Business
Development, Minafin S.P.R.L.
A: The Minakem GMP factories provide drug substance according to client specifications in the case of custom manufacturing contracts, or in the case of generic APIs according to pharmacopeia standards (e.g., EP or USP). API delivered with appropriate certficiation (e.g., a CEP) gives the client the certainty that the API has been produced according to international standards as defined by the ICH Q7 guideline. While the Minakem group is not currently producing drug product, it certainly recognizes the need for local drug-product manufacturing in factories adjusted to local market size. Such local factories are, in certain countries, mandated by the local government to be allowed to sell drugs in that country. They should, however, always be at the highest quality and compliance standards.
Justin Schroeder, Executive Director of Marketing, Business
Development & Design, PCI Pharma Services
A: We see the biggest impact coming from the requirements of individual country regulatory agencies. For example, requirements brought forth by countries such as Turkey or Brazil may not necessarily be areas of focus for the FDA or MHRA/EMEA. These specific export country regulatory requirements can considerably affect workflows, infrastructure and operational design for our sites. Being a supplier to so many countries, we have to ensure our operations are compliant for the many markets for which our products are destined.