When developing and producing drug delivery components and devices, the pharmaceutical industry has a conservative reputation and is known to be a slow adopter. Manufacturing Chemist spoke to Michael Sivigny, Manufacturing Administration at 3M, to discuss both hurdles to progress and how to overcome them
MC: What do you see as the greatest factor inhibiting the pharma industry’s investment in newer technologies?
MS: Ironically, the existence of “old” technologies inhibits the adoption of new ones because of the high level of resources required during the transition period from old to new. The resources used to implement new systems are often the same as those required to maintain legacy systems. And, although this is true for most industries, the requirement for both systems to operate in a highly validated state makes this especially resource-intensive for pharma companies.
The implementation of a new technology that is not supported by the equipment supplier in the long-term is, essentially, a kiss of death for manufacturers. Every system used in drug or device production manufacturing must be fully vendor supported for ongoing maintenance and software upgrades. This is why pharmaceutical firms will always be late adopters, as new technology vendors must demonstrate long-term viability from both a business and technical perspective to warrant serious consideration.
As in any other business, capital investment in pharmaceutical companies requires financial justification. However, additional costs related to product stability testing and regulatory approvals often exceed the equipment cost itself, making the financial justification difficult. As product testing and regulatory filing costs cannot be capitalised, these expenses are incurred in real-time and, typically, are not recaptured in the product unit cost.
MC: Regulators such as FDA say they are committed to changing the picture and encouraging the use of better, more innovative manufacturing methods. Do you see this happening and, if so, can you give some examples?
MS: Process Analytical Technology (PAT) guidelines are a step in the right direction. It’s encouraging to see FDA working to reduce pharma manufacturers’ “technology adoption anxiety” by establishing PAT inspection teams, offering preoperational reviews of PAT manufacturing facilities and providing feedback regarding potential regulatory pathways via the submission of comparability protocols. This framework enables pharmaceutical companies to hedge their bets on new technology before fully committing to implementation.
MC: How has your company and its collaborators responded to the challenge of using better manufacturing methods while keeping costs down and still remaining compliant?
MS: 3M is a diversified manufacturer that constantly harnesses know-how from 46 core technology platforms to stay competitive. These are “owned” by the 3M Corporate Research Laboratory and their mission is to support 3M Divisions in any way possible. As a pharma manufacturing engineer, this means that I have a host of subject matter experts who are readily available to discuss with me how a new technology may benefit a specific application. In many cases, the new technology has already been proven to be successful in a non-pharmaceutical 3M business, thereby eliminating the uncertainty of how the new system will fare in a production environment.
Automated optical inspection, clean-in-place functionalities, high speed converting, SAP and Customer Managed Inventory are just a few examples of manufacturing methods presently employed in 3M Drug Delivery Systems that were first implemented somewhere else at 3M.