The CURE BioHaven meeting on 12th May gave voice to an innovative on-site manufacturing method that is designed for multiple products, rapid changeovers and flexible, batch-sized production-on-demand technology. The idea of manufacturing in pods promises to transform pharmaceutical development, manufacturing and distribution in general. It also anticipates overcoming the challenges currently faced by a processing based industry and speaks to the globalization of the pharmaceutical market.
PCM&M, the simplified way of saying “Portable, Continuous, Miniature and Modular Manufacturing” seeks to maintain a balance between speed, cost and quality of the manufacturing process. The portable and modular aspects in design and the precision engineering in the unit design warranties assembly within 3-4 days. The basic concept behind this move to such innovative design is to use the same equipment for development as well as manufacturing, hence avoid the burden associated with technology transfer— process chemists and engineers having to learn and then transfer what works and doesn’t work as drug product scale-up and production moves along the development path. The modular design will reduce inventory pressure as someday it can be used for the production of API’s on-demand and the continuous process will ensure consistency. Further, it overcomes large local labor costs since once installed only three direct operators would be needed to produce millions of capsules in short order and at any given warehouse location world-wide.
Michael O’Brien, VP Technology & Innovation at PTx Pharmaceutical Sciences, Pfizer enthusiastically said that they have created something flexible and practical that will cope with the challenges of building facilities and manufacturing drug product on demand in each country where a drug is sold. The design allows pods to reuse warehouses and existing structures, speeding the overall deployment of new products, saving costs and time. He further explained that, although their design is patented, Pfizer has implemented an open innovation model, and as such they seek many multiple partners to access the technology and improve it so that this approach to manufacturing is optimized by many, rapidly.
The PCM&M strategy implies cost savings in technology transfer time and knowledge loss, costs for out of date drug material storage and new avenues for new process chemistry intellectual property identification. As this new idea of profitable design is implemented by Pfizer and other companies, savings can now be used in the design of new and improved drugs.
Looks like, in the pharmaceutical industry, production and distribution from the point of manufacturing is the future!
You can access Mike O’Brien’s presentation here.