This (1) is an interesting report of spending tax payer (over billion dollars) and company money with no return. Perspective presented is mine and not influenced by any "for or none profit entity".
Goals are noble but the pathway is very prickly and difficult as it has been spun many times in the last 10 plus years with no results.
Companies who need to innovate their processes and technologies do it themselves as we all have been taught the fundamentals of chemistry, chemical engineering and their applications. If we cannot then we have an issue with our teaching and practice methods.
FDA's suggestion of advanced manufacturing technologies suggested ELEVEN YEARS ago has gone nowhere. New names have been given to the same dance.
REAL continuous manufacturing has been taught (nonstop) i.e. raw materials in and product out and practiced for over 80 or more years and pharma has avoided considering it. It needs to revisit as creativity and imagination is needed. It has been done successfully in fine/specialty chemicals, older cousin of pharmaceuticals (active ingredients and their formulations. Pharmaceuticals are still stuck at "B" (batch) and to move to the adjoining letter "C" (continuous) totally different landscape and methods are needed. We need to "THINK DIFFERENTLY".
Like other projects "Equip-A-Pharma" will also be a failure. Why? Companies have to have a need for the technologies for their products. No need no project and monies get squandered. Products need different tunes to dance. It cannot be the same tune and different dances. It will go nowhere, my conjecture.
HHS comment "Traditional pharmaceutical manufacturing is often too rigid and slow to adapt to changing demands". There is reason as its affiliate FDA has never been on the same page. Again companies have to write their own music and lyrics.
Battelle Memorial Institute and Aprecia; BrightPath Laboratories; Rutgers University; and the Mark Cuban Cost Plus Drug Company have chased and are chasing a dream on someone else's dollar. It is easy to go that route.
Lastly artificial intelligence (AI) is the supposedly the answer but its actual ignorance (AI) of reality is an issue and comes in the way.
We have the knowledge and desire to excel but if we are going to sing 60 year old music today, not many will listen. Observations are welcome.
Girish Malhotra, PE
EPCOT International
Reference:
Advanced Mfg. in Pharma: Where Does It Play? September 18, 2025
