Steve Hammond, Pfizer director of Process Analytical Support, told an audience at the Association of American Pharmaceutical Scientists (AAPS) in San Diego the company spent five years and several million dollars creating production units that are transportable but also reliable.
He described Pfizer’s Advanced Process Control platform for producing tablets and capsules as combining wet granulation and direct compression machinery with quality control points.
The portable units “can be boxed up, put on a truck and brought anywhere,” he said.
“We can put together a manufacturing process anywhere we want in the world, validate the system, put in on a boat or helicopter or truck and ship it to wherever you want it to go.
Hammond called the strategy Pfizer’s “vision of manufacturing in the future” as it gives the flexibility to manufacture anywhere globally and still have a recoverable asset if market conditions change.
Lean and local
Two simultaneous changes in Pfizer’s global manufacturing strategy – the desire for lean, continuous manufacturing to limit distressed inventory, and a push to produce locally – brought about the project.
The local push came about when certain countries with very large markets “demanded, ‘If you want to sell it here you’d better make it here’,” said Hammond. In response, the pharma company has reversed its policy on plant locations.
“Pfizer ten years ago made the decision to coalesce its manufacturing into these giant centralised plants. It turned out to be entirely the wrong thing to do for the modern supply chain and now we’re undoing all that and thinking, how can we supply in local markets?”
But the large capital investment for production abroad raises the question, “how do you get that back if market conditions change again?” – a question answered by the pod system, said Hammond.
The company is also changing its policy on its billion-dollar inventory: “Distressed [wasted] inventory has to be a thing of the past. We have supply chain people demanding production is linked to demand for the product in the market.
The Advanced Process Control units were made in partnership with GEA and G-CONmanufacturing.
They include a wet granulation system fed by a continuous feeder and continuous mixer. From there, product enters a continuous dryer and a conditioning system (essentially a mill), on into more feeders and eventually to a tablet press.
Direct compression is simpler and involves a set of feeders.
The platform includes measurement controls at critical steps, and potential diversion points. It can be monitored remotely, in real-time for problems in production.
This analysis system is also a big part of continuous manufacturing, Hammond said: “We want to diagnose within minutes what the problem is, not spend weeks in retrospective investigation.
“In the end all of this has to fit the supply chain - you can’t get away from that. The analytical capability is there for a business reason – and that’s flexibility in the supply chain.”