Ampac claims revolution in continuous processing

Following launch at a symposium in Boston in September, Ampac Fine Chemicals (AFC), an SK Pharmteco company, has announced the development of a new series of skid-based modules for continuous flow processes. These, it claims, will revolutionise the technique, closing the gap between benchtop development with microreactors and manufacturing scale.

Both AFC and SK Biotek have been active in continuous processing for many years in areas such as cryogenics, oxidation and SMB chromatography, but almost always at large volume scales. Historically, it has been difficult to implement at small scale and during the early stages of drug development, when pharma companies want to get their clinical material in quickly, regardless of what the best or cheapest process is.

Each of the modular units is fully qualified and can be stacked on top of each other and connected up, delivering the exact process conditions the chemistry requires, said Bill DuBay, VP of global R&D. Thus the cart can be built up for specific reactions, work-up, separation or distillation, with the process built piece-wise into it. They units – as yet, they have no brand name - can typically produce 5-20 kg/day of API for clinical phase programmes, much faster than batch processes.

All of them are of the same height, width and depth, DuBay added. “Once you are done, you clean the unit operation, take them apart and reassemble them to go into the next process.”

Each module has its own interface, with an input-output plug that goes directly into the cart. The built-in computer can recognise which building block it is and the order it is in, so that the whole set-up can be operated manually based on in-house developed software. The whole skid can fit within the space of a kilo lab.

The carts can be reconfigured in a matter of days once each of the modules are built. It takes weeks to put together a new or different module but once available it can be readily reconfigured as multi- product equipment, DuBay said. This means lower capex costs and avoiding the problem of the long lead times required to build dedicated skids, which has also often hindered the adoption of continuous processing in the early stages. Scale-up for production in dedicated continuous units is said to be straightforward and inexpensive.

According to Dubay, the concept is unique to AFC among CDMOs, though some Big Pharma companies, notably Eli Lilly and Novartis, have developed similar ones within specific projects. The company is currently carrying out a demonstration project with a four-step process for an unnamed API within three kilo lab hoods at its site in Rancho Cordova, California. It is also now working out what the opex savings are relative to the same process in batch.

Plans are to move the process, once ready, to its other site in Virginia and run them with its partner Phlow, a public benefit corporation focused on essential medicines. “We will continue to build up our library of modules as we develop other APIs,” said DuBay. “We are also looking at scaling the carts up or out as we move to a bigger scale.”