Increasingly, drugs made in one part of the world are sold in another, making stability a key concern for pharmaceutical firms. While lyophilisation is not a new approach to the problem, its cost and complexity had meant that global capacity was limited.
In recent years however a number of contract manufacturing organisations (CMO), including Patheon, Recipharm, HollisterStier and Clairvest, have been investing in lyophilisation capacity in a bid to address the imbalance.
Formatech business director Jeffrey Bernard also believes activation of the good manufacturing practice (GMP) standard lyophilizer, the second to be installed at the plant, is a timely move.
He said that: “Given the cash burn rate of the typical emerging biotech or pharmaceutical company, a delay in production by even a week due to production capacity constraints may cost a client hundreds of thousands of dollars.
“By doubling our capacity for processing lyophilized products, we have reduced the bottleneck, can better meet our clients scheduling needs and most importantly get them to the clinic on time,” added Bernard.
Installation and validation work on the new lyophilizer was completed in December, as was the Food and Drug Administration (FDA) GMP inspection.
Formatech stressed that, aside from the capacity boost, Formatech the similarity of the new lyophilizer to its existing FTS system is another key benefit as it improves the efficiency of its technician training programme and will reduce errors.
The firm went on to explain that interchangability of parts between the two units, and the timeline flexibility that this allows, had also played a major role in selection of the unit.