Canada-headquartered contract manufacturing company Patheon is now offering the largest capacity in Europe for Lyophilisation, following the completion of a €60 million investment programme at its facilities in Monza and Ferentino in Italy.
Lyophilisation, or freeze-drying, is a real money spinner for the contract manufacturing industry, and demand is expecting to increase significantly as more and more biological drugs come to the market.
"The quickest route to developing a biological for administration into humans is via lyophilisation," commented Jonathon Arnold, associate director, business management, at Patheon Italia. Freeze-drying of the protein or peptide-based drug keeps it in stable form until it is reconstituted just prior to administration.
Patheon got into the lyopphilisation business after acquiring the Monza facility in 1999. Anticipating that the growing number of biologicals coming through development would create a demand for these services, Patheon has added to this capability and now has 10 machines on-stream (mostly from BOC Edwards) - including five at Monza and a further five in Ferentino - for a total capacity of 272 square metres. It also offers a secondary packaging facility, and non-sterile lyophilisation services for laboratory-based developmental work prior to scale-up.
In an interview with In-Pharmatechnologist.com, Arnold noted that future developments at Patheon are also geared up towards providing manufacturing services for the biopharmaceutical industry.
Although lyophilisation is often the first presentation for a biological drug, lifecycle management often means that refinements in the process can lead to improvements in stability and, and potentially, the ability to supply it in liquid form that does not require reconstruction and is cheaper to manufacture. This has prompted Patheon to start developing capacities in sterile liquid small-volume potentials, sterile pre-filled syringes and sterile cartridges for use in pens/auto injector, said Arnold.
Another area for the future at Patheon is the development of solid dose manufacturing for high-potency drugs, including cytotoxic agents. There is significant under-capacity in this area, he noted, as handling of these drugs has been made more complex by recent regulatory developments. For example, they must be manufactured in fully-segregated facilities and can require high level health and safety measures, including in some cases the use of full 'space suit' protection for production staff. Development of these facilities can allow Patheon to work with unclassified molecules, is those whose properties are not fully established.
The company is currently looking specifically at developing its cytotoxic drug manufacturing, and is both looking at purchasing facilities or building one from scratch. Here, the main driver for such an investment is the biotechnology industry; many companies are developing drugs for cancer as it remains one of the most significant unmet needs in medicine.
Other new developments at Patheon include: an aseptic, large-volume parenteral plant at Fernitino, due to come on-stream in mid 2004 and with an annual capacity of 35 million 100ml vials; effervescent tab letting and a controlled-release technology based on coated beads that can encapsulated in hard shell capsules.