Offers manufacturing to Phase III and commercial scale
Aptuit, a global drug discovery and development contract research organisation, is investing in additional scale and capabilities. The company is increasing its 1,600L scale API capability at its plant in Italy, and has added a commercial GMP licence. The expansion is concentrated on formulation development, analytics and clinical manufacturing to serve Phase III and beyond.
The Greenwich, CT, US-headquartered company is also investing in lab scale nanomilling; hot melt extrusion, and spray drying equipment.
In addition, the company's solid-state chemistry and analytical functions will benefit from XRPD, new surface area equipment and Z Potential/Dynamic Light Scattering as well as two new HPLC systems.
The Phase II GMP production scale will increase to Phase III and commercial levels with additional shift cycles, capsuling machines, and a new pan-coating machine.
We have received many requests to support programmes to Phase III and beyond NDA filing to product launch
Aptuit's Chief Executive Jonathan Goldman said: 'Customers have noted our unique single source high quality fully integrated solution for API and drug product up to Phase II scale. They wish to maintain consistency of scientific excellence, and avoid risk of technology transfer at a critical phase in product development. We have now received many requests to support programmes to Phase III and beyond NDA filing to product launch.
'The expansion of capacity, numerous capital investments and adding a GMP licence is part of our strategy to leverage our core competency of integrated early Phase CMC to fully integrated CMC at commercial scale. We will deliver these services from our fully integrated CMC facilities in Verona, Italy, and Oxford, UK.'
Goldman added that Aptuit will now be able to produce up to commercial API, as well as capsules and tablets at batch sizes of millions, which will be sufficient for Phase III and commercial purposes.