Aptuit LLC has announced that it has augmented existing 1600L scale API capability and commercial GMP API license with numerous investments in scale and capability in Drug Product. These include Formulation Development, Analytics and Clinical Manufacturing to serve Phase 3 and beyond as well as a commercial GMP license for Drug Product.
Aptuit’s existing expertise in bioenhancement is further strengthened with additional lab scale nanomilling; hot melt extrusion, and spray drying equipment including SEDDS/SMEDDS technology. 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 HPLCs. The Phase 2 GMP production scale will increase to Phase 3 and commercial levels with additional shift cycles, capsuling machines, and a new pan-coating machine.
Dr. Goldman stated: “Customers have noted our unique single source high quality fully integrated solution for API and drug product up to Phase 2 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 programs to Phase 3 and beyond NDA filing to product launch. The expansion of capacity, numerous capital investments and adding GMP license 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.”
Dr. Goldman explained that Aptuit’s integrated CMC solution will now be able to produce up to commercial API as well as capsules and tablets at batch sizes in the range of millions, sufficient for Phase 3 and commercial purposes.
“Our company is experiencing significantly increased demand due to outstanding scientific excellence and unique ability to fully integrate CMC. We are delighted to respond with a high quality solution by expanding capacity and capability.”
Dr. Goldman concluded, “We are focused on helping customers discover, develop and produce drugs with very high quality, whilst minimizing operational risks. Our existing integrated CMC solution is now enhanced to commercial Phase and remains best in class for scientific quality, speed and cost.”