Aptuit Expands Scale of Drug Product CapabilitiesBy
Aptuit LLC has augmented its existing 1600-L scale active pharmaceutical ingredient (API) capability and commercial GMP API license with investments in scale and capabilities in drug product development and manufacturing, including formulation development, analytics, and clinical manufacturing,to serve Phase III and beyond as well as commercial GMP licenses for drug products. Aptuit will now be able to produce commercial APIs as well as capsules and tablets at batch sizes in the range of millions, sufficient for Phase III and commercial purposes.
Aptuit's existing expertise in bioenhancement is further strengthened with additional lab-scale nanomilling and 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 II GMP production scale will increase to Phase III and commercial levels with additional shift cycles, capsuling machines, and a new pan-coating machine.