The expansions are centered on formulation development, analytics and clinical manufacturing to serve Phase III clients and those looking toward commercialization. The company’s integrated CMC (chemistry, manufacturing and controls) solutions, which are currently used by many of the top 20 pharma companies, will now be able to produce commercial APIs as well as capsules and tablets at batch sizes in the range of millions, which should be sufficient for Phase III and commercial purposes.
Aptuit is also adding lab scale nanomilling, hot melt extrusion, and spray drying capacity equipment including SEDDS/SMEDDS (Self-microemulsifying drug delivery system) technology.
The company’s solid-state chemistry and analytical functions across its Italy site will also benefit from XRPD (X-Ray Powder Diffraction), new surface area equipment and Z Potential/Dynamic Light Scattering as well as two new HPLC (high performance liquid chromatography) systems.
Johnathan Goldman, CEO of Aptuit, explained to Outsourcing-Pharma.com that the company is seeing a shift in industry where clients are beginning to prefer “this under-one-roof solution, rather than having to get API and drug product from multiple places” and companies.
“We didn’t choose to go into this market, it came to us via existing customers,” Goldman said, noting that customer demand was the driver of the expansions, which also added an unspecified number of new employees to the Italian facility.
“We have now received many requests to support programs to Phase III and beyond NDA (new drug application) 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,” he added.
Goldman also said the company is expecting to finalize “a couple of acquisitions” in the coming months, though confidentiality issues stopped him from elaborating more.