DPT’s $30m sterile unit investment
First up are US contract development and manufacturing organisation (CDMO) DPT, which provided more details on the new sterile and specialty product manufacturing facility it set up last month.
In a statement released yesterday, DPT explained that it has invested over $30m (€25m) in the facility which, it added, will focus on the aseptic production small-volume parenterals, ophthalmics, preservative-free nasal sprays and ointments.
The CDMO highlighted the Lakewood unit’s new microbiology laboratory, sterility and endotoxin testing capacity and environmental monitoring capabilities.
The centre, which is also equipped with class A filling suites, class B & C support suites and Class D component preparation areas, is part of a restructuring project that has seen DPT establish centres for R&D, analytical development and technology transfer.
Speaking at the time, DPT spokesman JJ Feik said: “The industry is ready for a service provider who is focused on providing solutions for clinical, small-lot, and large scale sterile manufacturing needs.”
NextPharma’s Belgian steriles facility opens for business
Sterile product development was also a focus for NextPharma Technologies this month with the official opening, on April 1, of a new dedicate centre in Braine-l'Alleud, Belgium.
The unit, first covered by Outsourcing-pharma last July, is, according to NextPharma, “specifically designed to meet the growing demand for formulation development and production of sterile investigational medicinal products.”
NextPharma explained that services offered cover pre-formulation through to lyophilisation capacity for Phase I and II trial supplies, and added that it has the capability to scale up for Phase III and commercial manufacture.
Sean Marett, MD of product development services, said: “We have already successfully undertaken ten development projects in the SPDC, and we have a strongly growing order book which reflects our ability to provide a more efficient and faster option [for sterile pharmaceutical manufacturing].”
Vetter’s Chicago cleanrooms on track
Germany drug delivery systems supplier Vetter also highlighted the development of its sterile manufacturing offering, announcing that expansion of cleanroom infrastructure at its Chicago, US facility is on track to complete next month.
The new unit, which is intended to increase Vetter’s development services capacity when it becomes fully operational in Q4, will support pre-clinical through to phase II development projects.
Vetter is installing some 24,000 sqft of microbiology and chemistry laboratories, including several cleanrooms one of which, featuring a Bosch MHI 2020 automated vial filler that will focus on high-value biopharmaceuticals.
The other cleanroom will operate as a semi-automated filling unit for liquid products and, according to Vetter, will be compatible with a range of packaging formats, including vials, syringes and cartridges.
Vetter also said that it is building a cleanroom that will be used for the filling of pre-sterilised syringes.