p>Contract development and manufacturing organizations invested in new equipment and systems in 2014.
Rentschler Biotechnologie GmbH has invested $32 million to build a twin system with two 3000-L stainless-steel bioreactors at the company’s site in Laupheim, Germany. The twin system, which should be operational in early 2017, is designed for running two main bioreactors in parallel with one shared downstream processing unit. It will be integrated into the existing 3000-L GMP line and will more than double the production capacities for cell culture-derived proteins.
SAFC Commercial has installed a new commercial-scale continuous flow reactor at its Sheboygan, WI, facility with capacity to produce up to 150 kg of product per day. The reactor is complemented by a smaller pilot-scale continuous flow reactor that is being fabricated at a nearby Milwaukee facility to carry out process optimization studies and manufacturing capability of up to 30 kg of product per day.
Gallus BioPharmaceuticals is using an ambr15 micro bioreactor system from TAP Biosystems to optimize process development and clone selection of novel antibody therapeutics and biosimilars in the company’s process development facility in St. Louis, MO. The system is being used for clone selection programs to determine which chinese hampster ovary cell lines are stable and produce the highest titre monoclonal antibodies. The scientists use the ambr system to optimize media selection and feed strategies for these mAbs, which are being developed as antibody therapeutics and biosimilars.
Oral dosage forms
Bend Research, a division of Capsugel Dosage Form Solutions (DFS), has installed its first commercial-scale spray dryer at its R&D facility in Bend, OR. The new, high-capacity pharmaceutical spray dryer can be used for scale-up, quality-by-design, and the production of appropriate toxicology study supplies. The installation is part of the company’s multi-stage, $20 million expansion to enhance commercial manufacturing capabilities for spray-dried dispersions at its facilities in Oregon. The expansion is expected to be complete by mid-2015.
Molecular Profiles has invested in GMP hot-melt extrusion technology along with other milling equipment. The expansion is part of a wider project focusing on enabling technologies to accelerate formulation development, particularly for complex molecules that are difficult to progress. The company opened its new clinical production site in July 2013 following a successful inspection from the UK Medicines and Healthcare products Regulatory Agency.
Aesica Pharmaceuticals is adding services in its oral solids capability including a new roller compaction unit for dry granulation production in Zwickau, Germany. The new roller compaction unit uses a continuous production step that enhances product uniformity and has been undertaken following a market demand for pharmaceutical formulation technologies that enable the formulation of APIs otherwise inhibited by the presence of water.
Onyx Scientific, a UK-based CRO, has announced plans to invest in continuous flow manufacturing to allow its customers to explore alternatives during product research and development programs. The company intends to adopt a more novel approach to manufacturing API in a bid to overcome the often time-consuming and costly process of batch manufacturing.
Hovione and Merrion Pharmaceuticals are partnering on the use of Merrion’s patented GIPET absorption-enhancing technology by Hovione clients. Hovione will use GIPET as a method to address the permeability limitations of Biopharmaceutics Classification System class III and IV drugs and to develop tablet formulations for compounds that otherwise may have been administered by injection.
Filling and packaging
Jones Packaging has invested in a fully automated solid-dose plastic vial filling line. The line is operating in the company’s contract packaging services facility in the greater Toronto area and is capable of filling 12 million vials annually. The line includes carding and blistering for a market-ready packaging solution.
Almac has added new blistering technology at their US packaging facility in Audubon, PA, as a solution to ease the transition between clinical and commercial launch of blister products. The Klockner EAS blister line can produce a range of blister formats processing both thermoform and coldform materials.
Aesica Pharmaceuticals S.r.l. has announced the launch of a QAD integrated serialization system at its site in Pianezza to comply with change from China’s Food and Drug Administration (CFDA). The new requirements brought forward by CFDA cut the serialization implementation deadline from 12 months to three months.