Continuous manufacturing promises more efficient production than batch manufacturing, with smaller-footprint equipment that can more flexibly produce small or large volumes with fewer scale-up difficulties and the potential for tighter control. Process development in continuous manufacturing is more efficient too; with a short residence time, the effects of changing process variables can be evaluated quickly. Other industries (e.g., food, chemicals, plastics) use continuous manufacturing, and it is taking hold in both solid-dosage and biopharmaceutical production.
In the past year, Pharmaceutical Technology has been tracking trends in continuous processes for solid dosage manufacturing, such as model-predictive design, the use of process analytical technology for implementation of closed-loop process control, and news in continuous granulation and hot-melt extrusion. On Tuesday morning, March 18, at INTERPHEX 2014 in New York City, Pharmaceutical Technology will host several experts on Innovation Stage 2 (located on the show floor in the INTERPHEX Connects Networking Area) who will highlight developments in continuous solid-dosage processing. From 10:30-11:15 am, two presentations will focus on hot-melt extrusion, a continuous process that is being used to improve the solubility of poorly-soluble drugs and create innovative dosage forms. Gain insight from hot-melt extrusion expert Charlie Martin, president of Leistritz Extrusion, who will explain twin-screw extrusion theories, as well as give practical tips and share recent test results, and hear Tony Listro, managing director of Foster Delivery Science, share his experience in extrusion and shaping technologies for combination drug-device products. From 11:15 am-12 pm, gain a broad view of continuous solid-dosage manufacturing from Doug Hausner of the Engineering Research Center for Structured Organic Particulate Systems at Rutgers, the State University of New Jersey, and learn the latest is enabling integrated system control from Pamela Bruen Docherty, Life Sciences industry manager at Siemens USA.
Pharmaceutical Technology’s sister publication, BioPharm International, focuses on the biopharmaceutical industry, which is under pressure to improve downstream processing (i.e., purification and separation) to keep up with upstream processes, and is exploring the potential of the higher efficiency of continuous processing, such as continuous chromatography. On Wednesday, March 19 from 1:30–2:15 pm, experts will discuss continuous manufacturing for biologic drugs. John-Bonham Carter, vice-president of business development at Refine Technology, will discuss trends and challenges in continuous biomanufacturing, and Stéphanie Dubois, Cell Culture lab manager and applications specialist at ATMI will describe continuous cell-culture platforms and the challenges addressed by alternative technologies.
Another aspect of improved efficiency is the use of new facility designs. As reported in the Nov. 2013 Equipment & Processing Report, biopharmaceutical manufacturing is experiencing a shift to flexible, multiproduct facilities, which can be enhanced with single-use and modular technologies. From 2:15–3 pm on Wednesday, March 19, experts will share the latest trends in modular biopharmaceutical manufacturing systems. Pär Almhem, president of ModWave and Modular Partners, will discuss standardized modular facility solutions, and Parrish Galliher, Founder and CTO of Xcellerex, a GE Life Sciences Healthcare company, will explain how to rapidly enable flexible biomanufacturing in a new or existing facility.