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Implementation of a fully integrated continuous manufacturing line for direct compression and coating at a commercial pharmaceutical facility – Part 1: Operational considerations and control strategy
Contributor(s):: Conway, Stephen L., Rosas, Juan G., Overton, Paul, Tugby, Neil, Cryan, Phillip, Witulski, Frank, Hurley, Samantha, Wareham, Laura, Tantuccio, Anthony, Ramasamy, Manoharan, Lalloo, Anita, Gibbs, Mason, Meyer, Robert F.
We implement a fully integrated continuous manufacturing (CM) line for direct compression and coating of a pharmaceutical oral solid dosage form in a commercial production facility. In this first paper of a two-part series, we describe process design and operational choices made to introduce CM...
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Regions of attainable particle sizes in continuous and batch crystallization processes
Contributor(s):: Vetter, Thomas, Burcham, Christopher L., Doherty, Michael F.
Process alternatives for continuous crystallization, i.e., cascades of mixed suspension, mixed product removal crystallizers (MSMPRCs) and plug flow crystallizers (PFCs), as well as batch crystallizers are discussed and modeled using population balance equations. The attainable region approach...
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Process modelling and simulation for continuous pharmaceutical manufacturing of ibuprofen
Contributor(s):: Jolliffe, HG, Gerogiorgis, DI
Pharmaceutical corporations face rapidly rising process Research Article and development (R&D) as well as production costs due to globalised competition. Batch production processes are dominant in the pharmaceutical industry and have multiple advantages, including equipment flexibility,...
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Process Design and Optimization for the Continuous Manufacturing of Nevirapine, an Active Pharmaceutical Ingredient for HIV Treatment
Contributor(s):: Diab, S, McQuade, DTGupton, BF, Gerogiorgis, DI
The development of efficient and cost-effective manufacturing routes toward HIV active pharmaceutical ingredients (APIs) is essential to ensure their global and affordable access. Continuous pharmaceutical manufacturing (CPM) is a new production paradigm for the pharmaceutical industry whose...
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Process design applied to optimise a directly compressible powder produced via a continuous manufacturing process
Contributor(s):: Gonnissen, Y., Goncalves, S. I. V., De Geest, B. G., Remon, J. P., Vervaet, C.
Manufacturing of 'ready-to-compress' powder mixtures for direct compression was performed by spray drying, without granulation, milling and/or blending steps in between spray drying and compaction. Powder mixtures containing acetaminophen, mannitol, erythritol, maltodextrin, crospovidone,...
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Plantwide design and economic evaluation of two Continuous Pharmaceutical Manufacturing (CPM) cases: Ibuprofen and artemisinin
Contributor(s):: Jolliffe, HG, Gerogiorgis, DI
Increasing Research Article and Development (R&D) costs, growing competition from generic manufacturers and dwindling market introduction rates for novel drug products bolster the efforts of pharmaceutical firms to secure competitiveness by investigating Continuous Pharmaceutical Manufacturing...
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Pharmaceutical crystallisation processes from batch to continuous operation using MSMPR stages: Modelling, design, and control
Contributor(s):: Su, Qinglin, Nagy, Zoltan K., Rielly, Chris D.
In pharmaceuticals manufacturing, the conversion of conventional batch crystallisations to continuous mode has the potential for intensified, compact operation and more consistent production via quality-by-design. A pragmatic conversion approach is to utilise existing stirred tank batch...
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Model-based comparison of batch and flow syntheses of an active pharmaceutical ingredient using heterogeneous hydrogenation
Contributor(s):: Kim, J, Yonekura, HWatanabe, T, Yoshikawa, S, Nakanishi, H, Badr, S, Sugiyama, H
This work presents a model-based comparison of the batch and flow syntheses for doripenem, which is an antibiotic active pharmaceutical ingredient. The targeted reaction is heterogeneous hydrogenation, the most widely used method for reduction reaction in drug syntheses. We developed rigorous...
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Fit-for-Purpose Miniature NIR Spectroscopy for Solid Dosage Continuous Manufacturing
Contributor(s):: Karry, Krizia, Singh, Ravendra, Muzzio, Fernando
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Continuous manufacturing of drug substance and small molecules: process and equipment view
Contributor(s):: Yazdanpanah, Nima
The continuous manufacturing of pharmaceutical compounds and fine chemicals is in high interest for the industry due to significant technical, quality, and economical advantages. This manufacturing method has its own challenges. Beside the more efficient, safer, and greener synthesis rout, a new...