Continuous manufacturing

Abstract With the implementation of advanced manufacturing concepts (e.g., continuous operation, integration of different process routes and modular manufacturing), control of the process and the related product quality becomes more complex. Unlike traditional in-process controls and end-product…
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Abstract Continuous manufacturing offers advantages over traditional batch methods, including agility, efficiency, and sustainability. However, transitioning to continuous manufacturing in process development is challenging due to the need for early adoption of industrial-scale equipment.…
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Abstract Background/Objectives: The oral delivery of large-molecule drugs remains challenging due to poor solubility, perdemeability, and stability in the gastrointestinal tract, resulting in low bioavailability. In this study, hot melt extrusion (HME) was investigated as a solvent-free…
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Purpose Understanding batch-to-batch variation of excipients and correlating this to process performance is a key concept of Quality-by-Design for pharmaceutical product development. In this study, the effect of batch-to-batch variation in material properties of milled lactose monohydrate on…
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Abstract Process analytical technology (PAT) tools are an important part of process monitoring and control in pharmaceutical continuous manufacturing (CM) that help ensure product quality. However, there is hesitancy to adopt PAT due, in part, to the high start-up costs. A portion of the cost is…
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The pharmaceutical industry has been shifting towards continuous manufacturing, specifically for tablet production. Compared to batch processing, continuous tableting exhibits higher process efficiency, better process control, reduced footprint, and consistent product quality. Understanding mass…
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Abstract Oral drug delivery remains the preferred method of drug administration but due to poor solubility many active pharmaceutical ingredients (APIs) are ill suited to this. A number of methods to improve solubility of poorly soluble Biopharmaceutical Classification System (BCS) Class II drugs…
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Abstract In recent years, continuous manufacturing (CM) has become increasingly popular in the pharmaceutical industry for the production of oral solid dosage (OSD) forms. Most of the newly developed active pharmaceutical ingredients (APIs) nowadays are extremely cohesive and sticky with a mean…
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Abstract Process Analytical Technology (PAT) plays a crucial role in the design of today’s manufacturing lines as continuous manufacturing becomes more important. Until now PAT tools to measure the ribbon solid fraction (SFribbon) in-line are not commonly used in roll compaction. The aim of this…
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Many challenges – one solution: Fumed silica as well as precipitated silica and silicates from Evonik are some of the most important and highly utilized pharmaceutical excipients. Whether you manufacture medicines for solid, semi-solid or liquid dosing, we support you at every stage of product…
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