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Pharmaceutical Engineering & Drug Delivery

Real-Time Monitoring of Continuous Processes with Spectroscopic PAT-Tools

Nov 9, 2010
Daniel M. Koller
The aim of Process Analytical Technology (PAT) is to gain deeper insight in pharmaceutical manufacturing processes, replacing empirical approaches by knowledge-based procedures. A detailed understanding of the key parameters of a process and their impact on the product quality allows companies to “...

Raman Spectroscopy Combined with Small and Wide Angle X-Ray Scattering as a Non Destructive Quality Control Tool for Powder Compression Analytics in Pharmaceutical Applications

Nov 9, 2010
Nicolas Heigl
This study evaluates the feasibility of a combined use of small-wide angle X-ray scattering (SWAXS) and Raman spectroscopy as a non-invasive process analytical tool (PAT) for the analysis of pharmaceutical granulation and compression procedures. Placebo formulations containing Lactose monohydrate (...

Implementation of a Normalization Risk Assessment Tool to Link Design Space Inputs

Nov 9, 2010
Diana S. Hou
Risk analysis and assessment tools are a key component of Quality by Design (QbD) because they facilitate understanding, identifying, and documenting of risks affecting drug product quality attributes. As stated in the ICH Q8 guidelines, the “design space” is where a process generates a product...

Optimizing and Controlling High Value Processes Using the Principles of Quality-by-Design (QbD) Advanced Tools Such as Real-Time in-Situ Particle Characterization, in-Situ Mid-Infrared Spectrometry, and Reaction Calorimetry

Nov 9, 2010
Leen Schellekens
Quality by Design (QbD) is a concept applied to gain true process understanding utilizing tools such as Design of Experiment (DoE), Risk Management, and Process Analytical Technology (PAT). Utilization of these principles and tools not only allow the chemist, engineer, or formulator to optimize a...

Risk Based Roadmap for the Approval of Biosimilar Biologics

Nov 9, 2010
Henry Y. Wang
The development of biologics has grown significantly in recent years, due in part to the profitability for innovator companies, which currently enjoy exclusivity in the absence of “generic” biologics. In the U.S. There is currently no guideline in place for the approval of “biosimilar” biologics...

On-Line Monitoring of Roller Compaction Ribbon Density Using NIR Spectroscopy

Nov 9, 2010
Ryan McCann
Solid dosage forms, such as tablets and capsules, have been predominately manufactured through batch processes in pharmaceutical industry for years. The development of continuous manufacturing processes is of high interest to the pharmaceutical industry to reduce the huge costs associated with...

Quality by Design and Multivariate Process Representations

Nov 8, 2010
Jose Cardoso Menezes
Bioprocess design, development and manufacturing involve different goals and use different tools. At the design stage a cell-centric approach dominates. During development and especially later during manufacturing a process-centered perspective prevails as if biomanufacturing performance was...

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