A5082063494- Crystallization and Solubility Studies
- Innovative Microfluidic and Catalytic Techniques Innovation
- Granular flow and fluidized beds
- Drug Solubulity and Delivery Systems
- Advanced Statistical Process Monitoring
- Protein purification and stability
- Mineral Processing and Grinding
- Spectroscopy and Chemometric Analyses
- Process Optimization and Integration
- Fluid Dynamics and Mixing
- Fault Detection and Control Systems
- Analytical Chemistry and Chromatography
- Injection Molding Process and Properties
- Powder Metallurgy Techniques and Materials
- Spectroscopy Techniques in Biomedical and Chemical Research
- Viral Infectious Diseases and Gene Expression in Insects
- American Constitutional Law and Politics
- Microfluidic and Capillary Electrophoresis Applications
- Chemistry and Chemical Engineering
- Hemoglobinopathies and Related Disorders
- Catholicism and Religious Studies
- Tuberculosis Research and Epidemiology
- Big Data and Business Intelligence
- Additive Manufacturing and 3D Printing Technologies
- Electrohydrodynamics and Fluid Dynamics
Center for Drug Evaluation and Research
2016-2025
Quality Research
2021-2025
United States Food and Drug Administration
2015-2025
Princeton University
2004-2006
Georgetown University Medical Center
1960
Georgetown University
1960
The pharmaceutical industry faces multiple challenges (e.g., inefficient manufacturing techniques, quality control issues, and supply chain vulnerabilities) because of its current batch-wise approach to manufacturing. Recent regulatory support for continuous advances in process technologies have caused an increase interest from some drug manufacturers modernize their production processes. However, many these companies focused on hybrid processes, where only certain steps are continuous,...
Continuous manufacturing (CM) is an emerging technology in the pharmaceutical sector, and understanding of impact on product quality currently evolving. As final purification isolation step, crystallization has a significant physicochemical properties drug substance considered critical process step achieving continuous substances. Although many publications previously focused various innovative techniques to continuously make crystals with desired properties, engineering difficulties such as...
Encrustation is a risk factor that can cause product and process failure in continuous crystallization processes. Mitigation, prevention, control of encrustation have been extensively researched. Various mitigation strategies proposed the literature, such as coating crystallizer walls, use additives to kinetics, periodic steady-state operation show promising results delaying or preventing encrustation. Because increased interest industrial applications, it important understand this further....
Crystallization has a significant impact on the properties of active pharmaceutical ingredient (API) since it is final step in manufacturing drug substance and determines particle size distribution, purity, shape, polymorphs. Many publications have focused implementation Process Analytical Technology (PAT) tools for monitoring batch continuous operation; however, comprehensive method development validation Raman spectroscopy to monitor crystallization not been presented. This work...
We report here a fully automated, end-to-end, integrated continuous manufacturing process for small-molecule generic medication with built-in quality assurance. The entire fits into box of 30.7 m2 modular footprint and total residence time less than 30 h, throughput up to 40.3 × 106 tablets per year.
Using process modeling to understand dynamics and potentially explore the design space of a crystallization is difficult because its complex nature with many factors at play, such as initial concentration, supersaturation, seeding strategy, flow pattern. In this work, systematic approach applied sequentially estimate growth nucleation rate cooling carbamazepine various conditions in batch operation. Different formulations kinetic expressions are tested model discrimination exercise obtain...
Pharmaceutical crystallization affects the properties of APIs as it determines purity and crystal size distribution, among other attributes. This work presents two CLD–CSD models, theoretical empirical, for a model compound.
Much less waste was generated by the end-to-end Integrated Continuous Manufacturing (ICM) process compared to batch process.
Abstract The COVID-19 pandemic has led to increased usage of hand sanitizer products by the public prevent spread and decrease likelihood acquiring disease. increase in demand also an number manufacturers. This work describes FDA’s Center for Drug Evaluation Research (CDER) laboratories efforts develop tests assess quality containing ethanol or isopropanol as primary active ingredient. were evaluated ingredient content determination 12 impurities listed FDA Hand Sanitizer Temporary Guidance,...