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Olena Gligorich
Olena brings over 16 years of business and biotechnology industry leadership experience to advise companies on how to achieve their goals through directing decision making and impeccable...
https://cmkc.usp.org/members/2480
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Jefferson Silva
https://cmkc.usp.org/members/1536
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The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing
Contributor(s):: Adam C Fisher, Mark-Henry Kamga, Cyrus Agarabi, Kurt Brorson, Sau L Lee, Seongkyu Yoon
There is a trend across the pharmaceutical sector toward process intensification and continuous manufacturing to produce small-molecule drugs or biotechnology products. For biotechnology products, advancing the manufacturing technology behind upstream and downstream processes has the potential to...
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The development and validation of a quality by design based process analytical tool for the inline quantification of Ramipril during hot-melt extrusion
Contributor(s):: Dadou, Suha, Senta-Loys, Zoe, Almajaan, Ammar, Li, Shu, Jones, David, Healy, Anne, Tian, Yiwei, Andrews, Gavin
Continuous processing is superseding conventional batch processing as a means of manufacturing within the pharmaceutical Research Article/industry. This paradigm shift has led to the implementation of Process Analytical Technology (PAT) as a semi-automatic, predictive tool offering real-time...
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Residence Time Distribution (RTD)-Based Control System for Continuous Pharmaceutical Manufacturing Process
Contributor(s):: Bhaskar, Aparajith, Singh, Ravendra
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Raw material variability of an active pharmaceutical ingredient and its relevance for processability in secondary continuous pharmaceutical manufacturing
Contributor(s):: Stauffer, F, Vanhoorne, VPilcer, G, Chavez, PF, Rome, S, Schubert, MA, Aerts, L, De;Beer, T
Active Pharmaceutical Ingredients (API) raw material variability is not always thoroughly considered during pharmaceutical process development, mainly due to low quantities of drug substance available. However, synthesis, crystallization routes and production sites evolve during product...
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Qualitative Assessment of a Multi-Scale, Compartmental PBM-DEM Model of a Continuous Twin-Screw Wet Granulation Process
Contributor(s):: Barrasso, Dana, Ramachandran, Rohit
Wet granulation processes play a crucial role in solid oral dosage manufacturing processes. However, they are often designed empirically with poor efficiency. To implement quality-by-design, a more scientific understanding is desired to predict the effects of process and equipment design and...
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Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients
Contributor(s):: Malwade, CR, Qu, HY
Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities....
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Process Analytical Technology Tools for Monitoring Pharmaceutical Unit operations: A Control Strategy for Continuous Process Verification
Contributor(s):: Kim, Eun, Kim, Ji, Kim, Min-Soo, Jeong, Seong, Choi, Du
Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls...
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Pharmaceutical manufacturing and the quality by design (QBD), process analytical technology (PAT) approach
Contributor(s):: Murphy, Trevor, O’ Mahony, Niall, Panduru, Krishna, Riordan, Daniel, Walsh, Joseph
This paper is the result of a literature review focusing on the application of process analytical technology (PAT) for the pharmaceutical industry in conjunction with the quality by design (QBD) framework. PAT and the QBD framework put forward by the FDA, offer a holistic approach to...
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Powder composition monitoring in continuous pharmaceutical solid-dosage form manufacturing using state estimation-Proof of concept
Contributor(s):: Destro, Francesco, Munoz, Salvador Garcia, Bezzo, Fabrizio, Barolo, Massimiliano
In continuous solid-dosage form manufacturing, the powder feeding system is responsible for supplying downstream the correct formulation of the drug product ingredients. The composition of the powder delivered by the feeding system is inferred from the measurements of powder mass flow from the...
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Near-infrared Spectroscopy for the In-line Characterization of Powder Voiding Part I: Development of the Methodology
Contributor(s):: Ropero, Jorge, Beach, Lauren, Alcala, Manel, Rentas, Raizza, Dave, Rajesh N., Romanach, Rodolfo J.
In-line near-infrared spectroscopy (NIR) spectra were acquired and analyzed to assess the relationship between physical and chemical properties of voiding powders and their spectral changes. NIR spectra were obtained for powders voiding from a conical glass funnel while the powder flow was...
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Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production
Contributor(s):: Lee, SL, O'Connor, TFYang, XC, Cruz, CN, Chatterjee, S, Madurawe, RD, Moore, CMV, Yu, LX, Woodcock, J
Currently, there is a high level of interest in the pharmaceutical industry in continuous-manufacturing strategies, integrated with online-monitoring tools, that are designed, optimized, and controlled using advanced, model-predictive systems. These strategies can accelerate the full...
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Managing API raw material variability during continuous twin-screw wet granulation
Contributor(s):: Stauffer, F, Vanhoorne, VPiker, G, Chavez, PF, Vervaet, C, De;Beer, T
Very few studies have investigated the impact of raw material variability upon the granule critical quality attributes (CQAs) produced via twin-screw wet granulation (i.e., granule size distribution, density, flowability). In this study, the impact of the raw material variability of an active...
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Integrated continuous manufacturing in pharmaceutical industry: current eolutionary steps toward revolutionary future
Contributor(s):: Nada A Helal, Ola Elnoweam, Heba Abdullah Eassa, Ahmed M Amer, Mohamed Ashraf Eltokhy, Mohamed A Helal, Heba A Fayyaz, Mohamed Ismail Nonou
Continuous manufacturing (CM) has the potential to provide pharmaceutical products with better quality, improved yield and with reduced cost and time. Moreover, ease of scale-up, small manufacturing footprint and on-line/in-line monitoring and control of the process are other merits for CM....
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Inline UV/Vis spectroscopy as PAT tool for hot-melt extrusion
Contributor(s):: Wesholowski, Jens, Prill, Sebastian, Berghaus, Andreas, Thommes, Markus
Hot-melt extrusion on co-rotating twin screw extruders is a focused technology for the production of pharmaceuticals in the context of Quality by Design. Since it is a continuous process, the potential for minimizing product quality fluctuation is enhanced. A typical application of hot-melt...
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Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation
Contributor(s):: Patil, H, Tiwari, RV, Repka, MA
Hot-melt extrusion (HME) is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market. In drug discovery and development, industry estimates that more than 50% of active pharmaceutical ingredients currently...
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Effects of Process and Design Parameters on Granule Size Distribution in a Continuous High Shear Granulation Process
Contributor(s):: Meng, Wei, Oka, Sarang, Liu, Xue, Omer, Thamer, Ramachandran, Rohit, Muzzio, Fernando J.
Wet granulation is widely used in the pharmaceutical industry. This advantageous technology is capable of enhancing compression and powder handling, decreasing ingredient segregation, and promoting blend and content uniformity. Currently, a high level of interest exists in the continuous version...
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Downstream processing from melt granulation towards tablets: In-depth analysis of a continuous twin-screw melt granulation process using polymeric binders
Contributor(s):: Grymonpre, W., Verstraete, G., Vanhoorne, V., Remon, J. P., De Beer, T., Vervaet, C.
The concept of twin-screw melt granulation (TSMG) has steadily (re)-gained interest in pharmaceutical formulation development as an intermediate step during tablet manufacturing. However, to be considered as a viable processing option for solid oral dosage forms there is a need to understand all...
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Data reconciliation in the Quality-by-Design (QbD) implementation of pharmaceutical continuous tablet manufacturing
Contributor(s):: Su, Qinglin, Bommireddy, Yasasvi, Shah Yash, Ganesh, Sudarshan, Moreno, Mariana, Liu, Jianfeng, Gonzalez, Marcial, Yazdanpanah, Nima, O'Connor, Thomas, Reklaitis, Gintaras V., Nagy, Zoltan K
Data provided by in situ sensors is always affected by some level of impreciseness as well as uncertainty in the measurements due to process operation disturbance or material property variance. In-process data precision and reliability should be considered when implementing active product quality...
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Design and Commercialization of an End-to-End Continuous Pharmaceutical Production Process: A Pilot Plant Case Study
Contributor(s):: Testa, Christopher J., Hu, Chuntian, Shvedova, Khrystyna, Wu, Wei, Sayin, Ridade, Casati, Federica, Halkude, Bhakti S., Hermant, Paul, Shen, Dongying Erin, Ramnath, Anjana, Su, Qinglin, Born, Stephen C., Takizawa, Bayan, Chattopadhyay, Saptarshi, O'Connor, Thomas F., Yang, Xiaochuan, Ramanujam, Sukumar, Mascia, Salvatore
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 manufacturing and advances in...
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Crystal and Particle Engineering Strategies for Improving Powder Compression and Flow Properties to Enable Continuous Tablet Manufacturing by Direct Compression
Contributor(s):: Chattoraj, Sayantan, Sun, Changquan Calvin
Continuous manufacturing of tablets has many advantages, including batch size flexibility, demand-adaptive scale up or scale down, consistent product quality, small operational foot print, and increased manufacturing efficiency. Simplicity makes direct compression the most suitable process for...
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Control strategy definition for a drug product continuous wet granulation process: Industrial case study
Contributor(s):: Chavez, Pierre-François, Stauffer, Fanny, Eeckman, Frédéric, Bostijn, Nils, Didion, David, Schaefer, Cédric, Yang, Hong, El Aalamat, Yousef, Lories, Xavier, Warman, Martin, Mathieu, Benoit, Mantanus, Jérôme
This paper describes the specific control strategy of the commercial manufacturing process of an immediate release tablet formulation based on continuous twin-screw wet granulation. This control strategy has been defined by a multidisciplinary team using an enhanced approach, in alignment with...
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Continuous twin screw granulation: Impact of microcrystalline cellulose batch-to-batch variability during granulation and drying - A QbD approach
Contributor(s):: Portier, Christoph, Vigh, Tamas, Di Pretoro, Giustino, Leys, Jan, Klingeleers, Didier, De Beer, Thomas, Vervaet, Chris, Vanhoorne, Valerie
Despite significant advances in the Research Article domain of continuous twin screw granulation, limited information is currently available on the impact of raw material properties, especially considering batch-to-batch variability. The importance of raw material variability and subsequent...
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Continuous manufacturing of co-crystals: challenges and prospects
Contributor(s):: Chavan, Rahul, Thipparaboina, Rajesh, Yadav, Balvant, Shastri, Nalini
The last decade has witnessed extensive growth in the field of co-crystallization for mitigating the solubility and dissolutionrelated issues of poorly soluble drugs. This is largely because co-crystals can modify the physicochemical properties of drugs without any covalent modification in the...