NIR Spectroscopy as an Online PAT Tool for a Narrow Therapeutic Index Drug: Toward a Platform Approach Across Lab and Pilot Scales for Development of a Powder Blending Monitoring Method and Endpoint Determination

Talwar, Sameer; Pawar, Pallavi; Wu, Hsien-Ming; Sowrirajan, Koushik; Wu, S.Y.; Igne, Benoît; Friedman, Richard J.; Muzzio, Fernando J.; Drennen, James K.

doi:10.1208/s12248-022-00748-4

Cited by 6 publications

(5 citation statements)

References 59 publications

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“…Process intensification is crucial to the pharmaceutical industry minimizing cost and controlling particle engineering and final product characteristics. Further investigation should be performed to implement process-analytical technologies (PAT) during manufacturing, such as including NIR probes in the fluidized bed to quantify the amount of solvent remaining and determine the final point of the drying step during the coating process [ 19 , 35 , 36 ], to create a robust and highly controlled process.…”

Section: Discussionmentioning

confidence: 99%

Continuous Manufacturing of Cocrystals Using 3D-Printed Microfluidic Chips Coupled with Spray Coating

et al. 2023

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Using cocrystals has emerged as a promising strategy to improve the physicochemical properties of active pharmaceutical ingredients (APIs) by forming a new crystalline phase from two or more components. Particle size and morphology control are key quality attributes for cocrystal medicinal products. The needle-shaped morphology is often considered high-risk and complex in the manufacture of solid dosage forms. Cocrystal particle engineering requires advanced methodologies to ensure high-purity cocrystals with improved solubility and bioavailability and with optimal crystal habit for industrial manufacturing. In this study, 3D-printed microfluidic chips were used to control the cocrystal habit and polymorphism of the sulfadimidine (SDM): 4-aminosalicylic acid (4ASA) cocrystal. The addition of PVP in the aqueous phase during mixing resulted in a high-purity cocrystal (with no traces of the individual components), while it also inhibited the growth of needle-shaped crystals. When mixtures were prepared at the macroscale, PVP was not able to control the crystal habit and impurities of individual mixture components remained, indicating that the microfluidic device allowed for a more homogenous and rapid mixing process controlled by the flow rate and the high surface-to-volume ratios of the microchannels. Continuous manufacturing of SDM:4ASA cocrystals coated on beads was successfully implemented when the microfluidic chip was connected in line to a fluidized bed, allowing cocrystal formulation generation by mixing, coating, and drying in a single step.

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Section: Discussionmentioning

confidence: 99%

Continuous Manufacturing of Cocrystals Using 3D-Printed Microfluidic Chips Coupled with Spray Coating

et al. 2023

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“…In the production of traditional Chinese medicine tablets, specific technologies need to be used to monitor the mixing process to ensure the quality of the product. NIRS combined with the corresponding chemometrics algorithm can realize the online monitoring of the physical and chemical properties of the mixture, and can predict the mixing uniformity of the independent mixture samples produced under different process conditions, so as to predict the optimal mixing end point [3][4][5] .…”

Section: Mixing Process Monitoringmentioning

confidence: 99%

Design of Intelligent Near Infrared Spectroscopy Monitoring in the Production Process of Traditional Chinese Medicine Tablets

Cui

2023

Proceedings of the 2nd International Conference on Public Management, Digital Economy and Internet Technology, ICPDI 2023, Sept

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Traditional Chinese medicine tablets are very common in clinical application, and the market demand is large. Traditional Chinese medicine tablets are the most common dosage forms of traditional Chinese medicine. Its advantages are convenient and safe to take, easy to carry, accurate dose, and stable quality. In the production process of solid preparations of traditional Chinese medicine, due to the complexity of the components of traditional Chinese medicine, strict verification is needed to improve the quality control of the process to support the continuous and stable production of traditional Chinese medicine preparations. If the process technology is not mature, it will bring many unstable factors to the production of solid preparations of traditional Chinese medicine, such as tablet loosening, cracking, disintegration and so on. In order to improve the quality of traditional Chinese medicine tablets and ensure the smooth progress of production, in view of the common quality problems in the production of traditional Chinese medicine tablets, this paper designs near-infrared spectroscopy monitoring to improve the quality of traditional Chinese medicine tablets.

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“…Chemometric modeling is required to establish quantitative Raman models for each product quality attribute and process parameter . A large quantity of representative data is needed to build the models, hence requiring extensive time for data collection. , The biopharmaceutical industry is on a journey of shortening investigational new drug development time via various avenues in order to gain a more rapid entry into the clinical stage, saving patients’ lives as well as securing competitiveness in the market . Therefore, it is increasingly challenging to acquire the same quantity of data that used to be considered necessary for Raman model development in such an accelerated timeline.…”

Section: Introductionmentioning

confidence: 99%

Pioneering Just-in-Time (JIT) Strategy for Accelerating Raman Method Development and Implementation for Biologic Continuous Manufacturing

Feng,

Dunn,

Kargupta

et al. 2024

Anal. Chem.

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Raman spectroscopy is a popular process analytical technology (PAT) tool that has been increasingly used to monitor and control the monoclonal antibody (mAb) manufacturing process. Although it allows the characterization of a variety of quality attributes by developing chemometric models, a large quantity of representative data is required, and hence, the model development process can be time-consuming. In recent years, the pharmaceutical industry has been expediting new drug development in order to achieve faster delivery of life-changing drugs to patients. The shortened development timelines have impacted the Raman application, as less time is allowed for data collection. To address this problem, an innovative Just-in-Time (JIT) strategy is proposed with the goal of reducing the time needed for Raman model development and ensuring its implementation. To demonstrate its capabilities, a proof-of-concept study was performed by applying the JIT strategy to a biologic continuous process for producing monoclonal antibody products. Raman spectroscopy and online two-dimensional liquid chromatography (2D-LC) were integrated as a PAT analyzer system. Raman models of antibody titer and aggregate percentage were calibrated by chemometric modeling in real-time. The models were also updated in real-time using new data collected during process monitoring. Initial Raman models with adequate performance were established using data collected from two lab-scale cell culture batches and subsequently updated using one scale-up batch. The JIT strategy is capable of accelerating Raman method development to monitor and guide the expedited biologics process development.

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NIR Spectroscopy as an Online PAT Tool for a Narrow Therapeutic Index Drug: Toward a Platform Approach Across Lab and Pilot Scales for Development of a Powder Blending Monitoring Method and Endpoint Determination

Cited by 6 publications

References 59 publications

Continuous Manufacturing of Cocrystals Using 3D-Printed Microfluidic Chips Coupled with Spray Coating

Continuous Manufacturing of Cocrystals Using 3D-Printed Microfluidic Chips Coupled with Spray Coating

Design of Intelligent Near Infrared Spectroscopy Monitoring in the Production Process of Traditional Chinese Medicine Tablets

Pioneering Just-in-Time (JIT) Strategy for Accelerating Raman Method Development and Implementation for Biologic Continuous Manufacturing

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