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1. Utilizing PAT to Monitor and Control Bulk Biotech Processes

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   Document | 27 Mar 2024 | Contributor(s):: Rick E. Cooley

   1.What is and isn’t PAT? 2.Implementing PAT in Manufacturing: What does it take? 3.Characteristics of bulk, biotech API processes 4.Why PAT? 5.Review of PAT technologies utilized 6.PAT application examples

2. The use of rheology to elucidate the granulation mechanisms of a miscible and immiscible system during continuous twin-screw melt granulation

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Monteyne, Tinne, Heeze, Liza, Mortier, Severine Therese F. C., Oldorp, Klaus, Nopens, Ingmar, Remon, Jean-Paul, Vervaet, Chris, De Beer, Thomas

   Twin-screw hot melt granulation (TS HMG) is a valuable, but still unexplored alternative to granulate temperature and moisture sensitive drugs in a continuous way. Recently, the material behavior of an immiscible drug-binder blend during TS HMG was unraveled by using a rheometer and differential...

3. Study of near Infrared Chemometric Models with Low Heterogeneity Films: The Role of Optical Sampling and Spectral Preprocessing on Partial Least Squares Errors

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Ortega-Zuñiga, Carlos, Reyes-Maldonado, Kerimar, Méndez, Rafael, Romañach, Rodolfo J.

   This study is focused on understanding absorption and scattering effects and their impact on the errors observed in near infrared calibration models developed using partial least squares regression able to predict the number of polypropylene film layers stacked together. The films provided a...

4. Quantification of Inkjet-Printed Pharmaceuticals on Porous Substrates Using Raman Spectroscopy and Near-Infrared Spectroscopy

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Edinger, M, Iftimi, LDMarkl, D, Al-Sharabi, M, Bar-Shalom, D, Rantanen, J, Genina, N

   The use of inkjet printing for pharmaceutical manufacturing is gaining interest for production of personalized dosage forms tailored to specific patients. As part of the manufacturing, it is imperative to ensure that the correct dose is printed. The aim of this study was to use inkjet printing...

5. Pharmaceutical manufacturing and the quality by design (QBD), process analytical technology (PAT) approach

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   Peer-reviewed journal | 09 Jun 2023 | 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...

6. PAT for pharmaceutical manufacturing process involving solid dosages forms

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Román-Ospino, Andrés D, Cárdenas, Vanessa Ortega-Zuñiga, Carlos, Singh, Ravendra

   This chapter summarizes important considerations to develop multivariate methods for pharmaceuticals process monitoring and quality control in solid dosages forms based on spectroscopic techniques. The stages described in each section aimed to explain relevant knowledge of the calibration...

7. Monitoring blend potency in a tablet press feed frame using near infrared spectroscopy

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Ward, Howard, Blackwood, Daniel, Polizzi, Mark, Clarke, Hugh

   A near-infrared (NIR) probe was installed into the feed frame of a rotary tablet press to monitor API concentration as a function of time. A series of step change experimental trials were completed, where a placebo blend was initially charged into the feed frame, and an active blend was layered...

8. Development of a tablet press feed frame lead lag determination model using in-line and off-line NIR measurements

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   Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Van;Hauwermeiren, D, Peeters, MPeeters, E, Cogoni, G, Yang, LA, De;Beer, T

   For continuous pharmaceutical manufacturing of oral solid dosages, it is essential that product quality is measured inline. In this application, a continuous rotary tablet press is used. The goal is a model-based assessment of the quality of the blend in the feed frame to determine whether the...