At-line process analytical technology (PAT) for more efficient scale up of biopharmaceutical microfiltration unit operations

2015 ◽  
Vol 32 (1) ◽  
pp. 108-115 ◽  
Author(s):  
Douglas S. Watson ◽  
Kristi R. Kerchner ◽  
Sean S. Gant ◽  
Joseph W. Pedersen ◽  
James B. Hamburger ◽  
...  
Keyword(s):  
Process Analytical Technology ◽  
Scale Up ◽  
Unit Operations ◽  
Line Process ◽  
Analytical Technology

scholarly journals Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification

Pharmaceutics ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 919
Author(s):  
Eun Ji Kim ◽  
Ji Hyeon Kim ◽  
Min-Soo Kim ◽  
Seong Hoon Jeong ◽  
Du Hyung Choi
Keyword(s):  
Pharmaceutical Industry ◽  
Product Quality ◽  
Real Time ◽  
Control Strategy ◽  
Process Analytical Technology ◽  
Drug Product ◽  
Continuous Process ◽  
Process Verification ◽  
Unit Operations ◽  
Analytical Technology

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 and predefined material attributes and intermediate quality attributes (IQAs) during processing may provide greater assurance of product quality than end-product testing. The efficient analysis method to monitor the relationship between process and quality should be used. Process analytical technology (PAT) was introduced to analyze IQAs during the process of establishing regulatory specifications and facilitating continuous manufacturing improvement. Although PAT was introduced in the pharmaceutical industry in the early 21st century, new PAT tools have been introduced during the last 20 years. In this review, we present the recent pharmaceutical PAT tools and their application in pharmaceutical unit operations. Based on unit operations, the significant IQAs monitored by PAT are presented to establish a control strategy for CPV and real time release testing (RTRT). In addition, the equipment type used in unit operation, PAT tools, multivariate statistical tools, and mathematical preprocessing are introduced, along with relevant literature. This review suggests that various PAT tools are rapidly advancing, and various IQAs are efficiently and precisely monitored in the pharmaceutical industry. Therefore, PAT could be a fundamental tool for the present QbD and CPV to improve drug product quality.

scholarly journals Testing the Limits of a Portable NIR Spectrometer: Content Uniformity of Complex Powder Mixtures Followed by Calibration Transfer for In-Line Blend Monitoring

Molecules ◽  
2021 ◽  
Vol 26 (4) ◽  
pp. 1129
Author(s):  
Tibor Casian ◽  
Alexandru Gavan ◽  
Sonia Iurian ◽  
Alina Porfire ◽  
Valentin Toma ◽  
...  
Keyword(s):  
Process Analytical Technology ◽  
Content Uniformity ◽  
Spectral Variability ◽  
Calibration Transfer ◽  
Pharmaceutical Powder ◽  
Acceptance Limits ◽  
Line Process ◽  
Dynamic Acquisition ◽  
Dispersive Mixing ◽  
Analytical Technology

(1) Background: Portable NIR spectrometers gain more and more ground in the field of Process Analytical Technology due to the easy on-site flexibility and interfacing versatility. These advantages that originate from the instrument miniaturization, also come with a downside with respect to performance compared to benchtop devices. The objective of this work was to evaluate the performance of MicroNIR in a pharmaceutical powder blend application, having three active ingredients and 5 excipients. (2) Methods: Spectral data was recorded in reflectance mode using static and dynamic acquisition, on calibration set samples developed using an experimental design. (3) Results: The developed method accurately predicted the content uniformity of these complex mixtures, moreover it was validated in the entire calibration range using ±10% acceptance limits. With respect to at-line prediction, the method presented lower performance compared to a previously studied benchtop spectrometer. Regarding the in-line monitoring of the blending process, it was shown that the spectral variability-induced by dynamic acquisition could be efficiently managed using spectral pre-processing. (4) Conclusions: The in-line process monitoring resulted in accurate concentration profiles, highlighting differences in the mixing behaviour of the investigated ingredients. For the low dose component homogeneity was not reached due to an inefficient dispersive mixing.

Flow Water Proton NMR: In-Line Process Analytical Technology for Continuous Biomanufacturing

2019 ◽  
Vol 91 (21) ◽  
pp. 13538-13546 ◽  
Author(s):  
Marc B. Taraban ◽  
Katharine T. Briggs ◽  
Peter Merkel ◽  
Y. Bruce Yu
Keyword(s):  
Process Analytical Technology ◽  
Proton Nmr ◽  
Water Proton ◽  
Line Process ◽  
Analytical Technology

Protein Purification Techniques

2001 ◽  
Keyword(s):  
Cell Culture ◽  
Protein Purification ◽  
Mammalian Cell Culture ◽  
Scale Up ◽  
Analytical Techniques ◽  
Structure And Function ◽  
Unit Operations ◽  
Practical Guidelines ◽  
P Proteins ◽  
And Function

Proteins are an integral part of molecular and cellular structure and function and are probably the most purified type of biological molecule. In order to elucidate the structure and function of any protein it is first necessary to purify it. Protein purification techniques have evolved over the past ten years with improvements in equipment control, automation, and separation materials, and the introduction of new techniques such as affinity membranes and expanded beds. These developments have reduced the workload involved in protein purification, but there is still a need to consider how unit operations linked together to form a purification strategy, which can be scaled up if necessary. The two Practical Approach books on protein purification have therefore been thoroughly updated and rewritten where necessary. The core of both books is the provision of detailed practical guidelines aimed particularly at laboratory scale purification. Information on scale-up considerations is given where appropriate. The books are not comprehensive but do cover the major laboratory techniques and common sources of protein. Protein Purification Techniques focuses on unit operations and analytical techniques. It starts with an overview of purification strategy and then covers initial extraction and clarification techniques. The rest of the book concentrates on different purification methods with the emphasis being on chromatography. The final chapter considers general scale-up considerations. Protein Purification Applications describes purification strategies from common sources: mammalian cell culture, microbial cell culture, milk, animal tissue, and plant tissue. It also includes chapters on purification of inclusion bodies, fusion proteins, and purification for crystallography. A purification strategy that can produce a highly pure single protein from a crude mixture of proteins, carbohydrates, lipids, and cell debris to is a work of art to be admired. These books (available individually or as a set)are designed to give the laboratory worker the information needed to undertake the challenge of designing such a strategy.

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