Process Analytical Technology for Bioseparation Unit Operations

2011 ◽  
pp. 207-228
Keyword(s):  
Process Analytical Technology ◽  
Unit Operations ◽  
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.

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 Exploiting Fluorescent Reporter Molecules for Process Analytical Technology (PAT)

2009 ◽  
Vol 63 (3) ◽  
pp. 171-173 ◽  
Author(s):  
Tobias Broger ◽  
Res P. Odermatt ◽  
Pablo Ledergerber ◽  
Bernhard Sonnleitner
Keyword(s):  
Process Analytical Technology ◽  
Fluorescent Reporter ◽  
Analytical Technology

Process analytical technology for bakery industry: A review

2019 ◽  
Vol 42 (5) ◽  
Author(s):  
Rifna E. Jerome ◽  
Sushil K. Singh ◽  
Madhuresh Dwivedi
Keyword(s):  
Process Analytical Technology ◽  
Bakery Industry ◽  
Analytical Technology
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