A Review of PAT Strategies in Secondary Solid Oral Dosage Manufacturing of Small Molecules

Laske, Stephan; Paudel, Amrit; Scheibelhofer, Otto

doi:10.1016/j.xphs.2016.11.011

Cited by 73 publications

(25 citation statements)

References 180 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…While PAT has been successfully implemented as a pillar of process control for numerous small-molecule pharmaceuticals [8,9], the high complexity of biopharmaceutical proteins and the close chemical similarity of contaminants impose a challenge for finding suitable PAT methods [10]. Ideally, a PAT method would be able to differentiate between product, process-related contaminants, and product-related contaminants in real-time.…”

Section: Introductionmentioning

confidence: 99%

A critical review of recent trends, and a future perspective of optical spectroscopy as PAT in biopharmaceutical downstream processing

2020

View full text Add to dashboard Cite

As competition in the biopharmaceutical market gets keener due to the market entry of biosimilars, process analytical technologies (PATs) play an important role for process automation and cost reduction. This article will give a general overview and address the recent innovations and applications of spectroscopic methods as PAT tools in the downstream processing of biologics. As data analysis strategies are a crucial part of PAT, the review discusses frequently used data analysis techniques and addresses data fusion methodologies as the combination of several sensors is moving forward in the field. The last chapter will give an outlook on the application of spectroscopic methods in combination with chemometrics and model predictive control (MPC) for downstream processes.

show abstract

Section: Introductionmentioning

confidence: 99%

A critical review of recent trends, and a future perspective of optical spectroscopy as PAT in biopharmaceutical downstream processing

2020

View full text Add to dashboard Cite

show abstract

“…Introduced by the Food and Drug Administration (FDA) in 2004, the adoption of PAT is part of a scientific risk-based framework intended to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance (FDA, 2004). A PAT framework consists of designing and developing continuous monitoring and control strategies to understand and improve the CQAs of pharmaceutical products through inline, online or at-line measurements (Fonteyne et al, 2012;Laske et al, 2017;Wahl et al, 2013). It must be emphasised, however, the concepts and implementation of PAT and QbD framework is not new as process analysis and control have been widely adopted in many other industries (oil refinery, food, plastic and semiconductor).…”

Section: Introductionmentioning

confidence: 99%

The development of an inline Raman spectroscopic analysis method as a quality control tool for hot melt extruded ramipril fixed-dose combination products

Andrews

Jones

Senta-Loys

et al. 2019

International Journal of Pharmaceutics

View full text Add to dashboard Cite

show abstract

“…One of the greatest challenges we faced in moving from first implementation of the probe to a working system was that decisions such as pre-processing proceed in parallel with probe commissioning, data gathering and experimental design thus in moving towards 'optimal' probe functionality it can be difficult to identify where attention needs to be focused. Such considerations are discussed further in a comprehensive technology review bringing together the experiences of multiple teams [29].…”

Section: Discussionmentioning

confidence: 99%

Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line

et al. 2018

View full text Add to dashboard Cite

This paper investigates the application of on-line near infra-red measurements as a means to measure blend uniformity in a continuous tableting line. Underlying all the monitoring and control methods is the ability to measure key tablet properties on-line at a rate suitable for control purposes. The use of NIR to determine any deviations in blend uniformity is demonstrated by interpreting the relevant spectral signature allowing quantitative information to be acquired for process monitoring and quality assurance. In addition to demonstrating the functionality of the NIR probe, the practical issues arising in the application are discussed. The composition of the blend was measured using an NIR probe over a range of concentrations and the results were calculated comparing sub unit dose scale of scrutiny of small populations. This was compared with predicted product quality for whole tablets over the whole production period. This technique has demonstrated how data collected online can be used to successfully predict the quality of the whole production run for the purposes of real time product quality assurance.

show abstract

A Review of PAT Strategies in Secondary Solid Oral Dosage Manufacturing of Small Molecules

Cited by 73 publications

References 180 publications

A critical review of recent trends, and a future perspective of optical spectroscopy as PAT in biopharmaceutical downstream processing

A critical review of recent trends, and a future perspective of optical spectroscopy as PAT in biopharmaceutical downstream processing

The development of an inline Raman spectroscopic analysis method as a quality control tool for hot melt extruded ramipril fixed-dose combination products

Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line

Contact Info

Product

Resources

About