Process analytical technology (PAT) for biopharmaceutical products (original) (raw)
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Process analytical technology (PAT) needs and applications in the bioprocess industry
2006
Process analytical technologies have been applied to manufacturing processes (pulp and paper, chemical and petroleum) for decades. Recently, the US Food and Drug Administration (FDA) has, however, redefined the phrase and implemented it into an initiative focusing on improving several aspects of the pharmaceutical industry. The European Agency for the Evaluation of Medicinal Products (EMEA), has also been active and formed a PAT team in 2003. The PAT initiative was initially intended for traditional pharmaceutical manufacturers, but the FDA's PAT guidance now clearly states that it applies to all manufacturers of human and veterinary drug products, as well as biologics regulated by the FDA's Center for Drug Evaluation and Research (CDER) and the Center for Veterinary Medicine (CVM). Basically, PAT involves a fundamental shift from testing the quality of the finished drug product, to building quality into products by testing at several intermediate steps. It specifically requires that quantifiable, causal, and predictive relationships be established amongst raw materials, the manufacturing process, and final product quality. It is believed that PAT may not bring dramatic changes overnight, but years from now, it may be seen as an initiative that helped foster a period of innovation, efficiency, and expansion for the biopharmaceutical industry. In this report, the impact and potential effects of PAT on the biotechnological production of pharmaceuticals is assessed. Hence, we define BioPAT as process analytical technologies applied throughout development, scale-up and commercial scale bioprocess-based production of drug substances. In this report, we will focus on what PAT means in practice for the biotechnological manufacture of pharmaceuticals. Besides a regulatory examination, the monitoring methods and technologies available are thoroughly surveyed. These facts are then reflected against the needs for monitoring in bioprocess-based pharmaceutical production.
Process Analytical Technology: Innovative Pharmaceutical Development
2020
Food and Drug Administration's process analytical technology (PAT) initiative is a collaborative effort with industry to introduce new and efficient manufacturing technologies into the pharmaceutical industry. PAT's are systems for design, analysis, and control of manufacturing processes. 1 The Process Analytical Technology (PAT) initiative aims to move from a paradigm of 'testing quality into 'building quality in by design'. PAT tools are heavily applied in pharmaceutical workflows that underpin drug substance and dosage form development, scale-up, and manufacture. 2 This review introduced the concept of PAT, steps in PAT and it's applications. 3 INTRODUCTION:-Process analytical technology (PAT) is a key element of the "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century-a Risk Based Approach" initiative announced by the FDA in August 2002 to improve and modernize pharmaceutical manufacturing. 4 FDA is issued guidance for industry entitled: "PAT, a framework for innovative pharmaceutical development, measurement and quality assurance" in order to catalyze improvements. 5 PAT forms a part of the Quality by Design (QbD) concept, also a regulatory-inspired methodology. 6
2016 27th Irish Signals and Systems Conference (ISSC), 2016
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 manufacturing pharmaceuticals, emphasising the understanding of process variables on the end products characteristics and transmitting this information upstream to control critical process parameters that effect the critical to quality attributes of a product. Key components of QBD are discussed and their potential impact on current manufacturing processes along with the technological capabilities of PAT and the benefits associated with real-time process monitoring and control.
Process analytical technology (PAT) tools for the cultivation step in biopharmaceutical production
Engineering in Life Sciences, 2013
The process analytical technology (PAT) initiative is now 10 years old. This has resulted in the development of many tools and software packages dedicated to PAT application on pharmaceutical processes. However, most applications are restricted to small molecule drugs, mainly for the relatively simple process steps like drying or tableting where only a limited number of parameters need to be controlled. A big challenge for PAT still lies in applications for biopharmaceuticals and then especially in the cultivation process step, where the quality of a biopharmaceutical product is largely determined. This review gives an overview of the currently available tools for monitoring and controlling the biopharmaceutical cultivation step and of the main challenges for the most common cell platforms (i.e. Escherichia coli, yeast, and mammalian cells) used in biopharmaceutical manufacturing. The real challenge is to understand how intracellular mechanisms (from synthesis to excretion) influence the quality of biopharmaceuticals and how these mechanisms can be monitored and controlled to yield the desired end product quality. Modern "omics" tools and advanced process analyzers have opened up the way for PAT applications for the biopharmaceutical cultivation process step.
Process Analytical Technique (PAT): An Integral Part of Pharmaceutical Process Automation
2017
Process Analytical Technology (PAT) is a system for designing, analyzing and controlling manufacturing process through timely measurements of critical quality and performance attributes of raw materials, in-process materials and processes with the goal of ensuring final product quality as well as reducing manufacturing costs, thereby significantly benefiting the Pharmaceutical Industry in manufacturing area. PAT involves the use of different technologies and tools to build quality into the products. Different techniques are described for typical steps in the production of drug substance and drug product. These methods are mainly based on spectroscopy and other optical sensors, in combination with chemometric multivariate data evaluation tools. Pharmaceutical companies face many challenges while implementing PAT into their new and pre-existing manufacturing processes.
European Journal of Chemistry
Quality by Design (QbD) for the pharmaceutical industry includes the design, development and production control of products and production processes from the beginning to the end of the product development phase for ensuring the consistent quality of a pharmaceutical product. The QbD is a systematic scientific approach aimed at meeting the needs of the patient in the desired and targeted quality and aiming to produce the same quality pharmaceutical product in this direction. Process Analytical Technology, which is assessed in that regard, is part of a design quality approach that is used to design, analyze, and control real-time measurements of quality and performance criteria for raw and processed materials to achieve the desired final product. This scientific and systematic approach to pharmaceutical product development, which is also acknowledged and supported by the health authorities, serves to the changing and developing pharmaceutical sector. KEYWORDS Drug Spectroscopy Quality by design Product development Pharmaceutical industry Process analytical technology Cite this: Eur.
PROCESS ANALYTICAL TECHNOLOGY (PAT) - AS A CULTURE OF INNOVATION
The pharmaceutical industry is in rapid transition from a supply-driven market to a demand and servicedriven market where manufacturing efficiency and responsiveness will play a critical role in future success. To overcome this there is growing enthusiasm in the industry for the many potential gains offered by Process Analytical Technology, a new FDA initiative that aims to foster improvements in manufacturing efficiency and quality analysis. Pharma Industry is facing growing demands for increased productivity and reduced manufacturing costs and also has to meet the evolving need for higher quality standards and higher drug expectations The regulatory area appears to be rapidly evolving, with PAT initiative to be the first major change in the GMP's in over 25 years that is based on increased scientific understanding and less on an empirical based approach. PAT is important because, if it is successfully introduced, it will pioneer a new concept of regulation of quality in the 21 st century.The PAT Approach is based on steps, strategy, cost, benefits and rules during implementation of pat.