Process Validation Stage 3: Continued Process Verification

2020 ◽  
pp. 209-232
Author(s):  
Igor Gorsky
Keyword(s):  
Process Validation ◽  
Process Verification ◽  
Validation Stage

scholarly journals Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification

2021 ◽  
Vol 22 (8) ◽  
Author(s):  
Feroz Jameel ◽  
Alina Alexeenko ◽  
Akhilesh Bhambhani ◽  
Gregory Sacha ◽  
Tong Zhu ◽  
...  
Keyword(s):  
Best Practices ◽  
Process Design ◽  
Control Charts ◽  
Batch Size ◽  
Drying Time ◽  
Process Validation ◽  
Process Verification ◽  
Process Qualification ◽  
The Impact ◽  
Validation Strategy

Abstract This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the current paper is devoted to process qualification and continued process verification. The goal of the study is to show the cutting edge of lyophilization validation based on the integrated community-based opinion and the industrial perspective. This study presents best practices for batch size determination and includes the effect of batch size on drying time, process parameters selection strategies, and batch size overage to compensate for losses during production. It also includes sampling strategies to demonstrate batch uniformity as well as the use of statistical models to ensure adequate sampling. Based on the LyoHUB member organizations survey, the best practices in determining the number of PPQ runs are developed including the bracketing approach with minimum and maximum loads. Standard practice around CQA and CPP selection is outlined and shows the advantages of using control charts and run charts for process trending and quality control. The case studies demonstrating the validation strategy for monoclonal antibody and the impact of the loading process on the lyophilization cycle and product quality as well as the special case of lyophilization for dual-chamber cartridge system are chosen to illustrate the process validation. The standard practices in the validation of the lyophilization process, special lyophilization processes, and their impact on the validation strategy are discussed. Graphical Abstract

scholarly journals Workflow for Criticality Assessment Applied in Biopharmaceutical Process Validation Stage 1

2017 ◽  
Vol 4 (4) ◽  
pp. 85 ◽  
Author(s):  
Thomas Zahel ◽  
Lukas Marschall ◽  
Sandra Abad ◽  
Elena Vasilieva ◽  
Daniel Maurer ◽  
...  
Keyword(s):  
Process Validation ◽  
Criticality Assessment ◽  
Stage 1 ◽  
Validation Stage

scholarly journals SWAT Model Adaptability to a Small Mountainous Forested Watershed in Central Romania

Forests ◽  
2021 ◽  
Vol 12 (7) ◽  
pp. 860
Author(s):  
Nicu Constantin Tudose ◽  
Mirabela Marin ◽  
Sorin Cheval ◽  
Cezar Ungurean ◽  
Serban Octavian Davidescu ◽  
...  
Keyword(s):  
Metropolitan Area ◽  
Hydrological Model ◽  
Assessment Tool ◽  
Swat Model ◽  
Decision Makers ◽  
Forested Watershed ◽  
Sensitive Parameters ◽  
Lower Uncertainty ◽  
Validation Stage ◽  
Water Assessment

This study aims to build and test the adaptability and reliability of the Soil and Water Assessment Tool hydrological model in a small mountain forested watershed. This ungauged watershed covers 184 km2 and supplies 90% of blue water for the Brașov metropolitan area, the second largest metropolitan area of Romania. After building a custom database at the forest management compartment level, the SWAT model was run. Further, using the SWAT-CUP software under the SUFI2 algorithm, we identified the most sensitive parameters required in the calibration and validation stage. Moreover, the sensitivity analysis revealed that the surface runoff is mainly influenced by soil, groundwater and vegetation condition parameters. The calibration was carried out for 2001‒2010, while the 1996‒1999 period was used for model validation. Both procedures have indicated satisfactory performance and a lower uncertainty of model results in replicating river discharge compared with observed discharge. This research demonstrates that the SWAT model can be applied in small ungauged watersheds after an appropriate parameterisation of its databases. Furthermore, this tool is appropriate to support decision-makers in conceiving sustainable watershed management. It also guides prioritising the most suitable measures to increase the river basin resilience and ensure the water demand under climate change.

scholarly journals Abnormal upregulation of cardiovascular disease biomarker PLA2G7 induced by proinflammatory macrophages in COVID-19 patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yang Li ◽  
Yongzhong Jiang ◽  
Yi Zhang ◽  
Naizhe Li ◽  
Qiangling Yin ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Normal Limit ◽  
Genomic Analysis ◽  
High Rate ◽  
Hub Gene ◽  
Viral Loads ◽  
Protein Levels ◽  
Nasal Swabs ◽  
Positive Rate ◽  
Validation Stage

AbstractHigh rate of cardiovascular disease (CVD) has been reported among patients with coronavirus disease 2019 (COVID-19). Importantly, CVD, as one of the comorbidities, could also increase the risks of the severity of COVID-19. Here we identified phospholipase A2 group VII (PLA2G7), a well-studied CVD biomarker, as a hub gene in COVID-19 though an integrated hypothesis-free genomic analysis on nasal swabs (n = 486) from patients with COVID-19. PLA2G7 was further found to be predominantly expressed by proinflammatory macrophages in lungs emerging with progression of COVID-19. In the validation stage, RNA level of PLA2G7 was identified in nasal swabs from both COVID-19 and pneumonia patients, other than health individuals. The positive rate of PLA2G7 were correlated with not only viral loads but also severity of pneumonia in non-COVID-19 patients. Serum protein levels of PLA2G7 were found to be elevated and beyond the normal limit in COVID-19 patients, especially among those re-positive patients. We identified and validated PLA2G7, a biomarker for CVD, was abnormally enhanced in COVID-19 at both nucleotide and protein aspects. These findings provided indications into the prevalence of cardiovascular involvements seen in patients with COVID-19. PLA2G7 could be a potential prognostic and therapeutic target in COVID-19.

scholarly journals Injectable Hydrogels: From Laboratory to Industrialization

Polymers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 650
Author(s):  
Jose Maria Alonso ◽  
Jon Andrade del Olmo ◽  
Raul Perez Gonzalez ◽  
Virginia Saez-Martinez
Keyword(s):  
Industrial Process ◽  
Functional Materials ◽  
Point Of View ◽  
Industrial Scale ◽  
Injectable Hydrogels ◽  
Safety And Efficacy ◽  
Process Validation ◽  
Characterization Techniques ◽  
Hyaluronic Acid Hydrogel ◽  
Lack Of Knowledge

The transfer of some innovative technologies from the laboratory to industrial scale is many times not taken into account in the design and development of some functional materials such as hydrogels to be applied in the biomedical field. There is a lack of knowledge in the scientific field where many aspects of scaling to an industrial process are ignored, and products cannot reach the market. Injectable hydrogels are a good example that we have used in our research to show the different steps needed to follow to get a product in the market based on them. From synthesis and process validation to characterization techniques used and assays performed to ensure the safety and efficacy of the product, following regulation, several well-defined protocols must be adopted. Therefore, this paper summarized all these aspects due to the lack of knowledge that exists about the industrialization of injectable products with the great importance that it entails, and it is intended to serve as a guide on this area to non-initiated scientists. More concretely, in this work, the characteristics and requirements for the development of injectable hydrogels from the laboratory to industrial scale is presented in terms of (i) synthesis techniques employed to obtain injectable hydrogels with tunable desired properties, (ii) the most common characterization techniques to characterize hydrogels, and (iii) the necessary safety and efficacy assays and protocols to industrialize and commercialize injectable hydrogels from the regulatory point of view. Finally, this review also mentioned and explained a real example of the development of a natural hyaluronic acid hydrogel that reached the market as an injectable product.

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