Quality by Design-Driven Process Development of Cell Culture in Bioreactor for the Production of Foot-And-Mouth Veterinary Vaccine

Li, Xinran; Liu, Xuerong; Wang, Rongbin; An, Fanglan; Nie, Jianqi; Zhang, Yunde; Ahamada, Hadji; Liu, Xiuxia; Liu, Chunli; Deng, Yu; Yang, Yankun; Bai, Zhonghu

doi:10.1016/j.xphs.2019.02.004

Cited by 7 publications

(5 citation statements)

References 27 publications

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“…Dissolution rate at 8 h=+108.12500-0.65625 A-0.83125 B (6) Thus for all 4 responses, only two independent factors were found a critical, i.e. concentration of HPMC K4M and HPMC K100M.…”

Section: Resultsmentioning

confidence: 82%

“…Identification of QTPP is followed by the identification of factors which may instigate the QTPP and to further analyze those which do so perilously [5] . These factors are the Critical Quality Attributes (CQAs) of product which eminently depends on the Critical Material Attributes (CMAs) of excipient used in product development along with Critical Process Parameters (CPPs) during manufacturing [6] .…”

Section: Computationalmentioning

confidence: 99%

See 1 more Smart Citation

Scalable Design and Development of Modified Release Hydrochlorothiazide Formulation Employing Quality by Design Approach

Singhai¹,

Sharma²,

Paliwal³

et al. 2022

IJPS

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Singhai et al.: Quality by Design based Scalable Formulation Development of HydrochlorothiazideMyocardial infarction, generally known as 'heart attack' occurs predominantly during the early morning hours and a cause of millions of death worldwide. Hydrochlorothiazide is the recommended drug for the prevention of heart disease, but the commercial market lacks its long action (>4 h) formulation. The endeavor of the present research was to develop a quality product profile of hydrochlorothiazide modified release tablets (~14 h release) by applying computational quality by design approach. Three independent factors were identified by qualitative and quantitative risk assessment. Selected dependent variables were cumulative percent of dissolved hydrochlorothiazide in 2, 5, 8 and 12 h. Graphical tools like half normal, normal and Pareto charts were used to manage model selection. The graphical relationship among the critical, independent variables was represented using contour plot and three-dimensional surface plot. Design space was identified by plotting overlay plot using three factors, two-level full factorial design. Outstanding correlation was observed between predicted and actual values. Similarity factor (F2) of reproducible trials was 78 and 79, and content uniformity was 100.9 % and 100.4 %. Average weight, hardness, thickness, diameter and friability were within acceptable limits. Quality by design approach, along with quality risk management tool furnished an efficient and effective paradigm to structure quality modified release tablets of hydrochlorothiazide.

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“…Dissolution rate at 8 h=+108.12500-0.65625 A-0.83125 B (6) Thus for all 4 responses, only two independent factors were found a critical, i.e. concentration of HPMC K4M and HPMC K100M.…”

Section: Resultsmentioning

confidence: 82%

Section: Computationalmentioning

confidence: 99%

Scalable Design and Development of Modified Release Hydrochlorothiazide Formulation Employing Quality by Design Approach

Singhai¹,

Sharma²,

Paliwal³

et al. 2022

IJPS

View full text Add to dashboard Cite

show abstract

“…Moreover, the implementation of this approach generates an increase in students' practical and scientific skills, as well as confidence in the research group, customers, the industrial sector, and health authorities about the quality of the research, products, and knowledge that are being developed and created in the academy [10,11,73]. Development of green HPLC method for artesunate and amodiaquine impurities Quality control [87] Liquid chromatography method to evaluate cannabinoids content in cannabis olive oil extracts Quality control of natural products [88] Cell culture in bioreactor for the production of foot-and-mouth veterinary vaccine Biopharmaceutical process development [89] Development of electrospinning coatings for metal microneedles Process optimization [90]…”

Section: Quality By Design Approach For Industrial Pharmacy In the Ac...mentioning

confidence: 99%

Quality by Design: A Suitable Methodology in Industrial Pharmacy for Costa Rican Universities

Henríquez¹,

Murillo-Castillo²,

Ramírez-Arguedas³

et al. 2022

Preprint

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The aim of this review is to present the Quality by Design (QbD) model as a suitable methodology to perform research in the academic Costa Rican institutions that teach Pharmacy. Pubmed, Science Direct, and Google Scholar databases were screened for original and review papers, as well as short communications published not more than 10 years ago. Publications were screened by title and abstract. Relevant references were used to develop three important themes: The University’s Research Model in Costa Rica, QbD Model, and QbD as a Research Methodology for Industrial Pharmacy in the Academy. In this sense, the QbD model is a great methodology for carrying out research projects regarding Pharmaceutical Sciences but especially for Drug Development. Academic research based on this model enables training and developing practical, scientific, and leadership skills in pharmacy students. The generated knowledge can be shared in the classrooms, which represents an ideal environment to communicate their research results and to foster collaborative work between researchers, professors, and students. The participation of all these actors allows a high level of commitment to research work, which benefits the scientific advancement of the university and society. It is important to visualize the student body as potential key actors in the research process, encouraging in them the desire to become trained scientific researchers who want to pursue a career in the academy, giving continuity to it.

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“…The empowerment demonstrated by the students during the execution of their graduation projects, and the increase in learning engagement owing to the application of this methodology have also developed leadership and team-work skills, necessary to conduct research [10,11,70]. Development of green HPLC method for artesunate and amodiaquine impurities Quality control [58] Liquid chromatography method to evaluate cannabinoid content in cannabis olive oil extracts Quality control of natural products [59] Cell culture in bioreactor for the production of foot-and-mouth veterinary vaccine Biopharmaceutical process development [80] Development of electrospinning coatings for metal microneedles Process optimization [81] As a result, the QbD model has allowed the creation, transfer, and materialization of knowledge from Costa Rican universities to different local pharmaceutical industries, as discussed in the following sections. Different QbD approaches carried out regarding formulation, the manufacturing process design, and the quality control of drugs and natural products are addressed.…”

Section: Implementation In Academic Researchmentioning

confidence: 99%

Quality by Design: A Suitable Methodology in Industrial Pharmacy for Costa Rican Universities

et al. 2022

View full text Add to dashboard Cite

This review aims to present the Quality by Design (QbD) model as a suitable methodology to perform research in the academic Costa Rican institutions that teach Pharmacy. Pubmed, Science Direct, and Google Scholar databases were screened for original research papers and review papers published not more than ten years ago. Institutional repositories from the different universities were reviewed as well. The QbD model stands out as a great methodology for carrying out research projects regarding Pharmaceutical Sciences, but especially for Industrial Pharmacy, where it has contributed in terms of formulation development, manufacturing, and quality control. Academic research based on this model enables the training and development of practical, scientific, and leadership skills in Industrial Pharmacy students. The generated knowledge can be shared in classrooms, which represents an ideal environment to communicate research results and to foster collaborative work between researchers, professors, and students. Moreover, research performed through a QbD approach increases the confidence shown by the industrial sector and health regulatory authorities in the quality of the research, products, and knowledge that are developed and created in an Academy. As a result, the implementation of the model has allowed the creation, transfer, and materialization of knowledge from the Costa Rican Academy to different local pharmaceutical industries.

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Quality by Design-Driven Process Development of Cell Culture in Bioreactor for the Production of Foot-And-Mouth Veterinary Vaccine

Cited by 7 publications

References 27 publications

Scalable Design and Development of Modified Release Hydrochlorothiazide Formulation Employing Quality by Design Approach

Scalable Design and Development of Modified Release Hydrochlorothiazide Formulation Employing Quality by Design Approach

Quality by Design: A Suitable Methodology in Industrial Pharmacy for Costa Rican Universities

Quality by Design: A Suitable Methodology in Industrial Pharmacy for Costa Rican Universities

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