scholarly journals Target Product Profile Analysis of COVID-19 Vaccines in Phase III Clinical Trials and Beyond: An Early 2021 Perspective

Viruses ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 418
Author(s):  
Colin D. Funk ◽  
Craig Laferrière ◽  
Ali Ardakani
Keyword(s):  
Messenger Rna ◽  
Viral Vector ◽  
Profile Analysis ◽  
Well Being ◽  
Phase Iii ◽  
Target Product ◽  
Target Product Profile ◽  
Phase Iii Clinical Trials ◽  
Product Profile ◽  
One Year

The coronavirus SARS-CoV-2, which causes Coronavirus disease 2019 (COVID-19), has infected more than 100 million people globally and caused over 2.5 million deaths in just over one year since its discovery in Wuhan, China in December 2019. The pandemic has evoked widespread collateral damage to societies and economies, and has destabilized mental health and well-being. Early in 2020, unprecedented efforts went into the development of vaccines that generate effective antibodies to the SARS-CoV-2 virus. Teams developing twelve candidate vaccines, based on four platforms (messenger RNA, non-replicating viral vector, protein/virus-like particle, and inactivated virus) had initiated or announced the Phase III clinical trial stage by early November 2020, with several having received emergency use authorization in less than a year. Vaccine rollout has proceeded around the globe. Previously, we and others had proposed a target product profile (TPP) for ideal/optimal and acceptable/minimal COVID-19 vaccines. How well do these candidate vaccines stack up to a harmonized TPP? Here, we perform a comparative analysis in several categories of these candidate vaccines based on the latest available trial data and highlight the early successes as well as the hurdles and barriers yet to be overcome for ending the global COVID-19 pandemic.

Quality by Design: Concept to Applications

2019 ◽  
Vol 16 (3) ◽  
pp. 240-250 ◽  
Author(s):  
Suryakanta Swain ◽  
Rabinarayan Parhi ◽  
Bikash Ranjan Jena ◽  
Sitty Manohar Babu
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Products ◽  
Assessment Tools ◽  
Basic Knowledge ◽  
Target Product ◽  
Target Product Profile ◽  
Critical Material ◽  
Novel Approach ◽  
Product Profile ◽  
Performance Report

Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA). Methods: This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components. Results: This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. Conclusion: This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.

scholarly journals The target product profile as a tool for regulatory communication: advantageous but underused

2017 ◽  
Vol 16 (3) ◽  
pp. 156-156 ◽  
Author(s):  
Adria Tyndall ◽  
Wenny Du ◽  
Christopher D. Breder
Keyword(s):  
Target Product ◽  
Target Product Profile ◽  
Product Profile

What’s the Regulatory Value of a Target Product Profile?

2017 ◽  
Vol 35 (7) ◽  
pp. 576-579 ◽  
Author(s):  
Christopher D. Breder ◽  
Wenny Du ◽  
Adria Tyndall
Keyword(s):  
Target Product ◽  
Target Product Profile ◽  
Product Profile

scholarly journals Target Product Profile (TPP) for Chagas Disease Point-of-Care Diagnosis and Assessment of Response to Treatment

2015 ◽  
Vol 9 (6) ◽  
pp. e0003697 ◽  
Author(s):  
Analía I. Porrás ◽  
Zaida E. Yadon ◽  
Jaime Altcheh ◽  
Constança Britto ◽  
Gabriela C. Chaves ◽  
...  
Keyword(s):  
Chagas Disease ◽  
Point Of Care ◽  
Response To Treatment ◽  
Target Product ◽  
Target Product Profile ◽  
Product Profile

scholarly journals Frontrunners in the race to develop a SARS-CoV-2 vaccine

2020 ◽  
Author(s):  
Raquel Russell ◽  
Peter Pelka ◽  
Brian L Mark
Keyword(s):  
Clinical Trials ◽  
Viral Vector ◽  
Protective Efficacy ◽  
Phase Iii ◽  
Protein Subunit ◽  
Vaccine Strategy ◽  
Phase Iii Clinical Trials ◽  
Virus Recombinant ◽  
Potential Risks ◽  
Cellular Immune

Numerous studies continue to be published on the COVID-19 pandemic that is being caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Given the rapidly evolving global response to SARS-CoV-2, here we primarily review the leading COVID-19 vaccine strategies that are currently in Phase III clinical trials. Non-replicating viral vector strategies, inactivated virus, recombinant protein subunit vaccines, and nucleic acid vaccine platforms are all being pursued in an effort to combat the infection. Preclinical and clinal trial results of these efforts are examined as well as the characteristics of each vaccine strategy from the humoral and cellular immune responses they stimulate, effects of any adjuvants used, and the potential risks associated with immunization such as antibody dependent enhancement (ADE). A number of promising advancements have been made toward the development of multiple vaccine candidates. Preliminary data now emerging from phase III clinical trials show encouraging results for the protective efficacy and safety of at least three frontrunning candidates. There is hope that one or more will emerge as potent weapons to protect against SARS-CoV-2.

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