<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0121-4004</journal-id>
<journal-title><![CDATA[Vitae]]></journal-title>
<abbrev-journal-title><![CDATA[Vitae]]></abbrev-journal-title>
<issn>0121-4004</issn>
<publisher>
<publisher-name><![CDATA[Facultad de Química Farmacéutica, Universidad de Antioquia]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0121-40042022000200003</article-id>
<article-id pub-id-type="doi">10.17533/udea.vitae.v29n2a348750</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[A review on risk assessment of formulation development and technology transfer of COVID-19 vaccines]]></article-title>
<article-title xml:lang="es"><![CDATA[Una revisión sobre la evaluación de riesgos del desarrollo de formulaciones y la transferencia de tecnología de las vacunas COVID-19]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hari]]></surname>
<given-names><![CDATA[V]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vivek Reddy]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ganesh]]></surname>
<given-names><![CDATA[GNK]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Suhaib Ahmed]]></surname>
<given-names><![CDATA[Syed]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,JSS Academy of Higher Education &amp; Research JSS College of Pharmacy Department of Regulatory Affairs]]></institution>
<addr-line><![CDATA[Ooty, Nilgiris Tamilnadu]]></addr-line>
<country>India</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,JSS Academy of Higher Education &amp; Research JSS College of Pharmacy Department of Regulatory Affairs]]></institution>
<addr-line><![CDATA[Ooty, Nilgiris Tamilnadu]]></addr-line>
<country>India</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,JSS Academy of Higher Education &amp; Research JSS College of Pharmacy Department of Regulatory Affairs]]></institution>
<addr-line><![CDATA[Ooty, Nilgiris Tamilnadu]]></addr-line>
<country>India</country>
</aff>
<aff id="Af4">
<institution><![CDATA[,JSS Academy of Higher Education &amp; Research JSS College of Pharmacy Department of Pharmaceutics]]></institution>
<addr-line><![CDATA[Ooty, Nilgiris Tamilnadu]]></addr-line>
<country>India</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2022</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2022</year>
</pub-date>
<volume>29</volume>
<numero>2</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0121-40042022000200003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0121-40042022000200003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0121-40042022000200003&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Background: COVID-19 pandemic situation made the pharmaceutical companies develop the vaccine with different formulations in a short period.  Objectives: The main objective of the review is to focus on different types of vaccine formulations available globally and the importance of technology transfer in vaccine development associated with potential risks.  Results: Research on vaccine development led to various types of vaccines, such as Inactivated vaccines, Live Attenuated vaccines, Ribonucleic acid (RNA) and Deoxyribonucleic acid (DNA) vaccines, viral vector vaccines, and Protein Subunit Vaccines for COVID-19. But the process of vaccine development and technology transfer is lined with various risks and challenges. Through risk assessment, we found some major potential risks involved in product development; this leads to a smoother and more efficient method to develop safe vaccines available for public health.  Conclusions: This review will explain the significance of technology collaboration for the faster development of various formulations of vaccines globally.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Antecedentes: La situación de pandemia de COVID-19 hizo que las empresas farmacéuticas desarrollaran la vacuna con diferentes formulaciones en un corto período.  Objetivos: El objetivo principal de la revisión es centrarse en los diferentes tipos de formulaciones de vacunas disponibles a nivel mundial y la importancia de la transferencia de tecnología en el desarrollo de vacunas asociado con los riesgos potenciales.  Resultados: La investigación sobre el desarrollo de vacunas condujo al desarrollo de varios tipos de vacunas, como vacunas inactivadas, vacunas vivas atenuadas, vacunas de ácido ribonucleico (ARN) y ácido desoxirribonucleico (ADN), vacunas de vectores virales y vacunas de subunidades de proteínas para COVID-19. Pero el proceso de desarrollo de vacunas y transferencia de tecnología está lleno de varios riesgos y desafíos. A través de la evaluación de riesgos, encontramos algunos riesgos potenciales importantes involucrados en el desarrollo de productos, lo que conduce a un método más fluido y eficiente para desarrollar vacunas seguras disponibles para la salud pública.  Conclusiones: Esta revisión dará una idea de la importancia de la colaboración tecnológica para el desarrollo más rápido de varias formulaciones de vacunas a nivel mundial.]]></p></abstract>
<kwd-group>
<kwd lng="en"><![CDATA[Vaccine development]]></kwd>
<kwd lng="en"><![CDATA[Technology transfer]]></kwd>
<kwd lng="en"><![CDATA[Risk assessment]]></kwd>
<kwd lng="en"><![CDATA[COVID - 19 vaccines]]></kwd>
<kwd lng="es"><![CDATA[desarrollo de vacunas]]></kwd>
<kwd lng="es"><![CDATA[transferencia de tecnología]]></kwd>
<kwd lng="es"><![CDATA[evaluación de riesgos]]></kwd>
<kwd lng="es"><![CDATA[vacunas COVID - 19]]></kwd>
</kwd-group>
</article-meta>
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