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Ajinomoto Bio-Pharma Services presenta la plataforma de aprobación por la vía rápida AJILITY
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Jun 30, 2020, 08:10 ET

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- Ajinomoto Bio-Pharma Services presenta la plataforma de aprobación por la vía rápida AJILITY para fabricación de productos fármacos

SAN DIEGO, 30 de junio de 2020 /PRNewswire/ -- Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), destacado proveedor de servicios biofarmacéuticos de fabricación y desarrollo por contrato, se complace al anunciar el lanzamiento de AJILITY™, plataforma de fabricación de producto de fármacos flexible y ágil, diseñada para avanzar vacunas y terapias para el mercado que minimizan el tiempo de producción.

La plataforma AJILITY de Aji Bio-Pharma, se ha diseñado para las nuevas vacunas/productos terapéuticos y productos fármacos existentes con una nueva indicación que se puede usar en ensayos de la COVID-19, Emergency Use Authorizations (EUA) de la FDA u otros programas, proporcionando una flexibilidad mejorada para implementar nuestras configuraciones de proyectos mejoradas existentes. Con AJILITY, de Aji Bio-Pharma, los clientes van a disponer de acceso a nuestra experiencia, con conocimiento para guiarles a través de las decisiones de los componentes y excipientes para las cualificaciones de métodos. El objetivo de la plataforma AJILITY es minimizar las variables durante la transferencia tecnológica, procesos de fabricación y envío, además de basarse en nuestra experiencia normativa para navegar por los entresijos de la producción tradicional para conseguir de forma rápida terapias para las clínicas.

"La plataforma AJILITY ofrece flexibilidad y ahorro de tiempo, lo que supone un impulso importante para los clientes con productos de fármacos que necesitan entrar en ensayos clínicos de forma rápida", destacó Dustin Campbell, director asociado de operaciones comerciales de Ajinomoto Bio-Pharma Services. "Como principal CDMO para la fabricación de productos fármacos, sabemos que hay algunos detalles del programa que afectan a la línea de tiempo de fabricación más que otros. La plataforma AJILITY utiliza la amplia experiencia de Aji Bio-Pharma en fabricación y visión normativa para los programas de mercado de aprobación por la vía rápida para los clientes".

"Estamos emocionados de introducir la plataforma AJILITY a nuestra base de clientes interesados en nuestra aproximación de asociación progresiva para avanzar sus productos terapéuticos para los pacientes", indicó Kristin DeFife, Ph.D. y vicepresidenta senior de operaciones y dirección de instalaciones de Ajinomoto Bio-Pharma Services. "La plataforma AJILITY se ha desarrollado por medio de un equipo de departamento funcional que proporciona a nuestros clientes acceso a los procesos de fabricación de productos de fármacos preferidos, junto a nuestra experiencia en los envíos normativos, desarrollo de procesos y configuraciones de envíos en nuestra instalación sita en San Diego, California".

Si desea conocer más acerca del programa AJILITY, visite: www.AjiBio-Pharma.com/AJILITY.

Acerca de Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services es una organización totalmente integrada de desarrollo y fabricación por contrato con sedes en Bélgica, Estados Unidos, Japón y La India, la cual presta servicios integrales de desarrollo, fabricación de cGMP y llenado y acabado asépticos para las API de moléculas pequeñas y grandes y sus intermediarios. Ajinomoto y Ajinomoto Bio-Pharma Services ofrecen una amplia gama de capacidades y plataformas innovadoras para programas preclínicos y pilotos y hasta cantidades comerciales, que incluyen la tecnología de expresión de proteínas Corynex®, síntesis de oligonucleótidos, conjugaciones de anticuerpos farmacológicos (ADC), uso de las API de alta potencia (HPAPI), biocatálisis, fabricación de flujo continuo y más. Ajinomoto Bio-Pharma Services se dedica a proveer un alto nivel de calidad y servicio para satisfacer las necesidades de nuestros clientes. Si desea conocer más visite la página web: www.AjiBio-Pharma.com

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